[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":575},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,56,0,25,[9,44,67,91,120,142,164,183,206,228,252,273,291,316,334,360,381,404,427,446,471,491,509,530,553],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100641549","discovering-determinants-of-food-intake-by-application-of-artificial-intelligence-to-complex-high-dimensional-data-100641549",false,"NCT07637656","Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data","Discovering Determinants of Food Intake by Application of Machine Learning to Complex, High-Dimensional Data","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Age 18 to 60\n3. In good general health as evidenced by medical history and physical exam\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Weight \\>=204 kg (\\>=450 pounds, maximum weight of the iDXA machine as per manufacturer s manual), or weight \\\u003C45.4 kg (\\\u003C100 pounds, minimum weight allowed based on the NIH guidelines of blood drawing for research purposes)\n2. Unstable weight (+\u002F-5%) within past 6 months as determined by volunteer self-report.\n3. Current use of medications, dietary supplements, or alternative therapies known to alter energy metabolism\n4. Inability to consume provided food based on food allergy or intolerance or other food restrictions (e.g., kosher, vegan, or vegetarian)\n5. Current pregnancy, or recent pregnancy within past 6 months or currently lactating\n6. History or clinical manifestation of:\n\n6i. Diabetes, including fasting glucose \\>= 126 mg\u002Fdl or HbA1c \\>= 6.5%, or history\n\n6ii. Surgery for treatment of obesity\n\n6iii. Endocrine disorders, such as Cushing s disease, pituitary disorders, or hypo- and hyperthyroidism (TSH \\\u003C0.1 or \\>= 10 uIU\u002FmL)\n\n6iv. Pulmonary disorders including chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol\n\n6v. History of coronary artery disease, heart failure, arrhythmias, and peripheral artery disease that which would limit ability to follow the protocol\n\n6vi. Liver disease, including cirrhosis, active hepatitis B or C based on history, and AST or ALT \\>= 3x normal\n\n6vii. Gastrointestinal disease including Crohn's disease, ulcerative colitis, celiac disease, or other malabsorptive disorders by history\n\n6viii. Hematologic disorders including significant anemia (male hemoglobin \\\u003C 13.0 g\u002FdL or female hemoglobin \\\u003C 11.0 g\u002FdL)\n\n6ix. Renal disease including abnormal kidney function (eGFR \\\u003C60 mL\u002Fmin\u002F1.73m\\^2)\n\n6x. Central nervous system disease, including cerebrovascular accidents, dementia, and neurodegenerative disorders by history\n\n6xi. Cancer requiring treatment in the past 5 years, except for nonmelanoma skin cancers or cancers that have clearly been cured\n\n6xii. Infectious disease such as active tuberculosis, HIV (by self-report), chronic coccidiomycosis or other chronic infections that might influence appetite\n\n6xiii. Diagnosis of binge eating disorder, anorexia, or major psychiatric disorders including depression, schizophrenia, and psychosis\n\n6xiv. Menopausal transition (late) to early postmenopause (e.g., \\>= 2 skipped cycles and an interval of amenorrhea \\>= 60 days and \\\u003C12 months)\n\n7\\. Alcohol abuse as defined by \\>= 8-point score on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire interview\n\n8\\. Inability to provide informed consent\n\n9\\. Any disorder, unwillingness, or inability not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators, such as those that jeopardize the safety of the participant or others, or would interfere with completion of study procedures","ALL","18 Years","60 Years",{"count":21,"type":22},800,"ESTIMATED","OBSERVATIONAL","Background:\n\nMany people in the United States are overweight or obese. Researchers want to learn why some people can overeat and not gain weight, whereas others who do not overeat still gain weight.\n\nObjective:\n\nTo study factors related to food intake that can lead to weight gain over time.\n\nEligibility:\n\nHealthy adults aged 18 to 60 years.\n\nDesign:\n\nParticipants will have 6 to 8 clinic visits over 2 years. The first 3 or 4 study visits will be 1 week apart.\n\nProcedures during visits may include the following:\n\nCollection of blood, hair, urine, and stool samples.\n\nMeasurement of the waist, neck, thighs, and other parts of the body.\n\nDual energy x-ray absorption (DXA) scan: Participants will lie still on a padded table while they are scanned to measure body fat.\n\nPhysical activity monitor: Participants will wear a monitor on the wrist for 2 weeks.\n\nCognitive tests: Participants will perform tasks to measure attention, memory, and brain function.\n\nContinuous glucose monitor. Participants will wear a device that measures their blood glucose for 1 week.\n\nMixed meal test and stomach emptying test. Participants will drink a breakfast shake and swallow a dose of acetaminophen. Blood will be drawn over the next 4 hours.\n\nResting metabolic rate: Participants will wear a clear hood over their head while they rest for 20 minutes. The hood will measure the gases they breathe.\n\nBreakfast and lunch test. Participants will eat a standard breakfast. They will be allowed to select from foods and eat as much as they like at lunch. They will be asked how hungry or full they are.\n\nQuestionnaires. Participants will answer questions about their health, sleep, physical activity, and eating.",[26],"Healthy Volunteer",[28,29,30],"Food Intake","Energy Expenditure","Artificial Intelligence","NOT_YET_RECRUITING","2026-08-20",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":22},"2026-08-26",{"date":39,"type":22},"2037-07-01",{"name":41,"class":42},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100641419","longitudinal-immunophenotyping-of-patients-with-inflammatory-bowel-disease-100641419","NCT07619547","Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nAffected Participant cohort:\n\n1. Adults 18 - 85 years of age\n2. History of:\n\n   1. a verifiable diagnosis of Crohn's disease, ulcerative colitis, or IBD known to be associated with a co-existing condition (such as CTLA4 deficiency or common variable immune deficiency) and which is supported by characteristic clinical features, radiographic or endoscopic findings, or consistent histopathologic mucosal changes related to chronic inflammation; and\u002For\n   2. a defined genetic syndrome\u002Fmutation linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD\n3. Presence of a referring community physician who would be able to manage care outside of NIH\n\nUnaffected family member of participant: immediate relative to the enrolled participant (mother, father, sibling, or adult child) may be recruited and enrolled to improve interpretation of genetic results or expand the phenotype of the IBD\n\n1. Adults 18 - 99 years of age\n2. In good general health\n3. No medical diagnosis of IBD\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Unable or unwilling to provide informed consent\n2. Evidence of significant medical illnesses that the investigators feel may interfere with study evaluations and procedures","85 Years",{"count":52,"type":22},100,"Background:\n\nInflammatory bowel disease (IBD) is a term used to describe disorders that cause long-term inflammation in the digestive tract. Symptoms include stomach pain, diarrhea, and bleeding. Crohn's disease and ulcerative colitis are the 2 main types of IBD. Researchers want to conduct a natural history study to learn more about whether genetic factors can cause IBD; how immune cells contribute to IBD; and how diet, drugs, and disease affect those cells.\n\nObjective:\n\nTo better understand IBD over time.\n\nEligibility:\n\nAdults aged 18 to 85 years with Crohn's disease, ulcerative colitis, or another IBD. Their healthy relatives are also needed.\n\nDesign:\n\nAffected participants will have clinic visits every 6 months for 3 years.\n\nOnce a year, they will have these procedures:\n\nA physical exam with blood and stool samples.\n\nUltrasound of the abdomen. A wand will be rolled over the skin. It uses sound waves to capture images of the intestines.\n\nMagnetic resonance imaging (MRI) scan. They will lie on a table that slides into a tube. Magnetic fields will capture images of the intestines.\n\nColonoscopy. A long, flexible tube with a video camera will be inserted into the rectum to view the entire colon. Up to 12 tissue samples may be taken.\n\nUpper endoscopy, for those with Crohn's disease. A long, thin tube with a camera will be inserted through the mouth and into the first part of the small intestine. Up to 12 small tissue samples may be taken.\n\nQuestionnaires. Participants will answer questions about their disease and their diet.\n\nMidyear visits will include a physical exam, blood and stool collection, ultrasound, and questionnaires\n\nHealthy relatives will have 1 blood draw for genetic tests.",[55,56,57],"Inflammatory Bowel Disease","Crohn's Disease","Ulcerative Colitis",[59,60,61],"Immune System","Inflammation","gastroenterology",{"date":34,"type":35},{"date":37,"type":22},{"date":65,"type":22},"2036-06-01",{"name":41,"class":42},{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":90,"locationsCount":43},"100622816","evaluation-of-the-clinical-spectrum-of-diabetes-and-obesity-in-youth-and-adults-100622816","NCT07388537","Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age 8 years to 65 years\n2. Meet at least one of the following:\n\n   a. Overweight\u002FObesity:\n\n   i. For participants under 18 years of age: BMI \\>= 85th percentile for age and sex\n\nii. For participants \\>= 18 years of age: BMI \\>= 25 kg\u002Fm\\^2 (\\>=23 kg\u002Fm\\^2 for self-reported Asian race\u002Fethnicity)\n\nb. Suspected or evidence of hyperglycemia:\n\ni. Diagnosis of prediabetes or diabetes in medical history or by participant\u002Fguardian\u002FLegally Authorized Representative (LAR) report, OR\n\nii. Fasting blood glucose \\>= 100 mg\u002FdL in medical record, OR\n\niii. Postprandial blood sugar \\>= 140 mg\u002FdL in medical record, OR\n\niv. Hemoglobin A1c \\>= 5.7% in medical record\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History of significant medical illnesses that the investigators feel may interfere with potential evaluations, i.e. individuals who are critically ill, unstable, or with severe organ failure that may affect\u002Flimit the endocrine evaluation and place unsustainable demands on Clinical Center or NIDDK resources.\n2. History of any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the participant.\n3. Inability or unwillingness of participant, parent\u002Fguardian, or LAR to provide informed consent.","8 Years","65 Years",{"count":76,"type":22},1000,"Background:\n\nDiabetes and obesity are chronic diseases. They can affect blood flow and how the body processes nutrients, and complications over time can lead to early death. Diabetes can affect children as well as adults, but the disease seems to be more severe and to progress faster when it appears in younger people. Researchers want to understand more about how diabetes and obesity develop and change over time.\n\nObjective:\n\nTo collect data and samples regularly from people with obesity and diabetes.\n\nEligibility:\n\nPeople aged 8 to 65 years. They must be overweight or obese; or have high blood sugar; or have problems with how their body uses food for energy.\n\nDesign:\n\nParticipants will have additional procedures during routine care visits at the NIH clinic.\n\nData collected for the study will include the following:\n\nInformation from the participant s medical chart will be kept for research.\n\nQuestionnaires will ask about participant s eating habits, feelings, sleep, and substance use. They will take 30 to 60 minutes. Care providers will address any issues revealed in these surveys.\n\nBlood, saliva, urine, and stool samples will be collected. Samples may be used for genetic tests.\n\nData and samples will be kept for future research.\n\nParticipants may remain in the study up to 30 years.",[79,80,81],"Obesity","Diabetes","Metabolic Disorders",[83,79,84,85],"Clinical Spectrum of Diabetes","Hyperglycemia","Metabolic Disease",{"date":34,"type":35},{"date":37,"type":22},{"date":89,"type":22},"2055-04-30",{"name":41,"class":42},{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":109,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":117,"leadSponsor":119,"locationsCount":43},"100617066","effects-of-meal-macronutrients-on-postprandial-lipids-100617066","NCT07313787","Effects of Meal Macronutrients on Postprandial Lipids","Prospective Cross-Over Study of the Effects of Meal Macronutrients on Postprandial Lipids","* INCLUSION CRITERIA:\n\nCommon inclusion criteria (all groups):\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age \\>= 18 years\n2. Average alcohol intake in the past 6 months \\\u003C 3 drinks (approximately 30g) per day (male) or \\\u003C 2 drinks (approximately 20 g) per day (female)\n\nHealthy control specific inclusion criteria:\n\n1. In good general health with no known active medical conditions as evidenced by medical history\n2. Fasting glucose \\\u003C100 mg\u002FdL\n3. HbA1c \\\u003C5.7%\n4. Fasting triglycerides \\\u003C150 mg\u002FdL\n5. ALT and AST within normal limits\n6. BMI \\>=18.5 to \\\u003C25 kg\u002Fm\\^2 (or \\\u003C23 kg\u002Fm\\^2 in participants of Asian descent)\n7. Not taking any medications or supplements that, in the opinion of the investigator, would interfere with interpretation of study data.\n\nMetabolic syndrome specific inclusion criteria\n\n1. Obesity defined as either\n\n   1. BMI \\>30 kg\u002Fm\\^2 (or \\>=27 kg\u002Fm\\^2 in participants of Asian descent), OR\n   2. Elevated waist circumference as defined below:\n\n      * Country\u002FEthnic group - Europid, Sub-Saharan African, Eastern Mediterranean and Middle East (Arab):\n\n        * Sex: Male; Waist circumference: \\>=94cm\n        * Sex: Female; Waist circumference: \\>=80cm\n      * Country\u002FEthnic group - South Asian, Chinese, Japanese, Ethnic South and Central American:\n\n        * Sex: Male; Waist circumference: \\>=90cm\n        * Sex: Female; Waist circumference: \\>=80cm\n\n   Plus any 2 of the following\n2. Elevated triglycerides defined as EITHER\n\n   1. Fasting triglycerides \\>= 150 mg\u002FdL at screening, OR\n   2. Specific treatment for hypertriglyceridemia\n3. Low HDL cholesterol, defined as EITHER\n\n   1. HDL \\\u003C40 mg\u002FdL (males) or \\\u003C50 mg\u002FdL (females) at screening, OR\n   2. Specific treatment for low HDL\n4. Elevated blood pressure defined as EITHER\n\n   1. Systolic BP \\>= 130 at screening, OR\n   2. Diastolic BP \\>= 85 mm Hg at screening, OR\n   3. Treatment of previously diagnosed hypertension\n5. Elevated glucose defined as EITHER\n\n   1. HbA1c \\>= 5.7% (at screening), OR\n   2. Fasting serum glucose \\>= 100 mg\u002FdL (at screening), OR\n   3. 2-hour post-load glucose levels \\>= 140 mg\u002FdL (by history), OR\n   4. Prior diagnosis of type 2 diabetes\n\nLipodystrophy-specific inclusion criteria:\n\n1. Clinical diagnosis of generalized or partial lipodystrophy based on reduction in adipose tissue outside the normal range in some or all adipose depots (including, at a minimum, the gluteofemoral depot).\n2. Insulin resistance as defined by fasting insulin \\>22.5 or high exogenous insulin requirement (\\> 2 units per kg per day or \\> 200 units total per day) at screening.\n\nNephrotic syndrome specific inclusion criteria\n\n1. History of biopsy proven non-diabetic glomerular disease (any histology)\n2. Nephrotic range proteinuria defined by ANY of the following:\n\n   1. Protein\u002Fcreatinine ratio uPCR \\>= 3.5 g\u002Fg at screening, OR\n   2. 24 hour protein excretion \\>= 3.5 gr\u002F24hr) at screening, OR\n   3. History of nephrotic range proteinuria (as defined above) within the past 5 years but in complete (defined as proteinuria \\\u003C= 0.3 g\u002Fday or partial remission (defined as a 50% or greater decrease in proteinuria compared to baseline and proteinuria \\\u003C 3.5 g\u002Fday) based on 24 hr urine or uPCR at time of screening\n\nEXCLUSION CRITERIA:\n\nCommon exclusion criteria (all groups):\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Consuming extreme macronutrient diet (e.g., very low-carbohydrate, high fat diets such as ketogenic, \"paleo\" or Atkins diets, among others).\n2. Plans to actively gain or lose weight during the study period (other than changes in water balance as clinically needed in subjects with nephrotic syndrome).\n3. Change in body weight of \\>5% or \\>3 kg (whichever is larger) in the 3 months prior to screening (by participant report) in participants who do NOT have nephrotic syndrome.\n4. Body weight \\>450 lbs (upper limit that can be accommodated by DXA scanner).\n5. Participating in a regular strenuous exercise program (\\> 2h\u002Fweek of vigorous activity) as determined by volunteer report or evidence of vigorous exercising in order to lose weight, change body shape, or to counteract the effects of eating.\n6. Uncontrolled diabetes, defined as HbA1c \\>9% at screening.\n7. Lipemia defined as fasting or non-fasting triglycerides of \\>1000 mg\u002FdL at screening.\n8. Renal dysfunction defined as eGFR \\\u003C50 mL\u002Fmin\u002F1.73 m\\^2 at screening.\n9. In participants with liver disease, history of decompensated advanced liver disease, defined as direct bilirubin \\> 0.5 g\u002FdL, PT \\> 18 seconds, albumin \\\u003C 3 g\u002FdL, MELD score \\> 12, or history of ascites, encephalopathy, variceal bleeding, spontaneous bacterial\n\n   peritonitis or liver transplant.\n10. History of hypertriglyceridemia-induced pancreatitis within 3 months prior to screening.\n11. Positive pregnancy test or breastfeeding at screening.\n12. Clinically significant abnormalities in thyroid function, blood counts, as assessed by screening labs.\n13. Acute cardiovascular events within the past 6 months\n14. Anemia (Hgb \\\u003C10 mg\u002FdL in women or \\\u003C12 mg\u002FdL in men) at screening\n15. Food allergies or other dietary restrictions that could increase risk associated with test meals or cause the subject to be unwilling to consume test meals (i.e. celiac disease, vegan diets).\n16. Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.\n17. Subjects treated with tamoxifen, estrogens, or progestins that have not been stable for \\>4 weeks prior to screening.\n18. Blood donation in the last 2 weeks or planned blood donation during the study\n19. Subjects requiring regular transfusions for any reason.\n20. Subjects with known gastroparesis\n21. Inability to adhere to Lifestyle Considerations throughout study duration.\n22. Inability of the subject to understand and the unwillingness to sign a written informed consent document.\n23. Unwillingness to comply with all study procedures and unavailable for the duration of the study\n24. Any other condition or medication which, in the opinion of the investigator, increases risk to the subject, prevents the subject from complying with study procedures, prevents the subject from completing the study, or interferes with the interpretation of study results.","120 Years",{"count":52,"type":22},"INTERVENTIONAL",[102],"PHASE2","Background:\n\nAbnormal fats in the blood can lead to many problems, including heart disease. Researchers want to learn more about how eating meals with different levels of nutrients affects fats in the blood. Specifically, they want to study people with too much body fat, too little body fat, and a kidney problem called nephrotic syndrome.\n\nObjective:\n\nTo learn more about how different types of foods affect fat levels in the blood.\n\nEligibility:\n\nPeople aged 18 years or older with a health condition that affects how their body handles fats. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 2 overnight stays in the clinic within 6 months. At each visit, after staying overnight, they will eat a breakfast casserole. At 1 visit, breakfast will be a high-fat, low carbohydrate meal. At the other, it will be a high-carbohydrate, low-fat meal.\n\nParticipants will have a tube inserted into a vein in their arm. They will have blood drawn via the tube 12 times in 8 hours: 2 times before they eat the breakfast and 10 times after.\n\nParticipants will have other tests during their stays:\n\n* A resting metabolic test captures the air they exhale and measures how much energy they use at rest.\n* A dual energy X-ray absorptiometry (DXA) scan measures how much fat and muscle they have.\n* A Fibroscan is a special type of ultrasound of the liver.\n* A body surface scan uses lasers to measure the total area of the body.\n* A bioelectric impedance (BIS) exam measures how fast small electric currents move through their body.\n\nParticipants may opt to have a third visit. At this visit, the breakfast will be high in protein....",[105,106,107,26,80,108],"Nephrotic Syndrome","Lipodystrophy","Metabolic Syndrome","Metabolic Associated Steatotic Liver Disease",[110,111,112,113,114],"postprandial lipids","macronutrient","CARBOHYDRATES","FATS","Proteins",{"date":34,"type":35},{"date":37,"type":22},{"date":118,"type":22},"2031-08-01",{"name":41,"class":42},{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":139,"leadSponsor":141,"locationsCount":43},"100607669","hepatic-lipid-metabolism-alcohol-use-disorder-100607669","NCT07191561","Hepatic Lipid Metabolism-Alcohol Use Disorder","Mechanisms in Hepatic Lipid Metabolism in Alcohol Use Disorder: From Genomics, Transcriptomics to Metabolomics","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Any individual \\>=18 years of age who is enrolled in 14-AA-0181 and is seeking inpatient treatment.\n* Vibration Controlled Elastography parameters with initial CAP of \\>295dB\u002Fm.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnancy\n* Existing diagnosis of hyperlipidemia or essential hypertension\n* Hemoglobin A1c \\>= 6.5%\n* Waist to hip ratio: \\>=0.90 in males, \\>=0.85 in females\n* Existing use of cholesterol lowering medications including statins, fibrates, or other similar medications used for the purposes of treating hyperlipidemia.\n* Those with evidence of severe alcoholic hepatitis with a Maddrey s Discriminant Function \\> 32\n* Those with other chronic liver diseases including chronic hepatitis B (positive hepatitis B surface Ag on admission), hepatitis C (positive hepatitis C RNA), or autoimmune hepatitis (clinical diagnosis based on high titer of positive ANA and or anti smooth muscle Ab and a history of autoimmune disease)\n* HIV infection\n* Contraindication or inability to perform a liver biopsy.\n\n  * Participants with coagulopathy (PT\u002FPTT values that are prolonged (Bullet) 3 seconds from the upper limit of the normal, including treatment with oral and parenteral anticoagulants), thrombocytopenia (\\\u003C 70,000), abnormal bleeding time or platelet dysfunction. Antiplatelet agents taken for cardiovascular prevention will not exclude participants, unless they cannot be stopped safely for the performance of a liver biopsy.\n  * Hemoglobin level \\\u003C 11 g\u002FdL\n  * Inability to provide informed consent.","100 Years",{"count":7,"type":22},"Patients with hepatic steatosis due to alcohol will be offered liver biopsies when they enter a detoxification program. The first biopsy will occur in the first week of admission and the second in the fourth week when the steatosis has resolved. The hepatic transcriptome will be compared,",[131],"Alcohol Use Disorder",[133,134,135],"Alcohol","Liver","Biopsy","RECRUITING",{"date":34,"type":35},{"date":37,"type":22},{"date":140,"type":22},"2029-11-30",{"name":41,"class":42},{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":149,"targetDuration":4,"studyType":100,"phases":151,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":161,"leadSponsor":163,"locationsCount":43},"100592308","177lu-dota-eb-tate-in-adult-patients-with-metastatic-radioactive-iodine-non-responsive-oncocytic-hurthle-cell-thyroid-cancer-100592308","NCT06991738","177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer","Phase 1\u002F2, Open-Label Study of the Safety, Dosimetry and Efficacy of a 3-Dose Regimen of Escalating Doses of 177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Aged 18 years or older.\n* Metastatic RAI-non-responsive and\u002For RAI-non-avid oncocytic (Hurthle cell) thyroid cancer.\n* Progressive disease by RECIST 1.1 criteria, with or without symptoms within the last 12 months. This applies to patients with non-measurable disease by RECIST 1.1 criteria, who will be eligible if they have evidence of progression as defined by the development of new lesions within the last 12 months.\n* High expression of SSTR2 in at least one metastatic lesion as documented by 68Ga-DOTATATE PET\u002FCT with SUVmax \\> SUVmax of the liver consistent with Krenning score of \\>2 or SUVmax \\>= 13 based on scan performed within 12 weeks of anticipated enrollment.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant or breastfeeding.\n* NET\u002FPET score of 5 by imaging with 68Ga-DOTATATE PET\u002FCT and 18FDG-PET\u002FCT and defined more than 2 lesions that are SSTR2 negative but 18FDG positive and\u002For more than 2 lesions that have significantly higher uptake of 18FDG than 68Ga-DOTATATE\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTA-EB-TATE as assessed from medical record.\n* Patient weight \\> 500 lbs. (due to the PET scanner table limit).\n* Inability to tolerate at least one modality of diagnostic anatomic imaging, such as CT or MRI.\n* Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 4 weeks or 4 half-lives (whichever is longer), before the first administration of study drug.\n* Previous surgery \\\u003C 6 weeks prior to the start of participation in this study, or participant has not fully recovered from major surgery, or has suffered significant traumatic injury prior the first dose of study drug or expects to have major surgery during the study period or within 3 months after the last dose of study drug.\n* Life expectancy \\\u003C 6 months as assessed by the treating physician.\n* Karnofsky performance status scale \\\u003C 70%.\n* Inability or unwillingness to use adequate contraception prior to study entry and for the duration of study participation, including follow-up (7 months after the last dose of study drug for women and 4 months for men). The adequate contraception consists of intrauterine device, contraceptive implant, hormonal contraception or a double-barrier method. If the patient is status post tubal ligation, status post hysterectomy and\u002For oophorectomy, or their male partners are status post vasectomy, no additional method of contraception is required.\n* Deteriorated renal function, as indicated by a creatinine clearance \\\u003C60 mL\u002Fmin calculated by the Cockcroft-Gault Equation. The calculated creatinine clearance can be confirmed by measured creatinine clearance.\n* Having only one functional kidney, due to potential nephrotoxicity.\n* Patients who have had any prior EBRT dose to either kidney.\n* Deteriorated bone marrow function, as indicated by:\n\n  * Hemoglobin (Hb) \\\u003C 8.0 g\u002FdL\n  * White blood cell (WBC) \\\u003C 2 x10\\^3\u002FuL\n  * Absolute neutrophil count (ANC) \\\u003C 1.0 x 10\\^3\u002FL\n  * Platelets \\\u003C100 x 10\\^3\u002FmicroL\n* Deteriorated liver function, as indicated by one or more of the following:\n\n  * International normalized ratio (INR) \\> 2.0 for patients that are not on Coumadin\n  * Prothrombin time (PTT) \\> 2 x ULN\n  * Total bilirubin \\> 3 mg\u002FdL\n  * Serum albumin \\\u003C 3.0 g\u002FdL unless prothrombin time is within the normal range\n  * Alanine aminotransferase (ALT) \\> 3 x ULN\n  * Aspartate aminotransferase (AST) \\> 3 x ULN.\n* Previous local therapy \\\u003C4 weeks prior to study entry.\n* Extended QTc interval above 480 ms confirmed by 2 ECGs. If the first ECG conducted at the screening visit shows extended QTc interval, potential participants will be asked to repeat an ECG within 30 days to confirm. The second ECG can be conducted at NIH CC or at their outside provider, at their potential expense.\n* Toxicities from prior therapies that have not resolved to grade 1 or grade 0 excluding dry mouth syndrome from previous RAI and grade 2 anemia\u002Fleukopenia as Hgb\\>=8 g\u002Fdl, WBC \\>=2 x10\\^3\u002FuL and ANC \\>= 1.0 x 10\\^3 are acceptable for enrollment.\n* Active and clinically significant bacterial, fungal, or viral infection, including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness. Radiolabeled ligands may affect the immune response, so people with active and clinically significant infections may become too immunocompromised through participation in this study.\n* Known brain metastases and\u002For carcinomatous meningitis unless these metastases have been treated and stabilized.\n* Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Prior external beam radiation therapy involving \\>25% of the bone marrow.\n* Unmanageable urinary incontinence rendering the administration of 177Lu-DOTA-EB-TATE unsafe.\n* Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence.\n* Is unwilling or unable to establish care with a local provider outside of NIH CC\n* Inability to understand or unwilling to sign a written informed consent document.",{"count":150,"type":22},18,[152,102],"PHASE1","Background:\n\nOncocytic (Hurthle cell) thyroid cancer (HTC) is a rare disease with few treatment options. Researchers are developing a radioactive drug that targets a protein that appears in high numbers on HTC cancer cells.\n\nObjective:\n\nTo test a radioactive drug (177LuDOTA-EB-TATE) in people with HTC.\n\nEligibility:\n\nPeople aged 18 years and older with HTC. The HTC must have failed to respond to conventional radioactive treatment; it must also have spread to other parts of the body.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have imaging scans and a test of their heart function.\n\n177LuDOTA-EB-TATE is infused into a vein. Participants will receive 4 infusions spaced 8 to 12 weeks apart. They will stay in the hospital for 4 to 10 days after each infusion. During and after each infusion, participants will remain in a lead-lined room until their radiation levels go down; this usually takes about 24 hours.\n\nParticipants will have 4 to 6 follow-up visits in the weeks after each infusion. Procedures will vary at each visit, but may include more imaging scans; blood and urine tests; and tests of heart function. Participants will have 2 single-photon emission computerized tomography (SPECT) scans. SPECT scans show where the study drug is sticking to tumors or maybe other parts of their body. They will lie on a table while a machine rotates around them. Participants will fill in questionnaires about how their thyroid condition affects their life.\n\nParticipants will have follow-ups visits for 5 years after their last study treatment.",[155],"Thyroid Cancer",[155,157,158],"H(SqrRoot) rthle cell thyroid cancer","177Lu-DOTA-EB-TATE",{"date":34,"type":35},{"date":37,"type":22},{"date":162,"type":22},"2032-08-01",{"name":41,"class":42},{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":180,"leadSponsor":182,"locationsCount":43},"100569134","assessing-the-impact-of-perceptions-of-unpredictability-on-objective-measures-of-food-consumption-and-metabolism-100569134","NCT06690294","Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism","Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism: A Natural History Study","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* 18-60 years of age.\n* Able to read and understand English proficiently (to be able to complete the multiple study questionnaires and instruments).\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Diabetes\n\n  * Fasting glucose \\>= 126 mg\u002Fdl or HbA1c \\>= 6.5% or\n  * Self-reported history of type 1 or type 2 diabetes.\n* Endocrine disorders, such as\n\n  --Self-reported history of Cushing's disease, pituitary disorders, or hypo- and hyperthyroidism\n* TSH \\\u003C0.1 or \\>= 10 uIU\u002FmL\n* Pulmonary disorders\n\n  --Self-reported history of chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol (investigator judgment)\n* Cardiovascular diseases,\n\n  --Self-reported history of coronary heart disease, heart failure, arrhythmias, and peripheral artery disease that which would limit ability to follow the protocol (investigator judgment)\n* Liver disease,\n\n  * Advanced liver disease (as determined by history, labs, exams, and patient self-report) that which would limit ability to follow the protocol (investigator judgment)\n  * AST or ALT elevations \\> 3 times upper limit of normal\n* Gastrointestinal Surgery\n\n  --Self-reported history of bariatric surgery\n* Renal disease\n\n  * Self-reported history of renal replacement therapy\n  * Abnormal kidney function (defined as eGFR \\\u003C60 mL\u002Fmin\u002F1.73m\\^2) determined at screening (eGFR values are computed using the 2021 CKD-epi equation)\n* Central nervous system disease:\n\n  --Including self-reported history of previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders\n* Infectious disease:\n\n  --Self-reported history of active tuberculosis, HIV, chronic coccidiomycosis or other chronic or acute infections\n* For Females: pregnancy, \\\u003C=6 months postpartum, currently breastfeeding, or on birth control (i.e., ingested, injected or implanted; non-hormonal methods such as copper IUD will be allowed)\n* Measured weight: greater than or equal to 450 lb. (maximum weight allowed on the DXA scanning tables by the manufacturer)\n* Inability to provide informed consent.\n* Self-reported history of psychological conditions including (but not limited to), active psychosis, schizophrenia, eating disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study.\n* Current use of medications\u002Fdietary supplements\u002Falternative therapies known to alter energy metabolism.\n* Inability to consume provided food during ad libitum food intake or snack food test based on a food allergy or intolerances or diet restrictions.\n* Any disorder not covered by any other exclusion criteria which, in the investigator's and\u002For team's opinion jeopardizes the safety of the participant or others or would interfere with adherence to the protocol.\n* Alcohol Abuse as defined by \\>= 8-point score on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire will be an exclusion criterion.\n* Current use of tobacco products that exceed \"Very Low Dependence\" on the Fagerstrom Test for Nicotine Dependence Tool (score greater than 2) will be an exclusion criterion.\n\nNon-English-speaking subjects as a population will be excluded from participation in this protocol. Primary and secondary hypotheses of the protocol relate to a battery of psychological questionnaires and performances tests which are administered throughout the study. There are currently no validated, translated forms of these questionnaires and tests available; therefore, we will restrict enrollment to English speaking subjects only.",{"count":172,"type":22},110,"Background:\n\nMany people in the United States are overweight or obese. This natural history study will look into how life events during childhood can impact eating behaviors and weight gain as adults.\n\nObjective:\n\nTo explore how childhood experiences affect adult eating behaviors.\n\nEligibility:\n\nHealthy people aged 18 to 60 years.\n\nDesign:\n\nParticipants will have 3 clinic visits.\n\nThey will be screened with blood tests. They will answer questions about their alcohol and tobacco use.\n\nAt the next visit, participants will undergo these activities:\n\nParts of their body (such as waist, neck, and thighs) will be measured with a tape.\n\nThey will have an imaging scan to find out how much body fat they have.\n\nThey will start wearing a device like a wristwatch that measures their physical activity. They will wear this device for up to 10 days.\n\nThey will wear a device on their upper arm or belly that measures blood glucose (sugar) levels. Participants will wear this for 7-10 days.\n\nThey will answer questions about their education, childhood, and routines.\n\nThey will receive a kit to collect a stool sample at home.\n\nAt the last visit, participants will have these tests:\n\nParticipants will relax and breathe normally while wearing a clear, plastic canopy that fits over their entire head.\n\nBlood samples will be taken before and after participants drink a sugary drink.\n\nParticipants will be offered a large selection of foods for lunch. They will eat as much as they want. Then they will answer questions about how they feel about food and themselves.",[26,175],"Obestity",[26,79,177],"Eating Behavior",{"date":34,"type":35},{"date":37,"type":22},{"date":181,"type":22},"2027-01-30",{"name":41,"class":42},{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":17,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":203,"leadSponsor":205,"locationsCount":43},"100494748","prevalence-and-development-of-liver-dysfunction-in-hematopoietic-stem-cell-transplant-100494748","NCT05722210","Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant","Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant: A Prospective Natural History Study","* INCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be included in this study:\n\n* Male and female adults \\>=18 years of age and children 3-17 years of age\n* Undergoing evaluation for hematopoietic stem cell transplant at the NIH Clinical Center\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this\n\nstudy:\n\n* Pregnancy or lactation\n* Unable to comply with study procedures\n* Inability to provide written informed consent","3 Years","90 Years",{"count":193,"type":22},500,"Background:\n\nHematopoietic stem cell transplant (HSCT) is a common treatment for many cancers and other illnesses. But many people who have HSCT go on to develop liver dysfunction. Researchers want to know more about how and why this happens. In this natural history study, they will try to learn what factors lead to liver dysfunction; how underlying liver disease may affect the results of HSCT; and how HSCT may contribute to liver dysfunction.\n\nObjective:\n\nTo understand the links between HSCT and liver dysfunction.\n\nEligibility:\n\nAdults aged 18 years or older and children 3 to 17 years who are being evaluated for HSCT.\n\nDesign:\n\nThis study involves 11 visits in 4 years. Most visits will be in the first year.\n\nBefore and after their HSCT, participants will undergo these tests:\n\nPhysical exam, including blood tests and a test of heart function. Participants will provide stool samples.\n\nLiver biopsies. Samples of liver tissue will be removed. This may be done either by inserting a needle through the right side of the chest, or with a thin tube threaded to the liver from a vein in the neck. Adult participants will undergo this procedure 2 times: once before the HSCT and once about a year later.\n\nImaging scans. Participants will lie on a bed that moves into either a cylinder or a donut-shaped machine.\n\nUltrasound. Participants will lie still. A probe that uses sound waves will be slid over their skin to get pictures of the liver.\n\nFibroscan exam. This is like an ultrasound that uses a special probe to measure the toughness of the liver.\n\n...",[196],"Hematopoietic Stem Cell Transplant",[198,199,200],"Liver Disease","Liver Dysfunction","Natural History",{"date":34,"type":35},{"date":37,"type":22},{"date":204,"type":22},"2031-06-30",{"name":41,"class":42},{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":213,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":214,"targetDuration":4,"studyType":100,"phases":216,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":225,"leadSponsor":227,"locationsCount":43},"100494101","trial-of-the-combination-of-alpha-lipoic-acid-and-mirabegron-in-women-and-in-men-with-obesity-100494101","NCT05713799","Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity","Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity","* INCLUSION CRITERIA\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Adults 18 to 65 years of age\n2. BMI greater than or equal to 30 kg\u002Fm\\^2 and less than or equal to 45 kg\u002Fm\\^2\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Hypersensitivity and associated allergic reactions to mirabegron or alpha-lipoic acid (or similar drug substances or components).\n2. Abnormal bladder function, diagnosis of bladder outlet obstruction, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB).\n3. Type 1 diabetes mellitus; type 2 diabetes mellitus; or any person taking exogenous insulin therapy or any medication that is a hypoglycemic agent. (type 1 or Type 2 Diabetes mellitus, fasting serum glucose \\>125 mg\u002FdL, and\u002For an HbA1c test \\>6.5%).\n4. Elevated resting blood pressure \\>140\u002F90 mmHg.\n5. Individuals with eGFR \\\u003C60 ml\u002Fmin\u002F1.72 m\\^2 and a urinary albumin\u002Fcreatinine ratio UACR\\>300 mg\u002Fg.\n6. Hypo- or hyper-thyroid disease (TSH \\>5.0, or \\\u003C0.4 MIU\u002FL) that is controlled for less than one year or someone currently taking thyroid hormone replacement.\n7. Anemia, defined by hemoglobin \\\u003C11.5 g\u002FdL (females) or \\\u003C13.5 g\u002FdL (males); sickle cell anemia or other blood disorders; and\u002For wound healing problems.\n8. Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment.\n9. A clinically significant abnormal ECG and\u002For QTc interval above normal\n10. Moderate hepatic impairment (Child-Pugh Class B) or above\n11. Elevated liver enzymes \\>75 U\u002FL (ALT or AST)\n12. Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics\n13. Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months.\n14. Individuals that have been on a very low-calorie diet (\\\u003C800 kcal\u002Fd), self-reported weight loss \\>5% in the preceding six months, or those taking weight loss medications.\n15. History of seizure disorder.\n16. Addiction to alcohol or substances of abuse within the last 5 years.\n17. Self-reported current alcohol consumption of more than 2 servings of alcohol per day.\n18. Self-reported current use of nicotine and\u002For tobacco products.\n19. Current use of any drugs known to:\n\n    1. Have major drug-drug interactions with mirabegron or alpha-lipoic acid\n    2. Be CYP2D6 substrates\n    3. Prolong QT interval\n    4. Alter glucose metabolism or cause insulin resistance (in last six months)\n    5. Treat diabetes mellitus\n    6. Treat hypertension\n    7. Be drugs of abuse\n20. Inability to provide informed consent.\n21. Unwilling or unable to eat metabolic meals, as determined by dietitian consult.\n22. Individuals with significant medical comorbidities or other factors that would render the individual s participation unsafe or affect the outcome of the study as assessed by the investigator.",true,{"count":215,"type":22},60,[102],"Background:\n\nObesity and related illnesses cause at least 2.8 million deaths each year worldwide. Few treatments exist for obesity that are safe and widely available. A study drug (mirabegron \\[MG\\]) combined with a supplement (alpha-lipoic acid \\[ALA\\]) may help.\n\nObjective:\n\nTo learn how MG and ALA can help the body process food.\n\nEligibility:\n\nPeople aged 18 to 65 years with a body mass index between 30 and 45 kg\u002Fm2.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam. They will have blood and urine tests and a test of their heart function. They will speak with a dietician.\n\nThe study has two phases. Each phase begins with a 2-day stay in the clinic; then the participant will take the study drugs at home for about 4 weeks, followed by another 2-day stay in the clinic. They will also have outpatient visits about 2 weeks after each clinic stay.\n\nDuring the clinic stays, participants will undergo many tests:\n\nThey will have a plastic tube (catheter) inserted into a vein in each arm. These will be used to draw blood and to infuse glucose (sugar) and insulin.\n\nThey will have imaging scans.\n\nThey will have a clear hard plastic shield placed over their head to measure oxygen and carbon dioxide as they breathe.\n\nParticipants will take the study drugs at home. Both MG and ALA are taken by mouth with water. During one phase, participants will take MG plus a placebo. A placebo looks like the study drug but doesn t contain medicine....",[219,79],"Insulin Resistance",[79,221,219,222],"Insulin Sensitivity","Placebo",{"date":34,"type":35},{"date":37,"type":22},{"date":226,"type":22},"2030-03-01",{"name":41,"class":42},{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":213,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":43},"100272756","evaluation-of-adults-with-endocrine-and-metabolic-related-conditions-100272756","NCT02830308","Evaluation of Adults With Endocrine and Metabolic-Related Conditions","Evaluation of Adults With Endocrine-Related Conditions","* INCLUSION CRITERIA:\n* Participants with known or suspected endocrine disorder age 18 years and older are eligible for this protocol. Protocol investigators will make the actual selection of subjects most appropriate for clinical evaluation.\n* Relatives ages 18 years and older may be enrolled if clinically indicated for the diagnosis of a proband.\n\nEXCLUSION CRITERIA:\n\n* Anyone under the age of 18 years old\n* Any medical, physical, psychiatric, or social conditions, which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the subject. Subjects who are critically ill, unstable, or with severe organ failure that may affect\u002Flimit the endocrine evaluation and place unsustainable demands on Clinical Center or NIDDK resources.",{"count":236,"type":22},1250,"Background:\n\nThere are many endocrine and metabolic-related conditions. Two well-known disorders include diabetes and thyroid disease. Some of these diseases are caused by a change in genes. Researchers want to identify the genes involved in these disorders. They hope this will help them learn more about these diseases.\n\nObjectives:\n\nTo learn more about conditions that affect the hormone-secreting glands (endocrine glands) in adults. To train doctors to diagnose and treat people with endocrine or metabolic conditions.\n\nEligibility:\n\nAdults age 18 years and older with a known or suspected endocrine disorder.\n\nRelatives ages 18 years and older.\n\nDoctors will review all requests and available medical records to determine final eligibility for the protocol.\n\nDesign:\n\nParticipants will have a medical history and physical exam.\n\nMost participants will have 1 visit, and may have follow up visits if necessary. They may have tests, surgery, or other procedures to help diagnose or treat their condition. These could include:\n\n* Blood, urine, and saliva tests\n* Imaging tests. These may include X-ray, ultrasound, or scans.\n* Sleep study\n* Medical photographs\n* Visits with other specialists at NIH\n\nParticipants will provide blood, urine, saliva, or tissue samples. Some of these samples may be stored in the freezer for future studies.\n\nParticipants may be asked to participate in genetic testing. They will give a blood or saliva sample for this.",[239],"Endocrine Diseases",[241,242,243,244,245,200],"Hormones","Endocrine","Hypercortisolism","Bone","Hypothalamic-Pituitary Dysfunction",{"date":34,"type":35},{"date":248,"type":35},"2016-07-09",{"date":250,"type":22},"2029-12-31",{"name":41,"class":42},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":17,"minAge":259,"maxAge":191,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":4,"leadSponsor":272,"locationsCount":43},"100141243","clinical-and-genetic-studies-in-familial-non-medullary-thyroid-cancer-100141243","NCT01109420","Clinical and Genetic Studies in Familial Non-medullary Thyroid Cancer","Clinical and Genetic Studies in Familial Non-Medullary Thyroid Cancer","* INCLUSION CRITERIA:\n\nSubjects will be selected for this protocol based on either a clinical diagnosis of non-medullary thyroid cancer and the presence of one family member with the disease or the presence of 2 living family members with this disease. Patient selection for this protocol will not be based on gender, race, or ethnic background.\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Adults or minor (\\>= 7 years+), males and females.\n* An unaffected individual with (Bullet) 2 first-degree relatives who have or have had nonmedullary thyroid cancer\n\nOR\n\n-An affected individual with documented diagnosis of non-medullary thyroid cancer and (Bullet) one living relative with documented non-medullary thyroid cancer (Note: as this is a familial study, subjects do not need to present with the disease)\n\nOR\n\n* Any member of an affected family. (Note: for this study, an affected family is defined as a family having 2 or more 1st degree relatives with a documented diagnosis of FNMTC.)\n* Adults must be able to understand and the willingness to sign the informed consent document.\n* Adults must be able to complete the family history questionnaire.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be not be allowed to enroll in this study:\n\n-Subjects unwilling\u002Funable to give informed consent.","7 Years",{"count":193,"type":22},"Background:\n\n\\- Researchers are studying types of thyroid cancer that seem to cluster in families. Non-medullary thyroid cancer accounts for the vast majority of all types of thyroid cancer, but little is known about possible genes that may cause the cancer. More research is needed to develop the best ways to screen for familial non-medullary thyroid cancer (FNMTC) so that it can be diagnosed and treated at an early stage.\n\nObjectives:\n\n* To evaluate the natural history of FNMTC.\n* To determine the best screening strategy for FNMTC.\n* To identify genes that may indicate susceptibility to FNMTC.\n\nEligibility:\n\n\\- Individuals at least 7 years of age who have two first-degree relatives (e.g., parents, children, siblings) who have or have had non-medullary thyroid cancer or a documented diagnosis of non-medullary thyroid cancer and one living relative with documented non-medullary thyroid cancer.\n\nDesign:\n\n* Participants will be evaluated by family history pedigree, physical examination, imaging (including possible neck ultrasound and radioactive iodine scans), and laboratory testing.\n* Participants who agree to have blood or other biological samples collected will be asked to enroll in an additional study to provide the appropriate samples and tissues.\n* After the initial study evaluation, participants who are not found to have a malignant thyroid tumor will be re-screened every year with non-invasive imaging studies. Participants who are found to have a malignant thyroid tumor will be informed of possible treatment options.",[263],"Non-Medullary Thyroid Cancer",[265,266,267,200],"Hereditary Cancer","Susceptibility Gene(s) for Thyroid Cancer","Screening at Risk Family Members","2026-08-19",{"date":32,"type":35},{"date":271,"type":35},"2010-08-12",{"name":41,"class":42},{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":98,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":282,"conditions":283,"keywords":286,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":4,"leadSponsor":290,"locationsCount":43},"100054339","diagnosing-and-treating-low-blood-sugar-levels-100054339","NCT00001276","Diagnosing and Treating Low Blood Sugar Levels","Fasting Hypoglycemia: Diagnosis and Treatment","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male, females ages \\>= 18.\n2. Patients with documented fasting blood glucose below 55 mg\u002Fdl.\n\n4\\. Patients with biochemical evidence for insulinoma or other pancreatic neuroendocrine tumors.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Patients with significant cardiac disease will be excluded.\n2. Subjects who are pregnant per self-report.\n3. Medically unstable per the assessment of the PI.",{"count":281,"type":22},1500,"Hypoglycemia is the term used to refer to lower than normal levels of blood sugar. This study will continue to research the causes of hypoglycemia.\n\nPatients involved in the study will be admitted to the Clinical Center of the National Institutes of Health and undergo tests for evaluating blood sugar. Patients will be required to refrain from eating for a set period of time and will undergo blood tests for insulin levels and several other specific diagnostic tests related to insulin secretion. The patients will be under supervision and will be provided with appropriate medical and surgical attention as needed.",[284,285],"Hypoglycemia","Insulinoma",[284,285,200],{"date":32,"type":35},{"date":289,"type":35},"1991-05-21",{"name":41,"class":42},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":17,"minAge":298,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":302,"conditions":303,"keywords":308,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":4,"leadSponsor":315,"locationsCount":43},"100054237","studies-on-tumors-of-the-thyroid-100054237","NCT00001160","Studies on Tumors of the Thyroid","Studies on Thyroid Nodules and Thyroid Cancer","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female, adults or children \\>= 6 months+.\n2. Patients with known or suspected thyroid nodules and\u002For thyroid cancer.\n3. At risk family members of patients who have a genetic susceptibility to developing thyroid cancer.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma requiring intervention before thyroid cancer is addressed.","6 Months","98 Years",{"count":301,"type":22},2500,"Participants in this study will be patients diagnosed with or suspected to have a thyroid nodule or thyroid cancer.\n\nThe main purpose of this study is to further understand the methods for the diagnosis and treatment of thyroid nodules and thyroid cancer. Many of the test performed are in the context of standard medical care that is offered to all patients with thyroid nodules or thyroid cancer. Other tests are performed for research purposes. In addition, blood and tissue samples will be taken for research and genetic studies.",[304,305,306,155,307],"Hurthle Cell Thyroid Cancer","Tall Cell Variant Thyroid Cancer","Follicular Thyroid Cancer","Papillary Thyroid Cancer",[309,310,311,200],"Thyroid Fine Needle Biopsy","Radioiodine","Dosimetry",{"date":32,"type":35},{"date":314,"type":35},"1977-06-01",{"name":41,"class":42},{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":17,"minAge":298,"maxAge":299,"enrollmentInfo":322,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":323,"conditions":324,"keywords":328,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":4,"leadSponsor":333,"locationsCount":43},"100054236","natural-history-of-thyroid-function-disorders-100054236","NCT00001159","Natural History of Thyroid Function Disorders","* INCLUSION CRITERIA:\n\nThe categories of subjects eligible to participate in this study include:\n\n1. Patients with known or suspected thyroid abnormalities (e.g. hypothyroidism, hyperthyroidism, extreme iodine deficiency, and inherited forms of hypothyroidism resulting from abnormalities in the expression of genes coding for the TSH- beta subunit, Pax-8, TTF-2, Pit-I, Tg, PDS, and NIS.\n2. Patients with thyroid function test (TFT) abnormalities due to:\n\n   * Non-thyroidal illness\n   * Abnormalities of serum TH binding proteins leading to euthyroid hyperthyroxinemia or hypotriiodothyronemia.\n   * Genetic deficiency of thyroxine-binding globulin (TBG).\n   * Antibodies to mouse immunoglobulins leading to an artifactual elevation in the TSH ultrasensitive (\"3rd generation\") assay which may mimic \"inappropriate\" secretion of TSH.\n\nInclusion and exclusion criteria for each group of subjects are given below.\n\nPatients with known or suspected thyroid abnormalities will be eligible to p rticipate if the individual meets all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study.\n2. Male or female, aged 6 months+.\n\nHyperthyroid states include but are not restricted to:\n\n1. Graves' disease (GD) thought to result from thyroid-stimulating immunoglobulins (TSIg's), a subclass of which also stimulate eye muscle and fatty tissue producing exophthalmos (Graves' ophthalmopathy), as well as the skin in the pretibial area causing pretibial myxedema (Graves' dermopathy);\n2. Subacute thyroiditis (SAT), a painful inflammation thought to result from viral infection with Coxsackie, as well as other viruses;\n3. Silent thyroiditis, a painless inflammation thought to result from autoimmune attack of thyrocytes by antimicrosomal antibodies directed against thyroid peroxidase (TPO), as well as antithyroglobulin(anti-Tg) antibodies;\n4. Single or multiple hyperfunctioning thyroid nodules of unknown etiology, probably resulting from the activation of certain thyroid oncogenes and\u002For growth factors, such as the thyrotropin (TSH) receptor (TSHR) and the a-subunit of the G protein (Ga);\n5. Iodide-induced hyperthyroidism of unknown etiology;\n6. Surreptitious administration of thyroid hormone (TH), usually present in patients with underlying psychiatric disease or occasionally related to patients with obesity and other eating disorders\n7. Trophoblastic neoplasms, thought to result from high levels of hCG secretion, which, because of its structural similarity to TSH, causes \"spillover\" of action at the TSHR level;\n8. \"Inappropriate\" secretion of TSH, which may be present either in patients with TSH- producing pituitary tumors (TSHomas) or from a non-neoplastic cause, i.e. pituitary resistance to the action of thyroid hormone (3,4).\n\nHypothyroid states include but are not restricted to:\n\n1. Primary (or thyroidal) hypothyroidism, usually resulting from auto-antibodies to thyroid proteins, such as antimicrosomal antibodies to TPO usually associated with lymphocytic (Hashimoto's) thyroiditis (HT) or atrophic thyroiditis, or blocking antibodies to the TSHR, usually in the context of non-goitrous hypothyroidism;\n2. Secondary (or pituitary) hypothyroidism, usually resulting from tumors of the pituitary of non-thyrotropic origin such, as growth hormone (GH)-secreting tumors or prolactinomas;\n3. Tertiary (or hypothalamic) hypothyroidism, usually resulting from a deficiency in the hypothalamic hormone thyrotropin-releasing hormone (TRH), either of unknown etiology or secondary to a pituitary tumor;\n4. Bio-inactive TSH, either relating to an endogenous abnormality of hypothalamic hormones or secondary to pituitary tumors (and usually related to abnormal glycosylation patterns of the TSH molecule);\n5. Generalized resistance to thyroid hormone (RTH), a disease which has been shown to be due to abnormalities in the TH receptor, c-erbA-beta (or TR- beta).\n\nThe above are the principal disorders under study, but we may also investigate other abnormalities, such as extreme iodine deficiency, and inherited forms of hypothyroidism resulting from abnormalities in the expression of genes coding for the TSH- beta subunit, Pax-8, TTF-2, Pit-I, Tg, PDS, and NIS (among others).\n\nEXCLUSION CRITERIA:\n\nThere are no exclusion criteria for subjects with known or suspected thyroid abnormalities.",{"count":301,"type":22},"Participants in this study will be patients diagnosed with or suspected to have a thyroid function disorder. These conditions may include: hypothyroidism, hyperthyroidism, thyroid hormone resistance, Graves' Dermopathy, and thyroid-stimulating hormone (TSH) secreting pituitary adenomas.\n\nThe main purpose of this study is to further understand the natural history, clinical presentation, and genetics of thyroid function disorders. Many of the tests performed are in the context of standard medical care that is offered to all patients with thyroid function disorders. In addition, blood and tissue samples may be taken for research and genetic studies.",[325,326,327],"Hyperthyroidism","Hypothyroidism","Grave's Disease",[325,326,327,200,329],"Thyroid-Stimulating Hormone Secreting Pituitary Ad",{"date":32,"type":35},{"date":332,"type":35},"1977-02-01",{"name":41,"class":42},{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":213,"sex":17,"minAge":340,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":344,"conditions":345,"keywords":349,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":43},"100469897","a-natural-history-study-of-metabolic-sizing-in-health-and-disease-100469897","NCT05398783","A Natural History Study of Metabolic Sizing in Health and Disease","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all the following criteria for their cohort:\n\nCohort 1 - Healthy Volunteers\n\n* Male or female, aged \\>=2 years\n* In good general health as evidenced by medical history\n\nCohort 2 - Patients\n\n* Male or female, aged \\>=2 years\n* Diagnosed with diseases thought to alter metabolism or body composition (such as weight loss or gain, diabetes, renal disease, obesity, cancer, etc.) or taking medications thought to alter metabolism or body composition.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Participants over 200 kg due to the weight limit of the equipment.\n* Presence of any implanted device that would interfere with measurements.\n* Any moderate to severe limitations in mobility that would impede participation\n* Hemoglobin less than 10 g\u002FdL (in participants who would have blood drawn for research purposes).\n* Participants with dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.\n* Participants unwilling or unable to give informed consent.\n* Participants with any other significant physical, medical, or psychiatric limitations, illness or conditions that may preclude them from completing the majority of the tests in this study per the discretion of the PI.","2 Years","99 Years",{"count":343,"type":22},2000,"Background:\n\nScientists have long used simple measures (such as height and weight) to estimate how much a person s body uses food (calories) as energy, as commonly called the metabolic rate. But metabolism varies among people with similar body sizes. Scientists now believe the old formulas for estimating metabolic rates may not work well for all people. Researchers want to find more accurate ways to measure a person s metabolism.\n\nObjective:\n\nThis natural history study will examine the relationships between metabolism, body composition, and body surface area in a wide range of people.\n\nEligibility:\n\nHealthy children and adults aged 2 years or older. Also, people aged 2 years or older with conditions that may alter metabolism. These may include diabetes, obesity, renal disease, or cancer.\n\nDesign:\n\nParticipants will spend 2 days and 1 night in the hospital. They will provide a medical history and answer questions about their activity levels, the foods they eat, and their lifestyle. They will also eat a special diet.\n\nParticipants will undergo many tests:\n\nThey will lie in a bed with a clear hood covering their head for 30 to 45 minutes to measure the gases in their breath.\n\nThey will lie on a padded table for about 15 minutes while their body is scanned.\n\nThey will stand on a platform while a 3D scanner measures their body.\n\nThey will have a test to measure how fast an electric signal moves through their body.\n\nThey will grip an instrument to measure the strength of their hands.\n\nThey will drink salty water and provide blood and urine samples.\n\nParticipants may be invited to return for these 2-day visits up to 8 times per year. Return visits must be at least 2 weeks apart.",[81,346,347,80,348],"Cancer","Chronic Kidney Disease","Normal Physiology",[350,351,352,200],"Body Composition","Metabolism","Body Surface Area","2026-08-18",{"date":268,"type":35},{"date":356,"type":35},"2022-10-25",{"date":358,"type":22},"2031-07-01",{"name":41,"class":42},{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":366,"enrollmentInfo":367,"targetDuration":4,"studyType":100,"phases":368,"briefSummary":369,"conditions":370,"keywords":372,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":43},"100289569","phase-1-the-physiological-responses-and-adaptation-of-brown-adipose-tissue-to-chronic-treatment-with-beta3-adrenergic-receptor-agonists-100289569","NCT03049462","The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nCohort 1: (complete)\n\n1. Female\n2. Age 18-40 years\n3. BMI 18.00-40.0 kg\u002Fm\\^2\n4. Able to understand the research and willing to sign a written informed consent document\n\nCohort 2: (complete)\n\n1. Male\n2. Age 18-40 years\n3. BMI 18.00-40.0 kg\u002Fm\\^2\n4. Able to understand the research and willing to sign a written informed consent document\n\nCohort 3:\n\n1. Female\n2. Age 18-40 years\n3. BMI 25.0-50.0 kg\u002Fm\\^2 or BMI \\> 18.5 kg\u002Fm\\^2 with PCOS diagnosis\n4. Diagnosis of PCOS based on NIH Criteria; defined by the presence of both clinical and\u002For biochemical signs of hyperandrogenism and oligo- or chronic anovulation.\n5. Women of childbearing potential must agree to use a highly effective method of birth control, confirmed by the Investigator, for at least 3 months prior to the first study visit and continuing throughout the study duration.\n\n   a. Highly effective methods of birth control include:\n\n   i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal\n\n   ii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable\n\n   iii. Intrauterine device\n\n   iv. Intrauterine hormone-releasing system\n\n   v. Bilateral tubal occlusion\n\n   vi. Sexual abstinence, i.e., refraining from heterosexual intercourse (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant)\n\n   vii. Vasectomized sexual partner (provided that partner is the sole sexual partner of the study participant and that the vasectomized partner has received medical assessment of the surgical success)\n\n   b. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for \\>=12 months prior to the planned date of enrollment without an alternative medical cause.\n6. Insulin resistance defined by either\n\n   1. HOMA-IR score \\> 5.9 OR\n   2. HOMA-IR score \\> 2.8 and \\\u003C5.9, with HDL \\\u003C51 mg\u002FdL OR\n   3. Fasting Insulin \\> 10.6 microU\u002FmL\n7. Able to understand the research and willing to sign a written informed consent document\n\nEXCLUSION CRITERIA\n\n1. Hypersensitivity and associated allergic reactions to mirabegron (or similar drug substances or components)\n2. Abnormal bladder function, diagnosis of bladder outlet obstruction, urinary incontinence, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB)\n3. Type 1 or Type 2 Diabetes mellitus, fasting serum glucose \\>125 mg\u002FdL, and\u002For an HbA1c test \\>6.5%\n4. Hypertension, defined as blood pressure (Bullet)140\u002F90 mmHg, based on WHO guidelines (https:\u002F\u002Fwww.who.int\u002Fnews-room\u002Ffact-sheets\u002Fdetail\u002Fhypertension)\n5. Hypo- or hyper-thyroid disease (TSH \\>5.0, \\\u003C0.4 miU\u002FL) that is controlled for less than one year\n6. Anemia, defined by hemoglobin \\\u003C 11.3 g\u002FdL (females) or \\\u003C 13.8 g\u002FdL (males); sickle cell anemia or other blood disorders; and\u002For wound healing problems\n7. Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment\n8. A clinically significant abnormal ECG and\u002For QTc interval above normal\n9. Elevated liver enzymes with probable or diagnosed liver disease (other than fatty liver disease)\n10. Psychological conditions such as claustrophobia, untreated clinical depression or anxiety, untreated bipolar disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study\n11. Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics\n12. Self-reported intolerance of cold that would prevent the individual from spending several hours in a chilled room with a cooling vest\n13. Current use of any drugs known to:\n\n    * have major drug-drug interactions with mirabegron\n    * Prolong QT interval\n    * Alter glucose metabolism or cause insulin resistance (in last six months)\n    * Treat diabetes mellitus\n    * Treat hypertension\n    * Be drugs of abuse\n14. Self-reported weight loss or weight gain \\> 5% in the preceding 6 months.\n15. Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months\n16. Individuals who spend \\>70% of daily hours outdoors since the exposure to varied environmental temperatures will potentially impact the ability to influence and measure BAT activity.\n17. Addiction to alcohol or substances of abuse within the last 5 years\n18. Self-reported current alcohol consumption of more than 2 servings of alcohol per day\n19. Self-reported current use of nicotine and\u002For tobacco products\n20. Has participated in a clinical trial with an investigational or marketed drug within 2 months\n21. Have had previous radiation exposure (X-rays, PET scans, etc.) within the last year or anticipate radiation exposure in the upcoming year - clinical and\u002For research - that would exceed research limits\n22. Donated blood within last 2 months\n23. Unwilling or unable to eat metabolic meals, as determined by dietitian consult.\n24. Any other circumstances or criteria that would preclude safe participation in the study in the clinical judgment of the investigator","40 Years",{"count":52,"type":22},[152],"Background:\n\nBrown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy.\n\nObjective:\n\nTo learn more about how BAT works to burn energy.\n\nEligibility:\n\nPeople ages 18-40 with a body mass index between 18 and 40\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood, urine, and heart tests\n\nDietitian interview\n\nParticipants will have an overnight baseline visit. This includes:\n\nRepeats of screening tests\n\nExercise test\n\nScans. For one scan, a radioactive substance is injected into the arm.\n\nFSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are injected in one arm. Blood glucose and insulin levels are measured from the other.\n\nMetabolic suite: Participants stay 18-19 hours in a room that measures their metabolic rate. Monitors on the body measure heart rate, movement, and temperature.\n\nOptional fat biopsy: A small piece of tissue is removed with a needle.\n\nParticipants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron. Men will be randomly get either the drug or a placebo.\n\nAll participants will have a visit after 2 weeks of the pills. They will repeat the screening tests.\n\nParticipants will have an overnight visit 2 weeks later. They will repeat the baseline tests.\n\nParticipants will keep food and medication diaries.\n\nParticipants will have a follow-up visit 2 weeks after stopping the pills. This includes heart tests.",[371],"Polycystic Ovary Syndrome",[373,29,374,79],"Brown Adipose Tissue","Energy Metabolism",{"date":268,"type":35},{"date":377,"type":35},"2017-03-13",{"date":379,"type":22},"2026-09-30",{"name":41,"class":42},{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":213,"sex":17,"minAge":18,"maxAge":341,"enrollmentInfo":387,"targetDuration":4,"studyType":100,"phases":389,"briefSummary":391,"conditions":392,"keywords":393,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":43},"100533264","variability-in-mixed-meal-tests-fixed-versus-adjusted-to-energy-needs-caloric-dose-100533264","NCT06223555","Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Provision of signed and dated informed consent form.\n* Agreement to adhere to Lifestyle Considerations throughout study duration.\n* Males and females; Age \\>= 18years\n* Healthy, as determined by medical history, physical examination, and laboratory tests.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this\n\nstudy:\n\n* Current use of medications, dietary supplements, or alternative therapies known to alter energy metabolism.\n* Fasting plasma glucose \\>= 126 mg\u002FdL\n* Type I or Type II Diabetes Mellitus by self-report.\n* Hematologic disorders including significant anemia (male hemoglobin \\\u003C 13.0 g\u002FdL or female hemoglobin \\\u003C 11.0 g\u002FdL)\n* Current pregnancy, pregnancy within the past 6 months or currently lactating\n* History or self-report of gastrointestinal disease, including inflammatory bowel diseases (e.g. Chron s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) which may alter metabolism or absorption of study food by self-report\n* Evidence of alcohol abuse as defined by an 8-point score on the Alcohol consumption screening AUDIT questionnaire in adults.\n* Participants who report taking large doses of acetaminophen (\\> 3 grams daily) who cannot stop acetaminophen 24 hours prior to and following the meal tests will be excluded from the study.\n* Inability to consume provided food based on a food allergy or intolerance.\n* Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators.\n* Any disorder, unwillingness, or inability not covered by any other exclusion criteria which, in the investigator s and\u002For team s opinion, jeopardizes the safety of the participant or others or would interfere with adherence to the protocol (such as claustrophobia).\n\nConditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators.",{"count":388,"type":22},79,[390],"NA","Background:\n\nResearchers use mixed meal tolerance tests (MMTTs) to look at how people s bodies respond to eating a meal. However, researchers do not agree on how to decide the number of calories to give in each meal. Some use fixed meals, which are the same size for everyone, and some use adjusted meals, based on the size of the person s body. Researchers want to know which MMTT is best to use for future research.\n\nObjective:\n\nTo learn how fixed vs adjusted meals affect blood glucose levels in healthy people.\n\nEligibility:\n\nHealthy people aged 18 years or older.\n\nDesign:\n\nParticipants will have 3 or 4 clinic visits of up to 8 hours in 8 weeks.\n\nParticipants will have baseline tests:\n\nTheir height, weight, and waist size will be measured.\n\nThey will have an oral glucose tolerance test: A needle attached to a tube (IV) will be inserted into a vein in the arm. They will have a sugary drink. Blood samples will be taken from the tube at intervals up to 3 hours after the drink.\n\nThey will have a body scan.\n\nParticipants will have 2 MMTT visits. One will include a fixed meal and one will include an adjusted meal. They will have tests at both visits:\n\nResting metabolic rate: A clear hood will be placed over the participant s head while they rest for 20 minutes. This will measure the oxygen they breathe in and out.\n\nMMTT. Participants will have 5 minutes to drink a liquid meal. Blood samples will be taken at intervals for the next 4 hours....",[79,26],[26,79,350,394,395,396],"Diet","Mixed Meal Test","Glucose","2026-08-15",{"date":353,"type":35},{"date":400,"type":35},"2024-08-23",{"date":402,"type":22},"2027-12-31",{"name":41,"class":42},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":411,"targetDuration":4,"studyType":100,"phases":413,"briefSummary":414,"conditions":415,"keywords":417,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":43},"100523185","phase-2-vir-2218-and-peginterferon-alfa-2a-for-chronic-hepatitis-b-100523185","NCT06092333","VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B","A Pilot Study of the Combination of VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age \\>=18-65 years\n2. HBsAg positive with a level \\\u003C2,000 IU\u002FmL at the time of screening\n3. Hepatitis B e antigen negative\n4. HBV DNA levels \\\u003C10,000 IU\u002FmL on two occasions at least 24 weeks apart with the second being at time of screening\n5. ALT level \\\u003C=2 ULN (using sex-specific cut-offs of normal 35 U\u002FL for males and 25 U\u002FL for females) based on at least two determinations taken at least 24 weeks apart with the second being at time of screening\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnancy or lactation\n2. For women of childbearing potential, inability, or unwillingness to use highly effective contraception during study drug dosing and for an additional 24 weeks after the end of study drug administration.\n3. For males of reproductive potential: Unable or unwilling to use condoms consistently in addition to female partner using another adequate contraceptive method to ensure effective contraception with partner during study participation and for an additional 24 weeks after the end of study medication administration. Patients who have underwent surgical sterilization (vasectomy) will still require female partner to utilize an additional adequate contraception method.\n4. Known history of hypersensitivity or contraindication to an siRNA, oligonucleotide, or GalNAc or any interferon product\n5. Current use of oral theophylline and methadone\n6. Any treatment for HBV within the last 24 weeks\n7. Prior exposure to a siRNA\n8. Co-infection with HDV as defined by the presence of anti-HDV in serum.\n9. Co-infection with HCV as defined by the presence of anti-HCV and HCV RNA in serum.\n10. Co-infection with HIV as defined by the presence of anti-HIV in serum\n11. Cirrhosis either diagnosed by a prior liver biopsy at any time or, if not available, by a transient elastography score \\>13 kPa\n12. Decompensated liver disease as defined by serum bilirubin \\>2.5 mg\u002FdL (with direct bilirubin \\> 1.5 mg\u002FdL), prothrombin time of greater than 2 seconds prolonged, a serum albumin of less than 3.5 g\u002FdL, or a history of ascites, variceal bleeding or hepatic encephalopathy\n13. Hepatocellular carcinoma (HCC), or the presence of a mass on imaging studies of the liver that is suggestive of HCC, or an alpha-fetoprotein level of greater than 500 ng\u002FmL\n14. Presence of other causes of liver disease, (i.e. hemochromatosis, Wilson disease, alcoholic liver disease, severe steatosis, alpha-1-anti-trypsin deficiency)\n15. A history of solid organ or bone marrow transplant\n16. Any current medical condition requiring the chronic use of more than 10 mg of prednisone (or its equivalent) daily or biologics (e.g. monoclonal antibody, interferon) within 3 months of screening.\n17. Significant systemic illness other than liver diseases including congestive heart failure, renal failure, chronic pancreatitis and diabetes mellitus with poor control (hemoglobin A 1C (HgbA1C \\>8.5)), that in the opinion of the investigator may interfere with therapy.\n18. eGFR \\\u003C 60 ml\u002Fmin, serum creatinine \\> 1.3 mg\u002Fdl\n19. Platelet count \\\u003C90 mm\\^3\u002FdL\n20. Hgb \\\u003C12 g\u002FdL for males and \\\u003C11 g\u002FdL for females\n21. White Blood cell count \\\u003C 2500 cells\u002Fmm\\^3\n22. Neutrophil count \\\u003C 1500 cell\u002Fmm\\^3 (or \\\u003C 1000 cell\u002Fmm\\^3 if considered a physiological variant in a subject of African descent)\n23. Active ethanol\u002Fdrug abuse\u002Fpsychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator's opinion, might interfere with participation in the study.\n24. History of malignancy or treatment for a malignancy within the past 3 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin).\n25. History of immune-mediated disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis, sarcoidosis, psoriasis of greater than mild severity, autoimmune uveitis), or cerebrovascular, chronic pulmonary or cardiac disease associated with functional limitation, retinopathy, uncontrolled thyroid disease, (TSH \\>10 or \\\u003C0.4mU\u002FL) or uncontrolled seizure disorder, as determined by a study physician.\n26. Use of another investigational agent within 90 days of screening\n27. Use of any prohibited immunosuppressants (except short term use of prednisone as a steroid burst \\[\\\u003C= 1 week of use\\]) or cytotoxic medications\n28. Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study.\n29. Inability of subject to understand and the unwillingness to sign a written informed consent document",{"count":412,"type":22},50,[102],"Background:\n\nChronic hepatitis B virus (HBV) infection affects 292 million people worldwide; 887,000 die each year from cirrhosis, liver cancer, and related issues. Treatment options are limited.\n\nObjective:\n\nTo test 2 drugs (VIR-2218 and peginterferon) in people with mild or inactive HBV infection.\n\nEligibility:\n\nPeople aged 18 to 65 years with mild or inactive HBV infection.\n\nDesign:\n\nParticipants will be screened. They will have blood tests and an eye exam. They will have imaging scans of the liver to check the health of the liver.\n\nParticipants will be in the study for over 2 years.\n\nVIR-2218 is an injection given under the skin of the stomach, upper arm, or thigh. Participants will come to the clinic to receive this injection once a month for 6 months.\n\nPeginterferon is also injected under the skin. Participants will have this shot once a week for 6 months. They may either inject themselves at home or come to the clinic to get the injections.\n\nParticipants will get just the VIR-2218 for 3 months, then both shots for 3 months, then just the peginterferon for 3 months.\n\nParticipants will have two 3-day stays in the hospital. Tests will include:\n\nLiver biopsy. A sample of tissue will be taken from their liver. After the procedure, participants will lie on their right side for 2 hours and then on their back for 4 hours.\n\nFine needle aspiration. A small needle will be used to collect cells from the liver.\n\nAfter the last injection of peginterferon, follow-up visits will continue in the outpatient clinic every 4 to 12 weeks.",[416],"Chronic Hepatitis B",[416,418,419,420],"Treatment","Functional Cure","Immune Response",{"date":353,"type":35},{"date":423,"type":35},"2025-01-31",{"date":425,"type":22},"2028-08-31",{"name":41,"class":42},{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":434,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":436,"conditions":437,"keywords":438,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":43},"100515824","feasibility-of-adipose-tissue-triglyceride-tg-labelling-in-familial-partial-lipodystrophy-fpld-100515824","NCT05996536","Feasibility of Adipose Tissue Triglyceride (TG) Labelling in Familial Partial Lipodystrophy (FPLD)","A Pilot Study to Assess Feasibility of Adipose Tissue Triglyceride (TG) Labelling in Familial Partial Lipodystrophy (FPLD)","* INCLUSION CRITERIA:\n\nCommon inclusion criteria (FPLD and Controls):\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Age \\>= 18 and \\\u003C= 65 years\n3. Agreement to adhere to Lifestyle Considerations throughout study duration.\n4. Weight stability (per the subject) within approximately 3 kg in the 3 months prior to screening, with no plans to actively gain or lose weight during the study period.\n\nFPLD-specific inclusion criteria:\n\n1. Clinical diagnosis of partial lipodystrophy based on reduction in adipose tissue outside the normal range in selected adipose depots (including, at a minimum, the gluteofemoral depot) with preservation of adipose tissue in other depots.\n2. Adequate abdominal and thigh adipose tissue for feasible subcutaneous fat biopsy, as judged by the investigator.\n\nCONTROL MATCHING CRITERIA:\n\nWhen possible, control subjects will be individuals matched 1:1 with the FPLD subjects based on the following criteria (in order of priority). These criteria will be considered when assessing eligibility but are not strict inclusion criteria.\n\n1. Sex\n2. Age plus-minus 5 years\n3. Diabetic status\n4. Abdominal circumference plus-minus 10 cm\n5. Height plus-minus 5 cm\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Uncontrolled diabetes, defined as HbA1C \\>8% at screening.\n2. Use of insulin secretagogues (sulfonylureas) in week prior to Study Visit 1.\n3. Changes in insulin dose \\>30% of total daily dose in the 2 weeks prior to Study Visit 1.\n4. Use of niacin in the week prior to Study Visit 1.\n5. Use of antiplatelets that cannot be safely held for the appropriate duration prior to each biopsy visit, including Plavix (one week prior to biopsy), aspirin (one week prior to biopsy) and NSAIDS (48 hours prior to biopsy).\n6. Chronic use of anticoagulant medications that cannot be safely stopped for an appropriate duration of time prior to a biopsy procedure.\n7. Lipemia defined as non-fasting triglycerides of \\>1000 mg\u002FdL at screening.\n8. Renal dysfunction defined as GFR \\\u003C60 mL\u002Fmin\u002F1.73 m\\^2 at screening.\n9. Consuming extreme macronutrient diet (e.g., very low-carbohydrate, high fat diets such as ketogenic, paleo or Atkins diets, among others).\n10. Positive pregnancy test or breastfeeding at screening.\n11. History of HIV, hepatitis B or C infection.\n12. History of acquired lipodystrophy.\n13. Clinically significant abnormalities in thyroid function, liver function, blood counts, or blood minerals as assessed by screening labs.\n14. Inability to comply with planned study procedures.\n15. Inability of subject to understand and the willingness to sign a written informed consent document.\n16. Any condition which in the opinion of the investigator increases risk to subjects, prevents subject from complying with study procedures, prevents the subject from completing the study, or interferes with the interpretation of study results.",{"count":435,"type":22},14,"Background:\n\nPeople with familial partial lipodystrophy (FPLD) do not store fat in the body normally. This can lead to serious illnesses such as diabetes and heart disease. To learn more about FPLD, researchers want to compare the fat tissue in people with this disease to the fat tissue of healthy people.\n\nObjective:\n\nTo collect and analyze samples of fat tissue in people with and without FPLD.\n\nEligibility:\n\nPeople aged 18 to 65 years with FPLD. Healthy adults are also needed.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam. The size and shape of their body will be measured. They will have an imaging scan to measure their bones, muscle, and fat.\n\nParticipants will be given heavy water to drink at home. The water contains a tracer to help measure the fat in their blood. They will drink 1 vial 3 times a day.\n\nAfter drinking the water for 9 days, participants will come to the clinic for a 3-day stay. They will eat only foods provided by the hospital; the foods will contain tracers. A needle will be inserted into a vein in the arm; participants will receive infusions of other tracers through this needle into their blood; this needle will also be used to draw blood samples for testing.\n\nOn their third day in the clinic, participants will have biopsies: Small samples of fat will be removed from under the skin on the belly and thigh.\n\nParticipants may return for a follow-up visit 8 days after leaving the clinic. Blood draws and fat tissue biopsies will be repeated.",[106],[106,439],"Adipose Tissue",{"date":353,"type":35},{"date":442,"type":35},"2024-01-03",{"date":444,"type":22},"2027-06-01",{"name":41,"class":42},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":100,"phases":455,"briefSummary":456,"conditions":457,"keywords":460,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":43},"100475405","phase-2-study-of-growth-hormone-inhibition-using-pegvisomant-in-severe-insulin-resistance-100475405","NCT05470504","Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance","Phase II Study of Growth Hormone Inhibition Using Pegvisomant In Severe Insulin Resistance","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all the following criteria:\n\n* Either\n\n  * Known pathogenic variant in the insulin receptor gene, either dominant negative or recessive, OR\n  * Clinical diagnosis of partial lipodystrophy based on reduction in adipose tissue outside the normal range in selected adipose depots (including, at a minimum, the gluteofemoral depot) with preservation of adipose tissue in other depots.\n* Male or female, aged 18-70 years.\n* Completed linear growth and puberty.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Use of niacin or other drugs that directly affect lipolysis within 8 weeks prior to enrollment.\n* Patients taking anticoagulants (blood thinning medications).\n* Use of non-steroidal anti-inflammatory medications (e.g., aspirin, ibuprofen) 2 weeks prior to the biopsy date (in patients who choose to undergo biopsy).\n* Changes in medications for diabetes or dyslipidemia within 2 weeks prior to enrollment.\n* Pregnancy or lactation.\n* For females of reproductive potential: inability or unwillingness to use contraception during study participation and for an additional 1 month after the end of pegvisomant administration.\n* For males of reproductive potential: inability or unwillingness to use condoms or other methods to ensure effective contraception with partner during the study and for an additional 1 month after the end of pegvisomant administration.\n* Known allergic reactions pegvisomant or any of its components.\n* Clinically significant liver disease, evidenced by any of the following:\n\n  * ALT or AST \\>3 times the upper limit of normal at screening.\n  * Current known liver disease other than steatohepatitis (e.g., autoimmune or viral hepatitis).\n  * History of cirrhosis\n* Triglycerides \\>1500 mg\u002FdL (non-fasting) or \\>1000 mg\u002FdL (fasting) at screening.\n* In subjects with partial lipodystrophy only, Hemoglobin A1c \\>10% at screening.\n* Any other medical condition or medication that, in the judgement of the investigator, will increase risk to the subject or impede the measurement of study outcomes.\n* Inability of subject to understand or the unwillingness to sign a written informed consent document.","70 Years",{"count":7,"type":22},[102],"Background:\n\nLipodystrophy (LD) syndromes are a group of rare disorders that affect how a person s body can store and use fat tissue. Many people with LDs become severely insulin resistant. Some people are insulin resistant because of a variant in the insulin receptor gene. Insulin resistance causes many health problems.\n\nObjective:\n\nTo learn if blocking the effects of growth hormone in the body will help people with severe insulin resistance.\n\nEligibility:\n\nAdults aged 18 to 65 years with either a known variant in the insulin receptor gene or with a diagnosis of partial LD.\n\nDesign:\n\nParticipants will have 2 hospital stays, about 1 month apart. Each stay will be 3 or 4 nights.\n\nDuring each hospital stay, participants will have many tests. They will have a physical exam with blood tests. They will have all of their urine collected for a 24-hour period. They will have scans to measure their muscle, bone, and fat tissues. They will have tests to measure metabolism and insulin sensitivity. They may have an optional biopsy of fat tissue.\n\nDuring the first hospital visit, participants will learn how to give themselves shots of a drug (pegvisomant) that blocks growth hormone. The drug is injected under the skin. Participants will continue to give themselves these shots once a day at home.\n\nAfter the first hospital visit, participants will talk on the phone with members of the study team once each week. After 2 weeks they will have blood drawn for tests.\n\nParticipants will stop the shots after the second hospital visit.",[458,459],"Insulin Receptor Mutation","Partial Lipodystrophy",[461,462,463,464],"Pegvisomant","Severe Insulin Resistance","Growth Hormone Inhibition","LIPOLYSIS",{"date":353,"type":35},{"date":467,"type":35},"2023-01-23",{"date":469,"type":22},"2028-01-30",{"name":41,"class":42},{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":17,"minAge":298,"maxAge":299,"enrollmentInfo":477,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":479,"conditions":480,"keywords":481,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":43},"100471450","natural-history-of-pregnancy-and-pregnancy-outcomes-in-metreleptin-treated-vs-untreated-subjects-with-lipodystrophy-100471450","NCT05419037","Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Women with lipodystrophy who had pregnancies with or without use of metreleptin:\n\n  * Female, aged \\>= 18 years\n  * Clinical diagnosis of non-HIV associated generalized or partial lipodystrophy\n  * History of one or more pregnancies\n* Offspring of women with lipodystrophy who had pregnancies while taking metreleptin:\n\n  * Males or females aged \\>=1 month\n  * Mothers took metreleptin during their pregnancy\n  * Availability of a biobanked blood specimen or willingness to provide a blood specimen\n\nNote that subjects treated with metreleptin during pregnancy may participate in this study regardless of the participation of their offspring.\n\nEXCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must not meet any of the following criteria:\n\n* Inability of subject or guardian to understand or the unwillingness to sign a written informed consent document (except as noted below with \\*)\n* Pregnancy.\n\n  * Subjects who otherwise meet inclusion\u002Fexclusion criteria but who are not reachable to obtain informed consent may be included under a waiver of consent.",{"count":478,"type":22},90,"Background:\n\nLipodystrophy is a health problem in which the body does not have enough fat tissue. People with lipodystrophy may not make enough of the hormone leptin. Leptin regulates hunger. Low leptin levels trigger hunger. People with lipodystrophy can have many health problems. They may take a drug (metreleptin) that mimics leptin. Little is known about how taking metreleptin may affect a pregnancy. Metreleptin may be helpful or harmful to pregnant women. It may also affect the health of the child who is born.\n\nObjective:\n\nThis natural history study will collect data about the effects of taking metreleptin while pregnant.\n\nEligibility:\n\nWomen aged 18 years or older with lipodystrophy who have been pregnant. Women who did and who did not take metreleptin during their pregnancies are needed. Children of women with lipodystrophy who took this drug during pregnancy are also needed.\n\nDesign:\n\nParticipants will have 1 study visit. This visit may be by phone, by telehealth, or in-person.\n\nParticipants will answer questions about their pregnancies.\n\nThey will discuss any health problems they had.\n\nThey will be asked about any medicines they took before and during their pregnancies.\n\nThey will be asked about the health of their children.\n\nParticipants medical records will be reviewed.\n\nParticipants may need to provide a blood sample. They may also be asked to provide a sample of breastmilk.\n\nParticipants children may also be asked to provide a blood sample....",[106],[482,483,484,200],"Metreleptin","Pregnancy","Off-Spring",{"date":353,"type":35},{"date":487,"type":35},"2022-09-07",{"date":489,"type":22},"2029-03-01",{"name":41,"class":42},{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":213,"sex":17,"minAge":18,"maxAge":191,"enrollmentInfo":497,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":499,"conditions":500,"keywords":502,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":43},"100415097","unraveling-the-mechanisms-underlying-primary-sclerosing-cholangitis-through-a-multidisciplinary-integrative-research-approach-100415097","NCT04685200","Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach","* PSC SUBJECTS:\n\nINCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Male or nonpregnant female, greater than or equal to 18 years of age\n3. Evidence of PSC established by biochemical testing and either MRCP or ERCP. Participant must have evidence of large duct disease on imaging.\n4. Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnant or lactating women or females of child-bearing age not taking measures to prevent pregnancy during the period of study.\n2. History of clinical, serologic, or histopathologic evidence supporting etiologies of chronic liver disease other than PSC\n3. History of liver transplantation\n4. Diagnosis consistent with secondary sclerosing cholangitis (cholelithiasis, bile duct strictures secondary to ischemia, HIV cholangiopathy, etc.).\n5. Current or past clinical evidence of decompensated liver disease (e.g. ascites, bleeding esophageal varices, spontaneous bacterial peritonitis, encephalopathy, etc.).\n6. History of liver or bile duct lesions concerning for malignancy.\n7. Ca-19-9 \\>130 U\u002FmicroL\n8. Alpha-fetoprotein level greater than 200 ng\u002FmicroL.\n9. Patients with active bacterial, viral, or fungal, systemic or localized infection.\n10. Unwillingness to refrain from ingesting probiotics during study.\n11. History of systemic disease not related to PSC that is poorly controlled or associated with declining functional status. Examples include but are not limited to: poorly controlled diabetes mellitus, chronic renal failure with eGFR is \\\u003C60 microl\u002Fmin\u002F1.73m\\^2, chronic\n\n    symptomatic heart failure or severe COPD.\n12. Patients with history of any gastrointestinal malignancy in the last 3 years prior to enrollment will be excluded. Patients with history of any malignancy in the last 3 years prior to enrollment other than those individuals who had undergone curative surgical therapy and deemed as low risk for recurrence by her\u002Fhis treating physician would be excluded.\n13. History of portal vein thrombosis\n14. Patients with severe allergic reactions to iodine or other contrast, which cannot be controlled by premedication with antihistamines or steroids.\n15. History of gastric and\u002For proximal small bowel surgery including bariatric surgery such as Roux-en-Y gastric bypass\n16. Contraindication to monitored anesthesia care and\u002For medications that are commonly used for conscious sedation during GI Endoscopy\n17. Use of anti-coagulant and anti-platelet agents excluding aspirin and NSAIDs\n18. Contraindications to completing MRCP or MRI\n19. Absolute neutrophil count below 1000\u002Fmm\\^3\n20. Hemoglobin level below 10.0 g\u002Fdl\n21. Platelet count lower than 50,000\u002Fmm\\^3.\n22. INR greater than or equal to 1.5, PTT greater thna or equal to 1.3 times control and\u002For any known history of disease associated with\n\n    increased bleeding diathesis.\n23. Inability to provide informed consent\n\nCONTROLS:\n\nINCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female greater than or equal to 18 years of age\n2. Any individual who is either a parent, sibling or child of a PSC patient enrolled to the study, or an unrelated person who has been living with the patient for at least 3 consecutive months before study enrollment\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History suggestive of PSC\n2. History of chronic liver disease (except for steatosis)\n3. Patients with history of any malignancy in the 3 years prior to enrollment other than those individuals who had undergone curative surgical therapy and deemed as low risk for recurrence by her\u002Fhis treating physician would be excluded.\n4. History of Inflammatory Bowel Disease\n5. Antibiotic use within the last 6 weeks\n6. Pregnancy\n7. Inability to provide informed consent",{"count":498,"type":22},143,"Background:\n\nPrimary sclerosing cholangitis is a rare chronic liver disease. It affects the bile ducts of the\n\nliver. It can result in bile duct infections, cirrhosis, cancer, and end stage liver disease. Researchers want to learn more about this disease.\n\nObjective:\n\nTo understand the biological causes of primary sclerosing cholangitis.\n\nEligibility:\n\nAdults age 18 and older who have primary sclerosing cholangitis.\n\nDesign:\n\nParticipants will be screened with a medical history, physical exam, and blood tests.\n\nParticipants will give blood, saliva, urine, and stool samples. They will have nasal swabs. They will complete surveys.\n\nParticipants will get an intravenous (IV) catheter. A plastic tube is inserted into an arm vein.\n\nParticipants will have a colonoscopy. A tube with a video camera at the end is inserted into the rectum.\n\nParticipants will have an upper endoscopy. A scope with a light and camera at its tip is used to look inside the upper digestive tract.\n\nParticipants will have a liver biopsy, entering through the chest wall or a neck vein. Blood is drawn from a blood vessel that carries blood to the liver. A liver tissue sample is taken.\n\nParticipants will have magnetic resonance imaging or spectroscopy. They will get a contrast agent through an IV.\n\nParticipants may have an optional bone marrow aspiration. A large needle is inserted into the hip to withdraw marrow.\n\nParticipants will have a liver ultrasound.\n\nParticipants will complete a 3-day food diary. They will have a nutrition assessment.\n\nParticipants may give contact details for people who live with them, to also take part in this study.\n\nParticipation will last for 12 months.",[501],"Primary Sclerosing Cholangitis",[55,198,200],{"date":353,"type":35},{"date":505,"type":35},"2023-03-31",{"date":507,"type":22},"2026-10-31",{"name":41,"class":42},{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":191,"enrollmentInfo":515,"targetDuration":4,"studyType":100,"phases":517,"briefSummary":518,"conditions":519,"keywords":520,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":43},"100350346","phase-2-the-use-of-124-i-petct-whole-body-and-lesional-dosimetry-in-differentiated-thyroid-cancer-100350346","NCT03841617","The Use of 124-I-PET\u002FCT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer","* INCLUSION CRITERIA:\n* Patients with established thyroid cancer diagnosis based on the pathology report reviewed at the National Institutes of Health, who:\n\n  * underwent total thyroidectomy plus or minus neck lymph node dissection as clinically indicated,\n  * are presenting with known per structural imaging (US neck, CT or MRI neck\u002Fchest\u002Fabdomen\u002Fpelvis) persistent\u002Frecurrent disease either locally advanced or presenting with distant metastases; or\n  * are presenting with suspected persistent\u002Frecurrent locoregional or distant metastases based on the high risk features such as advanced tumor per pathology report (tumor size \\>4 cm, exrathyroidal extension, higher risk pathology such as tall cell, columnar cell, poorly differentiated variant, follicular thyroid cancer with gross vascular invasion, positive margins after the surgery, bulky lymphadenopathy in the central and\u002For lateral neck), detectable\u002Fincreasing baseline\u002Fsuppressed thyroglobulin (Tg) level or detectable\u002Fincreasing anti-Tg antibody titers if anti-Tg antibodies are present.\n  * are either RAI -naive or requiring repeated RAI therapy for locally advanced disease or distant metastases or underwent therapy with BRAF inhibitor (dabrafenib or vemurafenib\\*) or selumetinib\\*\\* for at least 4 weeks that may re-induce RAI uptake.\n  * Underwent imaging with either a CT or MRI of the brain and spine with gadolinium contrast to screen for the brain\u002Fspine metastases.\n\n    * Age greater than or equal to 18 years of age.\n    * 24 hour urine iodine excretion of less than or equal to 150 micro grams\u002F24 hour.\n\n      * BRAF inhibitors are recommended by 2021 NCCN guidelines as one of the management options for BRAF mutant tumors(13,14)\n\n        * Selumetinib has an FDA orphan drug designation for adjuvant treatment of metastatic thyroid cancer to re-induce RAI uptake\n\nEXCLUSION CRITERIA:\n\n-Patients with RAI-non avid disease documented by negative post-therapy whole body scans performed after previous RAI treatments and not subjected to re-differentiation therapy.\n\n* Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma, severe depression which might be exacerbated by thyroid hormone withdrawal.\n* Patients with spinal or brain metastases as they are at risk of TSH-stimulation induced swelling of metastatic lesions leading to potentially detrimental side effects. These patients will be evaluated per the standard of care protocol 77-DK-0096.\n\n  * Pregnant or lactating women per self report.\n  * Adults who are incapable of providing informed consent.",{"count":516,"type":22},30,[102],"Study rationale\n\nHigh risk patients with differentiated thyroid cancer (DTC) require therapy with 131 I under thyroid stimulating hormone (TSH) stimulation. There are two methods of TSH stimulation endogenous by thyroid hormone withdrawal (THW) leading to hypothyroidism and exogenous by injection of human recombinant TSH (rhTSH Thyrogen). The appropriate 131-I activity utilized for treatment is either based on empiric fixed dosage choice or individually determined activity based on 131 I dosimetric calculations. Although dosimetry utilizing radioactive iodine isotope 131 I enables calculation of maximum safe dose, it does not estimate the tumoricidal activity necessary to destroy the metastatic lesions. The alternative radioactive isotope of iodine -124 I, used for positron emission tomography (PET) imaging, might be used for calculation not only the maximum safe131 I dose, but also to predict the absorbed dose in the metastatic lesions.\n\nStudy objectives\n\nThe primary objective of this study is to compare the 124 I -PET\u002FCT lesional and whole body dosimetry in each individual patient with metastatic radioiodine (RAI)-avid thyroid cancer under preparation with rhTSH and THW. The secondary objective is to evaluate the predicted by PET\u002FCT lesional uptake with the early response to therapy.\n\nStudy design\n\nThis is a phase 2 pilot prospective cohort study comparing the lesional and whole body dosimetry within each patient undergoing exogenous (rhTSH) and endogenous (THW) TSH stimulation and followed for 5 years.\n\nInterventions\n\nEach study participant will undergo rhTSH and THW-aided 124 I-PET\u002FCT dosimetric evaluations and will be subsequently treated with THW-aided RAI activity based on dosimetric calculations enabling maximum safe dosage. The patients will be followed in 12+\u002F-3 months intervals for 5 years.\n\nSample size and population\n\nThis pilot study will include 30 patients with high risk differentiated thyroid cancer presenting with distant and\u002For loco-regional metastases.\n\n...",[155],[155,521,522,310,523],"PET\u002FCT","124-I","Metastases",{"date":353,"type":35},{"date":526,"type":35},"2019-07-29",{"date":528,"type":22},"2035-11-01",{"name":41,"class":42},{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":536,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":538,"conditions":539,"keywords":541,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":4,"leadSponsor":552,"locationsCount":43},"100106168","natural-history-of-familial-carcinoid-tumor-100106168","NCT00646022","Natural History of Familial Carcinoid Tumor","* INCLUSION CRITERIA:\n\nThere are four types of participants who will be included in this protocol as outlined below.\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria for their group:\n\nGroup 1 (Arm 1 or Arm 2)\n\n* Male and female subjects \\>= 18 years of age\n* Have a diagnosis of small intestinal carcinoid tumor\n* Have at least one blood relation with a diagnosis of either small intestinal, pulmonary, kidney or gastropancreatic neuroendocrine tumor or metastatic neuroendocrine tumor of unknown primary\n\nGroup 2 (Arm 1 or Arm 2)\n\n* Male and female subjects \\>= 18 years of age\n* Has multiple synchronous primary small intestinal tumors\n\nGroup 3 (Arm 1 or Arm 2)\n\n* Male and female subjects \\>=18 years of age\n* Does not have a diagnosis of carcinoid tumor\n* Has one of the following:\n\n  * at least two blood relatives with any combination of diagnoses of small intestinal carcinoid tumor, a pulmonary, kidney, gastropancreatic neuroendocrine tumor or metastatic neuroendocrine tumor of unknown primary OR\n  * has at least one blood relative with multiple, synchronous primary small bowel tumors\n\nGroup 4 (Arm 2 only)\n\n* Male and female subjects \\>= 18 years of age\n* Not biologically related to the participating family but has offspring who is\u002Fare blood relative(s) of a participating subject.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this\n\nstudy:\n\n1. Members of families with multiple endocrine neoplasia (MEN) I, MEN II or other familial tumor syndromes such as Von Hippel Lindau Syndrome and Neurofibromatosis type I and type II for which there is a known genetic predisposition to non-carcinoid tumors as well as\n\n   carcinoid tumors will be excluded from the study.\n2. Any condition which, in the opinion of the investigator, would make it unsafe to participate or would prohibit completion of the protocol.\n3. Inability to provide informed consent (Arm 1 only)\n4. Pregnant or breastfeeding (Arm 1 only)",{"count":537,"type":22},1600,"This study will evaluate members in families with a history of small bowel carcinoid cancer to study the natural history of those family members that have the disease, determine ways to improve early detection by performing surveillance on those at risk but without disease and to identify the gene(s) that may cause the tumors. Familial carcinoid tumors usually originate in hormone-producing cells that line the small intestine or other cells of the digestive tract. The tumors are slow-growing and usually take many years before they cause symptoms. It is known that these tumors occur more often in some families and are then passed from one generation to the next by inherited genes.\n\nMembers of families, including all siblings and offspring in which two or more immediate blood relatives have had small bowel carcinoid tumors are eligible for this study. In some cases unaffected spouses of family members diagnosed with carcinoid cancer are also requested to participate by donating a sample of blood only.\n\nParticipants undergo a medical evaluation every 3 years during a 3- to 5-day hospital stay at the NIH Clinical Center. All participants have a personal and family medical history obtained and undergo a physical examination, blood and urine tests.\n\nPeople who already have a small bowel carcinoid tumor or are at risk of developing a carcinoid tumor have some or all of the following procedures to determine the presence of carcinoid tumor and its (omit next two words- location or) spread to other areas of the body:\n\n* Video Capsule Endoscopy: Visualization of the gastrointestinal tract by ingesting a disposable, \"vitamin-pill sized\" video capsule that has its own camera and light source.\n* CT of the chest abdomen and pelvis with oral and IV contrast : X-ray examination of the chest, abdominal and pelvis organs.\n* 18 FDOPA Positron emission tomography (PET) with CT for localization: Nuclear imaging scan to look at tumor activity.\n* MRI Liver with contrast - to determine if disease has spread to liver\n* Gallium 68 PET\u002FCT-limited to individuals that have residual tumor.\n* Clinical and research blood work\n\nShould mid gut carcinoid tumors be found every participant will be assisted in determine what the best course of treatment will be for them.\n\n...",[540],"Carcinoid",[542,543,544,545,200,546,547,548],"Neuroendocrine","PET","Gastrointestinal","Serotonin","Carcinoid Tumor","Gastrointestinal Carcinoid Tumor","Familial Cancer Tumor",{"date":353,"type":35},{"date":551,"type":35},"2008-08-25",{"name":41,"class":42},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":213,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":560,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":562,"conditions":563,"keywords":567,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":4,"leadSponsor":574,"locationsCount":43},"100098389","blood-sampling-for-research-related-to-sickle-cell-disease-100098389","NCT00542230","Blood Sampling for Research Related to Sickle Cell Disease","High Sensitivity Screening of Compound Libraries to Discover a Drug for the Treatment of Sickle Cell Disease","* INCLUSION CRITERIA:\n* Patients with sickle cell trait\n* Patients with known hemoglobinopathies involving one or two genes for sickle hemoglobin\n* Healthy volunteers for control experiments\n* Age range: adults greater than or equal to 18 years of age\n\nEXCLUSION CRITERIA:\n\n* Subjects who are unable to comprehend the investigational nature of the laboratory research are ineligible to enroll in this protocol.\n* As a safety precaution in handling the blood samples, patients with HIV, Hepatitis B or Hepatitis C will be excluded from the study. HIV, Hepatitis B or Hepatitits C testing will not be done under this study. Participants must be co-enrolled under another NIH protocol where the screening evaluation has been performed.",{"count":561,"type":22},250,"This study will collect representative blood samples from healthy children and adults and from children and adults who have unique red blood cell features that are related to sickle cell disease. Sickle cell disease is a blood disease that limits the ability of red blood cells to carry oxygen throughout the body. The purpose of the study is to collect a variety of blood samples that may then be used to investigate advances and potential new drug treatments for sickle cell disease.\n\nVolunteers must be at least 18 years of old. Samples will be taken both from healthy volunteers and from volunteers who have unique red blood cell features that are related to sickle cell disease. Candidates will be screened with a medical history.\n\nDuring the study, participants will undergo a one- to two-hour outpatient procedure at the National Institutes of Health Clinical Center. Once researchers have explained the study and obtained the participant s consent, participants will donate 8 cc (approximately 2 teaspoons) of blood.\n\nBecause repeat testing helps researchers validate study findings, participants who have the unique red blood cell features mentioned above may also be asked if they are willing to return and donate another 2 cc to 8 cc of blood for additional studies. The amount of blood drawn will not exceed 50 ml with any eight-week period for adults or 7 cc within any six-week period for children....",[564,565,566],"Sickle Cell Trait","Sickle Cell Disease","Sickle Cell Anemia",[568,569,564,570,565,200],"Erythrocytes","Drug Screen","Sickle Hemoglobin",{"date":353,"type":35},{"date":573,"type":35},"2007-11-07",{"name":41,"class":42},""]