[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-disease":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,65,0,25,[9,46,94,144,176,204,230,262,291,325,349,369,393,424,445,466,511,541,561,585,606,630,652,682,702],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100430733","natural-history-of-the-human-biological-response-to-environmental-exposure-and-injury-100430733",false,"NCT04888923","Natural History of the Human Biological Response to Environmental Exposure and Injury","Natural History of The Human Biological Response to Environmental Exposure and Injury","* INCLUSION 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. Ability to provide informed consent.\n3. Able to read and speak English\n4. Male or female, aged \\>=18\n5. Able to travel to the NIEHS CRU for study visits or travel to an offsite event or conference.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Not willing to have samples stored for future use.\n2. Current pregnancy or lactation, by participant verbal confirmation.\n3. Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures.\n\nParticipants will be enrolled according to pre-defined host (e.g. disease, genetic, or demographic) or environmental (exposure) characteristics.",true,"ALL","18 Years","90 Years",{"count":22,"type":23},2000,"ESTIMATED","OBSERVATIONAL","Background:\n\nEnvironmental exposures like pollution, diet, and stress can help cause human diseases, or make them worse. Researchers want to better understand how injury and inflammation are caused by these exposures. They want to collect biological and environmental samples and other data. They may use the samples to measure a range of factors, like hormones, toxins, and chemicals. This will help them improve their studies.\n\nObjective:\n\nTo identify and understand how environmental exposures contribute to human disease.\n\nEligibility:\n\nHealthy adults ages 18 and older\n\nDesign:\n\nParticipants will be screened with questions about their health history, demographics, and medicines they take.\n\nParticipants may give blood, hair, stool, saliva, and\u002For urine samples. They may have a skin punch biopsy to collect skin cells. They may give fingernail or toenail clippings. They may give a sample of exhaled breath.\n\nParticipants may give a sputum sample. They will inhale a saline mist and cough mucus into a cup.\n\nParticipants may have their nasal passages brushed, scraped, or washed.\n\nParticipants may give cheek cell samples. They will swish mouthwash and spit it into a cup.\n\nParticipants who produce sperm may give samples.\n\nParticipants may have bronchoscopy to collect fluid. A saline solution will be put into their lung and then suctioned out, washing areas of the lung.\n\nParticipants may have a pelvic or transvaginal ultrasound. They may have lung function tests.\n\nParticipants may collect household dust, urine, or stool at home.\n\nParticipants will complete surveys about their health, diet, and exposures.\n\nParticipation will last for one or more study visits.\n\nParticipants may be contacted in the future to take part in other studies.",[27,28,29],"Inflammation","Normal Controls","Metabolic Disease",[31,29,27,32],"Blood Collection","Natural History","RECRUITING","2026-08-20",{"date":36,"type":37},"2026-08-21","ACTUAL",{"date":39,"type":37},"2021-11-16",{"date":41,"type":23},"2031-12-31",{"name":43,"class":44},"National Institute of Environmental Health Sciences (NIEHS)","NIH",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":61,"conditions":62,"keywords":79,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":45},"100560306","phase-1-a-study-to-investigate-safety-and-effectiveness-of-porcine-pancreatic-cells-opf-310-in-patients-with-type-1-diabetes-mellitus-100560306","NCT06575426","A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus","A Phase I\u002FIIa, Single Site, Open-Label, Ascending Dose Study to Evaluate the Safety and Efficacy of OPF-310 [Encapsulated Porcine Islet Cells for Xenotransplantation] in Subjects With Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n1. Subject must be aged 35 to 70 years of age inclusive, at the time of signing the informed consent.\n2. Subject has an established diagnosis of type 1 diabetes mellitus (T1DM) (in accordance with the American Diabetes Association's criteria), with a minimum duration since diagnosis of 5 years.\n3. If one of the following criteria (either a or b) applies:\n\n   1. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G6, insulin pump: Omnipod® 5 or t:slim X2) under care of a qualified diabetes team for at least 6 months prior to enrollment.\n   2. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G7, insulin pump: Omnipod® 5, t:slim X2, iLet Bionic Pancreas or The Tandem Mobi System) under care of a qualified diabetes team for at least 6 months prior to enrollment.\n4. If one of the following criteria (either a, b or c) applies:\n\n   1. Subject has had a Level 3 (severe) hypoglycemic episode (defined as having cognitive impairment requiring external assistance for recovery) at least three times within the 1 year prior to enrollment recorded in the medical record or patient log.\n   2. Subject has had a Level 3 (severe) hypoglycemic episode at least once within the 1 year prior to enrollment and demonstrates a Clarke Score ≥4, assessed by trained study personnel. The SHE(s) and Clarke Score must be recorded in the medical record or patient log.\n   3. Subject has had TBR \\>1% at glucose levels below 70mg\u002FdL and demonstrates a Clarke Score≥4, assessed by trained study personnel. TBR data used for screening and Clarke score must be recorded in the medical record or patient log.\n5. Subject has C-peptide \\\u003C0.3 ng\u002FmL following a mixed meal tolerance test or undetectable fasting C-peptide.\n6. Hemoglobin A1C (HbA1c) ≤ 9.0\n7. Contraceptive use must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n8. Subject who can agree to cooperate with lifetime follow-up after transplantation.\n9. Subject is capable of providing signed informed consent\n\nExclusion Criteria:\n\n1. Previous history of insulin resistance (defined as an average insulin dose requirement ≥ 0.8 unit\u002Fkg\u002Fday for 1 week prior to enrollment).\n2. Subject has latent autoimmune diabetes in adults (LADA), ketosis-prone (Flatbush) diabetes, or maturity onset diabetes of the young (MODY).\n3. CRP ≥ 10 mg\u002FL.\n4. Clinically unstable thyroid disease (thyroid stimulating hormone (TSH)\\\u003C the lower limit of the normal range of TSH at the site.) Patients with subclinical hyperthyroidism can be rescreened once TSH levels normalize due to treatment or other factors.\n5. History of malignancies within the past 5 years, excluding basal and squamous cell carcinoma\n6. Positive serologies or nucleic acid testing for human immunodeficiency virus (HIV), hepatitis C, and hepatitis B.\n7. Active or untreated proliferative diabetic retinopathy. Subjects may be rescreened once they are successfully treated.\n8. Serious comorbid conditions that are likely to affect participation in the study, including:\n\n   1. Within the last 12 months, peripheral vascular disease with previous amputation.\n   2. History of New York Heart Association (NYHA) class II, III or IV congestive heart failure (CHF) and\u002For chronic atrial fibrillation.\n   3. Chronic obstructive pulmonary disease (COPD) or asthma with previous hospitalization for decompensation; a requirement for mechanical ventilation at any stage; or long- term treatment with oral corticosteroids.\n   4. Macroalbuminuria (\\> 300 mg albumin\u002Fgm creatinine).\n   5. Estimated glomerular filtration rate (eGFR) cut-off of \\\u003C 30 ml\u002Fmin for all per Kidney Disease Improving Global Outcomes (KDOQI) and Kidney Disease Outcomes Quality Initiative (KDIGO) consensus.\n9. Use of warfarin or other anticoagulant therapy (except aspirin), or prothrombin time and international normalized ratio (PT-INR) \\> 1.5\n10. Adrenal insufficiency being treated with corticosteroids\n11. Previous pan-peritonitis\n12. Previous cardiovascular or cerebrovascular disease. NOTE: For the purposes of this exclusion criterion, \"previous cardiovascular disease\" is defined as the presence of co-existing cardiac disease, characterized by any of the following conditions:\n\n    1. Recent myocardial infarction (within past one year), or\n    2. Angiographic evidence of non-correctable coronary artery disease, or\n    3. Evidence of ischemia on functional cardiac exam (with a stress echo test recommended for subjects with a history of ischemic disease), or\n    4. Heart failure \\> NYHAII For subjects aged 65 to \\\u003C70 years who do not meet Exclusion Criterion 12 but have a history of cardiovascular or cerebrovascular disease related to the conditions above, a cardiology consultation (and consultation with other relevant specialists, as appropriate) will be required during the screening period to confirm suitability for general anesthesia and laparoscopic surgery.\n13. Patients with hematopoietic stem cell abnormalities (e.g., aplastic anemia, myelodysplastic syndrome)\n14. Patients who received a blood transfusion in the previous 90 days, are anticipated to undergo surgery during the 1-year study period that may require transfusion, or have donated blood within the previous 90 days.\n15. Previous receipt of an organ, skin allograft, or other tissue transplant from an allogeneic human or animal donor.\n16. Treatment with immunosuppressive medication.\n17. Previous abdominal surgery, excluding uncomplicated appendectomy, cholecystectomy, exploratory laparoscopy and hernia repair performed prior to 12 weeks prior to enrollment.\n18. Treatment with any hypoglycemic medication prescribed for glycemic control, other than insulin therapy.\n19. Treatment with acetaminophen or hydroxycarbamide.\n20. Use of any investigational products within 12 weeks of enrollment (before entering run-in) or 5 half-lives of the investigational product, whichever is greater.\n21. Subject has history of allergy to antibiotics (Amphotericin B, Cefazolin, Ciprofloxacin, Gentamicin), which are used during manufacture of OPF-310.\n22. Previous history of insulin allergy (including porcine insulin), pork product allergy or alginate\u002Fseaweed allergy.\n23. Panel reactive antibodies (PRA) \\> 80 %.\n24. Active drug, substance or alcohol addiction.\n25. Body mass index (BMI) \\>27 kg\u002Fm2.\n26. Any other condition that, in the opinion of the Investigator, may interfere with adherence to the study protocol, including dementia, psychiatric disorder, medical condition, or a history of non-adherence to appointments or treatments","35 Years","70 Years",{"count":56,"type":23},13,"INTERVENTIONAL",[59,60],"PHASE1","PHASE2","This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the recommended Phase 2 dose (RP2D) in adult subjects with unstable Type 1 Diabetes Mellitus (T1DM) and a level 3 (severe) hypoglycemic episode at least three times within the 1 year prior to enrollment despite treatment with a closed loop system (CLS) for at least 6 months.",[63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,29],"Diabetes Mellitus, Type 1","Hypoglycemia","Islet Cell Transplantation","Type 1 Diabetes","Type 1 Diabetes Mellitus","T1D","T1DM","T1DM - Type 1 Diabetes Mellitus","Type 1 Diabetes (T1D)","Severe Hypoglycemia","Xenotransplantation","Hypoglycemic Episode","Islet Transplantation in Diabetes Mellitus Type 1","Glucose Metabolism Disorders (Including Diabetes Mellitus)","Immune System Diseases","Autoimmune Diseases",[80,81,69,64,82,83,73,84,67,66],"Diabetes Mellitus","Diabetes Mellitus, Type1","islet cell transplantation","pig islet cell transplantation","Porcine islet cell transplantation","2026-08-19",{"date":36,"type":37},{"date":88,"type":37},"2025-06-10",{"date":90,"type":23},"2027-06-30",{"name":92,"class":93},"Otsuka Pharmaceutical Factory, Inc.","INDUSTRY",{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":18,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":105,"conditions":106,"keywords":134,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":45},"100523186","a-natural-history-study-seeks-to-understand-the-clinical-genomic-pharmacological-laboratory-and-dietary-determinates-of-pyrimidine-and-purine-metabolism-disorders-100523186","NCT06092346","A Natural History Study Seeks to Understand the Clinical, Genomic, Pharmacological, Laboratory, and Dietary Determinates of Pyrimidine and Purine Metabolism Disorders","Prospective Study of the Clinical, Genomic, Pharmacological, Laboratory, and Dietary Determinates of Pyrimidine and Purine Metabolism Disorders","* INCLUSION CRITERIA:\n\nThere are three populations that will be included in this study: subjects with known DPPM, family members of study subjects, and healthy controls.\n\nIn order to be eligible to participate in this study as a subject with a known DPPM an individual must meet all following criteria:\n\n* At least one month of age;\n\n  * A medical history that, based on the preponderance of clinical, laboratory, biochemical, and\u002For genomic evidence is consistent with DPPMs;\n  * Clinical findings that can be used to suspect disorders of purine and pyrimidine metabolism will include, but not be limited to the presence of congenital malformations, neurological, behavioral, immunological, rheumatological, hematological, renal involvement; gout; and recurrent rhabdomyolysis in one or more family members.\n  * Laboratory findings may include but not limited to elevated CPK (recurrent rhabdomyolysis); neutropenia, lymphopenia, anemia, thrombocytopenia; and immunodeficiency.\n  * Biochemical evidence may encompass but not limited to persistent laboratory abnormalities in blood and urinary urate (a terminal product of purine degradation); blood and urinary beta-alanine (a terminal product of pyrimidine degradation); characteristic findings on plasma amino acid profiles (elevated plasma aspartate and glycine); elevated orotic acid on the urine organic acid assay; presence of urate crystals in urine; abnormal findings on the purine and pyrimidine panels (e.g. plasma and urine purines \\& pyrimidines biochemical panels at Mayo, PUPYP and PUPYU).\n  * Genomic evidence may include the presence of pathogenic and likely pathogenic variants in genes known or plausibly linked to the pathways of the de novo synthesis, degradation, and salvage of purines \\& pyrimidines. Participants with variants of unknown significance in the said genes may be invited to participate in the protocol, if they have clinical, laboratory and biochemical evidence consistent with DPPMs.\n* Have a primary metabolic or genetic physician, or primary care provider; and\n* Ability of the subject, parent\u002Fs (in the case of children), or a Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nIn order to be eligible to participate in this study as an unaffected family member of a subject with known DPPM, an individual must meet all the following criteria:\n\n* At least one month of age;\n* Relationship either by blood or marriage, to an individual enrolled or about to be enrolled in the study with known DPPM;\n* Likelihood, in the expert opinion of the study team, that analysis of a sample from the individual would advance genetic or functional analysis of the affected relative s possible condition; and\n* Ability of the subject, parent\u002Fs (in the case of children), or an LAR to understand and the willingness to sign a written informed consent document.\n* If during the consenting\u002Fassenting procedure, review of medical and family history and physical exam, clinical suspicion arises that a family member has symptoms of DPPMs, additional review and\u002For studies may be recommended to clarify the clinical status.\n* Participants must have a routine clinical care team outside of NIH to enroll in this study.\n\nIn order to be eligible to participate in this study as an unrelated healthy volunteer, an individual must meet all the following criteria:\n\n* No personal or family history of DPPMs;\n* At least one month old;\n* No symptoms of DPPMs;\n* Likelihood, in the expert opinion of the study team, that a sample from the individual would advance the functional analysis of the DPPM under study;\n* And ability of the subject, parent\u002Fs (in the case of children), or an LAR to understand and the willingness to sign a written informed consent document.\n* Participants must have a routine clinical care team outside of NIH to enroll in this study.\n\nEXCLUSION CRITERIA:\n\nIndividuals meeting the following exclusion criteria are not eligible for the study:\n\n* Unrelated volunteers who are unaffected with DPPM but have intellectual disability due to other causes, such that they cannot provide informed consent without a guardian\u002FLAR, will not be enrolled in this study. Affected individuals and family member(s) of individuals with DPPM can participate in the study when appropriate informed consent is obtained (with aide of parents\u002Fguardian\u002FLAR\u002Fbioethics review when necessary).\n* Intercurrent or chronic conditions which in the opinion of the investigators, can then interfere with the interpretation of research studies (e.g. ongoing cancer treatment resulting in bone marrow suppression in a patient with DPPM also presenting with bone marrow suppression).\n* Pregnant participants as unaffected family members or as unrelated healthy volunteers are not able to join the protocol during the pregnancy.\n* Individuals without a routine clinical care team outside of the NIH cannot enroll in this study. We will ask the participants for the name of clinical care team prior to enrollment.","1 Month","100 Years",{"count":104,"type":23},999,"Background:\n\nPyrimidine and purine metabolism disorders (DPPMs) affect how the body metabolizes chemicals called pyrimidines and purines. DPPMs can cause dysfunctions throughout the body, especially in the brain, blood, kidneys, and immune system. People with DPPMs might have no symptoms, mild symptoms, or they may have severe, chronic symptoms, that can be fatal. DPPMs are not well understood, and researchers want to learn more about what causes them and how to treat them.\n\nObjective:\n\nTo learn more about factors that affect DPPMs by comparing test results from affected, uaffected family members, and healthy people.\n\nEligibility:\n\nThree types of participants are needed: people aged 1 month and older with DPPMs; their family members who do not have DPPMs; and healthy volunteers.\n\nDesign:\n\nParticipants with DPPMs will come to the clinic once a year; some may be asked to come more often. At each visit, all affected participants will have a physical exam and give samples of blood, urine, saliva, and stool. Depending on their symptoms, they may also have other procedures, such as:\n\nSwabs of their skin and inside the mouth.\n\nTests of their heart, kidney, brain, and nerve function.\n\nQuestionnaires about what they eat.\n\nDental exams, and exams of their hearing and vision.\n\nTests of their learning ability.\n\nMonitoring of their physical activity.\n\nImaging scans.\n\nPhotographs of their face and body.\n\nThese tests may be spread over up to 7 days. Affected participants may remain in the study indefinitely if they wish to.\n\nHealthy volunteers and family members will have 1 study visit. They will have a physical exam and may be asked to give blood, urine, saliva, and stool samples.",[107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,29],"AMPD3, OMIM*102772, AMP Deaminase Deficiency","AK1, OMIM *103000, Adenylate Kinase Deficiency","AMPD1, OMIM *102770, Myopathy Due to Myoadenylate Deaminase Deficiency","TPMT, OMIM *187680, Thoipurines, Poor Metabolism of","IMPDH1, OMIM *146690, Retinitis Pigmentosa Type 10, Leber Congenital Amauriosis Type 11","APRT, OMIM *102600, Adenine Phosphoribosyltransferase Deficiency","HPRT1, OMIM *308000 Lesch-Nyhan Disease","XDH, OMIM *607633, Xanthinuria Type 1","SLC2A9, OMIM *606142 Hypouricemia","SLC22A12, OMIM *607096 Hypouricemia","PRPS1 Def, OMIM *311850, Arts Syndrome; Charcot-Marie-Tooth Disease","PRPS1 SA, OMIM *311850 Gout, PRPS-related Phosphoribosylpyrophosphate Synthetase Superactivity","AMPD2, OMIM *102771, Spastic Paraplegia 63; Pontocerebellar Hypoplasia","ITPA, OMIM *147520, Inosine Triphosphatase Deficiency; Developmental and Epileptic Encephalopathy 35","ADSL, OMIM *608222, Adenylosuccinate Lyase Deficiency","PNP, OMIM *164050, Nucleoside Phosphorylase Deficiency","ADA2, OMIM *607575,Sneddon Syndrome; VAIHS","CAD, *1140120, Developmental and Epileptic Encephalopathy","UPB1, OMIM *606673, Beta-ureidopropionase Deficiency","DPYS, OMIM *613326, Dihydropyrimidinase Deficiency","DPYD, OMIM *274270, Dihydropyrimidine Dehydrogenase Deficiency","DHODH, OMIM *126064, Miller Syndrome (Postaxial Acrofacial Dysostosis)","UMPS, OMIM *613891, Orotic Aciduria","NT5C3A\u003CTAB>, OMIM *606224, Anemia, Hemolytic, Due to UMPH1 Deficiency","UNG, OMIM *191525, Hyper-IgM Syndrome 5","AICDA, OMIM *605257, Immunodeficiency With Hyper-IgM, Type 2; HIGM2","Purine-Pyrimidine Metabolism",[135],"Pyrimidine and Purine Metabolism Disorders","2026-08-18",{"date":85,"type":37},{"date":139,"type":37},"2023-12-19",{"date":141,"type":23},"2099-01-01",{"name":143,"class":44},"National Human Genome Research Institute (NHGRI)",{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":17,"sex":18,"minAge":151,"maxAge":102,"enrollmentInfo":152,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":154,"conditions":155,"keywords":161,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":4,"leadSponsor":173,"locationsCount":175},"100143838","characterization-of-patients-with-uncommon-presentations-andor-uncommon-diseases-associated-with-the-cardiovascular-system-100143838","NCT01143454","Characterization of Patients With Uncommon Presentations and\u002For Uncommon Diseases Associated With the Cardiovascular System","Cardiovascular Disease Discovery Protocol","* INCLUSION CRITERIA:\n\nEligible subjects may include anyone over 1 year of age who is affected with diseases\u002Fdisorders (index cases), or who is a relative of a person who is affected with diseases\u002Fdisorders. Relatives may include genetic carriers and non-carriers.\n\n* Healthy adult volunteers must be 18 years of age or older, and must agree to have blood or tissue samples studied, and potentially stored for future research.\n* Index cases enrolled in this protocol will have been referred with a known or suspected pathology that may be associated with cardiovascular dysfunction or risk with a suspected atypical presentation, heritable disorder, or genetic predisposition. The investigator with expertise in the presentation of the subject, along with consulting specialists, will review the medical history and may review any medical records that are available of prospective subjects and offer admission based upon the potential to help the individual, to learn from the subject, or to initiate clinical or basic research suggested by the subject s workup.\n\nEXCLUSION CRITERIA:\n\n* Persons of less than 1 year of age or greater than 100 years of age\n* Healthy volunteers unable to give informed consent or who decline to have blood and\u002For tissue studies, or who do not consent to have samples stored for future research may be excluded from this study.\n* Pregnant women\n* Persons who are not fluent in the English language will be excluded from Patient Reported Outcome Questionnaires. Such persons would be unable to properly complete questionnaires that are only valid in the English language.","1 Year",{"count":153,"type":23},5000,"Background:\n\n\\- Researchers are interested in studying individuals who have known or suspected metabolic, inflammatory or genetic diseases that may put them at a high risk for heart diseases or diseases of their blood vessels. Depending on the condition being studied, both affected and nonaffected individuals may be asked to provide blood and other samples and may undergo tests to evaluate the heart, blood vessels and lung function. The testing is tailored to the individual and\u002For condition being studied. Nonaffected individuals may include relatives of affected individuals and healthy nonrelated volunteers.\n\nObjectives:\n\n\\- To study individuals who have or are at risk for cardiovascular diseases, and in some cases their unaffected relatives and healthy volunteers.\n\nEligibility:\n\n\\- Individuals between 1 and 100 years of age. Participants may be healthy volunteers, individuals with cardiovascular diseases, or unaffected relatives of individuals with cardiovascular diseases.\n\nDesign:\n\n* Participants will have some or all of the following tests, as directed by the study researchers:\n* Photography of the face and full body\n* Body measurements\n* Radiography, including chest or limb x-rays\n* Metabolic stress testing to study heart and muscle function\n* Echocardiography to study heart function\n* Magnetic resonance imaging (MRI) studies, including cardiovascular MRI, angiography, and contrast MRI, to study heart function and performance\n* Computed tomography (CT) angiogram to obtain images of the heart and lungs\n* Positron emission tomography (PET) imaging to study possible fat infiltration of the heart\n* Six-minute walk test to study heart, lung, and muscle function and performance\n* Vascular ultrasound to study blood vessel walls\n* Blood, tissue, and other specimens will be collected for research and testing, and will be taken either as part of the clinical study or during surgical procedures.\n* Follow-up studies may be performed under separate research protocols.",[29,156,157,158,159,160],"Obesity","Li-Fraumeni Syndrome","Cardiomyopathy","Atherosclerosis","Inflammatory Disease",[162,163,164,165,32,166,167],"Cardiac Disease","iPS Cells","Cardiac Risk Factors","Cardiac Disease Discovery","Heart Disease","Heart Disease Risk","2026-08-14",{"date":170,"type":37},"2026-08-17",{"date":172,"type":37},"2010-07-21",{"name":174,"class":44},"National Heart, Lung, and Blood Institute (NHLBI)",3,{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":182,"maxAge":102,"enrollmentInfo":183,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":185,"conditions":186,"keywords":191,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":45},"100268136","evaluation-of-children-with-endocrine-and-metabolic-related-conditions-100268136","NCT02769975","Evaluation of Children With Endocrine and Metabolic-Related Conditions","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Participants with known or suspected endocrine disorder age 3 months-18 years are eligible for this protocol.\n* Relatives ages 3 months-100 years may be enrolled if clinically indicated for the diagnosis of a proband.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Lack of suspected endocrine disorders.\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 patient, will exclude participation. Patients 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 NICHD resources will be excluded.","3 Months",{"count":184,"type":23},15000,"Background:\n\nEndocrine glands give off hormones. Researchers want to learn more about the disorders that affect these glands in children. These disorders might be caused by changes in genes. Genes contain DNA, which is the blueprint of how a cell works. Researchers want to identify the genes involved in endocrine and metabolic disorders. This might help develop new ways to diagnose and treat the disorders.\n\nObjective:\n\nTo study the inheritance of endocrine or metabolism disorders.\n\nEligibility:\n\nChildren ages 3month-18 with known or suspected endocrine or metabolism disorders.\n\nFamily members ages 3months-100. They may participate in the DNA part of the study.\n\nDesign:\n\nParticipants will be screened with a review of their medical records. Their parents or guardians will allow the records to be released.\n\nParticipants will have a clinic visit. This may include a physical exam and medical history.\n\nParents or guardians will give their consent for the study. Participants may have tests, surgery, or other procedures to help diagnose or treat their condition. These could include:\n\nBlood, urine, and saliva tests\n\nGrowth hormone test\n\nPituitary and adrenal function tests\n\nPicture of chromosomes\n\nImaging tests. These may include X-ray, ultrasound, scans, or a skeletal survey.\n\nGenetic tests\n\nSleep study\n\nMedical photographs\n\nIf surgery is done, a tissue sample will be taken.\n\nParticipants may have follow-up visits for diagnosis and treatment.\n\nParticipating relatives will have one visit. This will include medical history and blood and saliva tests. The blood and saliva will be used for DNA testing.",[187,188,189,29,190],"Adrenal Insufficiency","Growth Disorder","Endocrine Diseases","Bone Diseases, Metabolic",[192,156,193,188,194],"Endocrinology","Pediatric","Pubertal Development","2026-08-12",{"date":197,"type":37},"2026-08-13",{"date":199,"type":37},"2016-07-12",{"date":201,"type":23},"2030-12-31",{"name":203,"class":44},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)",{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":212,"minAge":19,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":57,"phases":215,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":45},"100521693","continence-sexual-function-fitness-and-the-health-of-men-after-surgery-for-prostate-cancer-100521693","NCT06072911","Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer","Continence, Sexual and Metabolic Health Programming to Promote Prostate Cancer Wellness for Life (CONTROL4LIFE)","CONTROL4LIFE","Inclusion Criteria:\n\n* have a diagnosis of prostate cancer (stage I to IV);\n* be scheduled for a prostatectomy surgery (any surgical approach);\n* have no restriction to participate in at least mild levels of physical activity, as confirmed by the Physical Activity Readiness Questionnaire (PAR-Q+);\n* speak and understand English.\n* adult: 18 years of age or older\n* optional exercise component: willing and able to commit to the 12-week intervention\n\nExclusion Criteria:\n\n* have any medical conditions that may interfere with continence (i.e. neurological diseases);\n* have any contraindications to exercise testing or training;\n* have recent (\\>6 months) modifications to any medication aiming to reduce urinary incontinence (i.e. Myrbetric);\n* do not have regular access to the internet and a smart device or a computer at home\u002F at their community center;\n* are already receiving a pelvic floor exercise program through a pelvic floor physical therapist from their community.","MALE",{"count":214,"type":23},106,[216],"NA","The Continence, Sexual and Metabolic Health (CONTROL 4 LIFE) study will evaluate the recovery of continence, sexual function, and health outcomes in individuals who have undergone surgery for prostate cancer. The purpose of this study is to better understand the timelines of recovery for these outcomes after surgery for prostate cancer. As part of this study, all participants will receive resources offered by Alberta Health Services regarding pre- and post-prostatectomy care, including information on pelvic floor exercises. Through the CONTROL 4 LIFE study, the investigators will also be evaluating outcomes related to physical activity, fitness and quality of life. These assessments will enable the investigators to better understand how well and how long it takes for individuals to recover after surgery for prostate cancer.",[219,220,29],"Prostate Cancer","Incontinence","2026-08-11",{"date":195,"type":37},{"date":224,"type":37},"2024-02-27",{"date":226,"type":23},"2026-09-30",{"name":228,"class":229},"University of Alberta","OTHER",{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":17,"sex":238,"minAge":239,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":57,"phases":243,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":45},"100543581","continuous-glucose-monitoring-glycemic-characterization-during-pregnancy-100543581","NCT06357728","Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy","Integrated Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy in Comparison With OGTT (I-CHAP)","I-CHAP","Inclusion Criteria:\n\n1. Pregnant women of only Chinese or Indian ethnicity\n2. Pregnant women between age 21--45 years old\n3. Oral glucose tolerance test (OGTT) to be scheduled between 20-35 weeks gestational age\n4. OGTT to be done at KK Women's and Children's Hospital\n\nExclusion Criteria:\n\n1. Women with serious skin conditions (e.g. eczema) that precludes wearing the sensor for 10 days\n2. Exclusion criteria were pre-existing Type 1 or Type 2 diabetes, mental illness precluding informed consent and women who were diagnosed early (1st or early 2nd trimester for GDM).","FEMALE","21 Years","45 Years",{"count":242,"type":23},60,[216],"Our study named Integrated Continuous glucose monitoring glycemic cHAracterization during Pregnancy in comparison with oral glucose tolerance test (I-CHAP) aims to establish much needed preliminary evidence in our Asian population to show the capabilities of CGM use and its wealth of data for GDM diagnosis. This study aims to test the following aims and hypotheses in a single-armed intervention pilot trial study of pregnant women undergoing the oral glucose tolerance test:\n\nAim 1. To characterize CGM glucose values with the 3-point blood glucose measured during the OGTT procedure.\n\nThe investigators hypothesize that the CGM glucose values at single time points while fasted, and after the 75-g glucose load will be positively correlated with 3-timepoint blood glucose values captured during the OGTT.\n\nAim 2. To correlate the CGM glucose excursions and CGM-derived metrics (glycaemic variability and glycaemic control) with maternal-fetal outcomes and treatment outcomes.\n\nThe investigators hypothesize that higher AUC, glycemic variability and poorer glycaemic control will better distinguish maternal-fetal outcomes and treatment outcomes, compared to the OGTT.\n\nAim 3. To describe the acceptability of using the Dexcom G6 CGM as a diagnostic tool instead of the OGTT. The investigators hypothesize that a higher proportion of participants will report CGM to be more acceptable than the OGTT for GDM diagnosis.",[246,247,29],"Gestational Diabetes","Glucose Metabolism Disorders",[249,250,251],"gestational diabetes","pregnancy","continuous glucose monitoring","2026-08-05",{"date":254,"type":37},"2026-08-10",{"date":256,"type":37},"2024-07-01",{"date":258,"type":23},"2026-12-01",{"name":260,"class":261},"KK Women's and Children's Hospital","OTHER_GOV",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":57,"phases":271,"briefSummary":272,"conditions":273,"keywords":279,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":45},"100366758","phase-2-nautical-effect-of-natriuretic-peptide-augmentation-on-cardiometabolic-health-in-black-individuals-100366758","NCT04055428","NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals","The Effects of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals (NAUTICAL)","Inclusion Criteria:\n\n* Adults: Age more than or equal to 18 years of age\n* Self-identified race\u002Fethnicity as African-American or Black\n* Blood pressure: 120-160\u002F80-100 mmHg\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)\n* Have any past or present history of cardiovascular diseases (stroke, myocardial infarction, heart failure, transient ischemic attack, angina, or cardiac arrhythmia)\n* BP more than 160\u002F100 mmHg\n* BMI \\>45 kg\u002Fm2\n* History of diabetes or fasting plasma glucose \\>=126 mg\u002FdL or HbA1C\\>=6.5%\n* History of angioedema\n* Current or past (\\\u003C12 months) history of smoking\n* Estimated GFR \\\u003C 60 ml\u002Fmin\u002F1.73 m2; albumin-creatinine ratio ≥30 mg\u002Fg\n* Hepatic Transaminase (AST and ALT) levels \\>3x the upper limit of normal\n* Significant psychiatric illness or seizure disorder\n* More than 2 Alcoholic drinks daily\n* Anemia (men, Hct \\\u003C 38%, Hb\\\u003C13 g\u002FdL; women, Hct \\\u003C36%, Hb \\\u003C12 g\u002FdL)\n* Inability to exercise on a treadmill",{"count":270,"type":23},200,[60],"Black individuals are more likely to have decreased insulin sensitivity which results in a high risk for the development of cardiometabolic disease. The reasons for this are incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart that play a role in regulating the metabolic health of an individual. Low circulating level of NPs is an important contributor to increased risk for diabetes. The NP levels are relatively lower among Black individuals thus affecting their metabolic health and putting them at a higher risk for diabetes. This study aims to test the hypothesis that by augmenting NP levels using sacubitril\u002Fvalsartan, among Black Individuals one can improve their metabolic health (as measured by insulin sensitivity \\& energy expenditure) and help establish the role of NPs in the underlying mechanism behind increased risk for cardiometabolic disease in these population.",[80,274,275,29,276,277,278],"Cardiovascular Diseases","Insulin Sensitivity\u002FResistance","Natriuretic Peptides","Metabolism","Energy Expenditure",[276,280,281,278],"Diabetes","Insulin Sensitivity","2026-07-24",{"date":284,"type":37},"2026-07-28",{"date":286,"type":37},"2020-08-15",{"date":288,"type":23},"2027-05-31",{"name":290,"class":229},"University of Alabama at Birmingham",{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":298,"enrollmentInfo":299,"targetDuration":4,"studyType":57,"phases":301,"briefSummary":302,"conditions":303,"keywords":313,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":324},"100630707","phase-1-a-safety-and-tolerability-trial-evaluating-ctx310-in-participants-with-refractory-dyslipidemias-100630707","NCT07491172","A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias","A Phase 1 Open-label, Multicenter, First-in-human, Ascending Dose Trial Evaluating the Safety and Tolerability of a Lipid Nanoparticle Formulation of CRISPR-Guide RNA-Cas9 Nuclease (CTX310) for In Vivo Editing of the Angiopoietin-like 3 (ANGPTL3) Gene in Participants With Refractory Dyslipidemias","Key Inclusion Criteria:\n\n1. Age of ≥18 and ≤75 years at the time of signing the informed consent.\n2. Able to provide written informed consent.\n3. Participants diagnosed with persistent dyslipidemias defined by TG ≥150 mg\u002FdL - and LDL-C ≥70 mg\u002FdL in participants with ASCVD, or LDL-C ≥70 or 100mg\u002FdL in participants with or without ASCVD respectively, or TG ≥500 mg\u002FdL.\n4. Refractory to the maximal intensity or MTD of standard of care lines of lipid-lowering therapies available through routine clinical care, for at least 12 weeks prior to screening\n5. Female participants must be postmenopausal or surgically sterile.\n6. All male participants and their female partners must agree to the use of an acceptable method of effective contraception for the duration of the study.\n\nExclusion Criteria:\n\n1. Participants with familial chylomicronemia syndrome (FCS). Some exceptions may apply.\n2. Evidence of liver disease, defined as but not limited to:\n\n   LFTS \\>2 × upper limit of normal (ULN), or total bilirubin \\>2 × ULN, or INR \\>1.5 × ULN, or liver stiffness measured by liver elastography\n3. Abnormal or compromised function of kidney, heart, blood or liver.\n4. Acute coronary syndrome event or stroke within 24 weeks prior to Day 1. Acute pancreatitis within 12 weeks prior to Day 1.\n5. Current use or use within 365 days from Day 1 of any hepatocyte-targeted small interfering RNA (except inclisiran).\n6. Positive serology for HIV, hepatitis B or hepatitis C (antibody, surface antigen orNAT). Serology consistent with prior immunization will be eligible for the trial.\n7. Any prior malignancy within the past 5 years, or current malignancy (exceptions for resected or removed basal cell carcinoma, squamous cell carcinoma in situ and carcinoma in situ of the cervix or breast).\n8. Women of childbearing potential.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.\n\nNote: The inclusion and exclusion criteria listed represent the global protocol. Additional or modified eligibility criteria may apply in certain countries in accordance with local regulatory and ethics committee requirements and the approved country-specific protocol.","75 Years",{"count":300,"type":23},90,[59],"This is a single-arm, open-label, multicenter, ascending dose Phase 1 trial that will enroll participants 18 to 75 years of age with dyslipidemias that are refractory to available treatments.",[304,29,305,306,307,308,309,310,311,312],"Cardiovascular","Dyslipidemias","Lipid Disorder","Hypertriglyceridemia","Heterozygous Familial Hypercholesterolemia (HeFH)","Homozygous Familial Hypercholesterolemia (HoFH)","Severe Hypertriglyceridemia (sHTG)","Mixed Hyperlipemia","Hypercholesterolaemia",[314],"Refractory Dyslipidemias","2026-07-22",{"date":317,"type":37},"2026-07-23",{"date":319,"type":37},"2024-06-21",{"date":321,"type":23},"2028-06",{"name":323,"class":93},"CRISPR Therapeutics AG",19,{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":17,"sex":18,"minAge":101,"maxAge":102,"enrollmentInfo":332,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":334,"conditions":335,"keywords":338,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":348},"100277362","natural-history-physiology-microbiome-and-biochemistry-studies-of-propionic-acidemia-100277362","NCT02890342","Natural History, Physiology, Microbiome and Biochemistry Studies of Propionic Acidemia","The Natural History, Physiology, Microbiome and Biochemistry Studies of Propionic Acidemia","* INCLUSION CRITERIA:\n* Patients 2 years of age or older, of any gender and ethnicity, with propionic acidemia are eligible to enroll in this protocol. Patients diagnosis will be confirmed based on biochemical and\u002For molecular and enzymatic testing. Participants of any gender and ethnicity over 1 month of age are eligible to enroll remotely for collection of outside records and natural history data. They will be eligible to enroll in the full study for in-person evaluation at 2 years of age.\n* Unaffected family members over 1 month of age, of any ethnicity or race, may be included in the study as household controls for microbiome studies and\u002For for genetic analysis. Studies in unaffected family members may include collection of medical and family history; if necessary completion of physical examination; drawing of blood for research purposes include testing of DNA; collection of stool samples for microbiome studies; collection of dietary history using pen-and-paper or electronic food diary and questionnaires; collection of saliva for metabolite and DNA analysis. In some unaffected family members without a known familial cause of propionic acidemia, exome sequencing or genome sequencing could be performed. Unaffected family members will not receive direct benefit from taking part in the study.\n* If a participant becomes pregnant while on study, the participant can remain on study. The only way to learn more about the critical biological differences in those who affected with propionic acidemia who are pregnant is to continue to follow pregnant women on study.\n\nHowever, no tests or procedures that are greater then minimal risk will be performed. Affected subjects who are pregnant may undergo procedures as part of their clinical care, including blood draws, genetic studies, and consultations, according to the clinical judgement of the clinical team. However, pregnant participants will be excluded from procedures such as organ tissue collection, stable isotope studies, GFR testing, and brain or cardiac MRI until the pregnancy is concluded.\n\n* Healthy volunteers may be eligible to participate in the study if they are between 12 - 40 years of age, must meet specific BMI criteria (similar to affected individuals studied).\n* Patients with propionic acidemia over 1 month of age, of any gender and ethnicity, undergoing a transplantation surgery at Children s Hospital of Pittsburgh, are eligible to participate in the tissue collection arm of the study.\n\nEXCLUSION CRITERIA:\n\n* The PI\u002FAI may decline to enroll a patient because of poor metabolic control, lack of a primary metabolic\u002Fgenetics physician, and intercurrent infection are exclusion criteria for this protocol, the likelihood that an acutely ill or poorly controlled patient will enroll will be minimized.\n* A subset of participants may be enrolled in the tissue collection part of the study only (i.e. if they are too sick to travel). We can may also arrange limited remote consultation with our research team and NIH consultants, the participants referring physician and the participant\u002Ftheir legal guardian through the telephone or an NIH supported telehealth platform for participants who are unable to safely travel to NIH. This would not replace a study visit but would be used when travel isn t possible due to extenuating circumstances (e.g. pandemic). Participants would be encouraged to follow-up for a more thorough in-person evaluation when they are able to travel to NIH.\n* For the healthy volunteers, they will be excluded if they have halitosis, cavities, dental or gingival problems, respiratory diseases (for example, asthma or recent history of COVID19), use tobacco products (for example, cigarette smoking or chewing tobacco), or use electronic nicotine delivery systems (for example, use of e-cigarettes or vaping devices), as this may interfere with accurate measurement of their volatile organic compounds. NIH staff and their family members will be eligible to participate in the healthy volunteer portion of the study.",{"count":333,"type":23},1045,"Background:\n\nPeople s bodies need to break down food into the chemicals. These chemicals are used for energy and growth. Some people cannot process all chemicals very well. Too much of some chemicals can cause diseases. One of these diseases is called propionic acidemia (PA). People with PA can have problems with growth, learning heart, abdomen, and other organs. Researchers want to better understand how these problems happen.\n\nObjective:\n\nTo learn more about propionic acidemia and the genes that might contribute to it.\n\nEligibility:\n\nPeople at least 2 years old with PA who can travel to the clinic\n\nSome unaffected family members\n\nDesign:\n\nParticipants will have a 3 to 5-day hospital visit every year or every few years. Family members may have just 1 visit.\n\nDuring the family member visit, they may have:\n\nMedical history\n\nPhysical exam\n\nSamples of blood and urine\n\nQuestions about diet and a food diary\n\nDoctors and nurses may do additional studies:\n\nSamples of saliva, skin and stool\n\nFluid from a gastronomy tube, if participants have one\n\nDental and eye evaluations\n\nA kidney test - a small amount of dye will be injected and blood will be collected.\n\nConsultations with specialists\n\nA test of calories needed at rest. A clear plastic tent is placed over the participant to measure breathing.\n\nStable isotope study. Participants will take a nonradioactive substance then blow into a bag.\n\nPhotos taken of the face and body with underwear on\n\nUltrasound of the abdomen\n\nHeart tests\n\nHand x-ray\n\nBrain scan\n\nParticipants may have other tests if study doctors recommend them. They will get the results of standard medical tests and genetic tests.",[29,336,337],"Propionic Acidemia","Organic Acidemia",[337,339,32],"Inborn Errors of Metabolism","2026-07-18",{"date":342,"type":37},"2026-07-21",{"date":344,"type":37},"2016-11-29",{"date":346,"type":23},"2036-08-31",{"name":143,"class":44},2,{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":238,"minAge":19,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":57,"phases":357,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":348},"100472513","impact-of-metabolic-health-patterns-and-breast-cancer-over-time-in-women-100472513","NCT05432856","Impact of Metabolic Health Patterns And Breast Cancer Over Time in Women","IMPACT-Women","Inclusion Criteria:\n\n* Female biological sex at birth\n* \\>18 years\n* Diagnosis of stage I, II, or III breast cancer\n* starting neoadjuvant or adjuvant intravenous chemotherapy\n* ECOG \\\u003C3;\n* Oncologist approval to participate;\n* English speaking (all study materials and study staff will be in English)\n* Willing and able to adhere to study intervention\n\nExclusion Criteria:\n\n* Individuals who do not have access to a smart phone with Bluetooth capability (required for Fitbit and for responding to intervention text messages) or at least a shared cell phone with someone in the same household (i.e., some couples may share a phone).\n* Type 1 or type 2 diabetes who require exogenous insulin (due to the potential need to adjust insulin dosing with TRE) or with hemoglobin A1c \\>10%\n* Research MRI contraindications (e.g., pacemaker, magnetic implants, pregnancy)\n* Uncontrolled thyroid disorder\n* Self-reported eating disorder history\n* Body mass index \\\u003C18.5 kg\u002Fm2 or clinical signs of cachexia (discretion of treating oncologist)\n* ≥5% body weight loss within last 6 months\n* Those who are currently working night\u002Frotating shifts, eating within ≤10-hour window or consistently eating less than 3 meals\u002Fday in the past 3 months.\n* patients who meet the criteria for medical clearance prior to exercise using the Physical Activity Readiness Questionnaire+ and are not cleared by their treating oncologist or family physician to perform maximal exercise testing.",{"count":5,"type":23},[216],"Background \\& Rationale:\n\nBreast cancer (BC) is the most commonly diagnosed malignancy in women worldwide (2.1 million diagnoses in 2018, 25% of new cancer cases). In Canada, early stage BC mortality rates have decreased by 48% over the past 30 years as a result of advances in prevention, detection, and treatment. However, competing risks for mortality from non-cancer causes have emerged, where cardiovascular disease (CVD) is now a leading cause of death for BC survivors. The direct toxic effects of BC treatment on the heart (cardiotoxicity) are well characterized by the investigators and many others, as a contributor to elevated cardiovascular risk. However, BC treatment and the associated lifestyle changes (i.e. physical inactivity, poor diet quality, stress) are increasingly recognized to also strongly affect metabolism negatively manifesting as insulin resistance, dyslipidemia and adipose tissue (fat) accumulation. These adverse metabolic changes are strongly linked to CVD risk and represent a currently underappreciated contributor to the elevated CVD risk among BC survivors. Preliminary data and recent publications demonstrate that regional fat accumulation occurs during BC treatment and that the fat burden in key locations is associated with poor cardiorespiratory health. A trigger of these adverse metabolic and inflammatory effects is excess fat specifically within ectopic fat (viscera, intermuscular, or hepatic) regions. In 2019, a member of the study team found that the volume of visceral and intermuscular but not subcutaneous fat at BC diagnosis were linearly associated with CVD events within 6 years, even among those with normal BMI and after adjustment for pre-existing CVD risk factors and for BC treatment type. Using MRI, investigators found that \\~1 year after chemotherapy, BC survivors had significantly larger depots of visceral fat (49% larger) and thigh intermuscular fat (41% larger) compared to age and sex-matched controls, despite similar BMI and subcutaneous fat volumes in the two groups. Investigators also showed that the fat fraction within the thigh muscle and visceral fat volumes independently explained \\~50% of the variation in cardiorespiratory fitness (measured by peak VO2). In particular, peak VO2 is one of the most powerful predictors of all-cause and CVD mortality and health care costs, and is the most consistently reported negative sequelae after treatment for BC. Unfortunately, there are no known therapies to recover long-term myocardial damage (i.e. cell death, fibrosis) from cancer therapies. There are several reasons to target fat as a therapeutic target in BC patients: 1) The study team have compelling preliminary data showing accelerated formation of ectopic fat during BC treatment. 2) Investigator's recent data showed that high fat content in key fat pools was associated with reduced peak VO2. 3) The burden of fat and the associated metabolic abnormalities are dynamic and malleable, and thus highly treatable.\n\nResearch Question \\& Objectives:\n\nThe primary purpose of this study is to evaluate the effect of a behavioural intervention involving supported time-restricted eating (TRE), diet quality improvements, and reduced sedentary time versus usual cancer and nutrition care in BC patients receiving chemotherapy treatment on ectopic fat, cardiometabolic profile, and chemotherapy outcomes. The investigators hypothesize that the intervention will attenuate the growth of ectopic fat during chemotherapy and reduce chemotherapy symptoms.",[274,360,29],"Cardiovascular Morbidity","2026-07-16",{"date":363,"type":37},"2026-07-20",{"date":365,"type":37},"2024-03-13",{"date":367,"type":23},"2028-12",{"name":228,"class":229},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":17,"sex":18,"minAge":376,"maxAge":19,"enrollmentInfo":377,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":45},"100516659","understanding-metabolism-and-inflammation-risks-for-diabetes-in-adolescents-100516659","NCT06007404","Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents","The Role of Circulating Meta-Inflammatory Monocytes in Adolescent Insulin Resistance","Inclusion Criteria:\n\n* Between 14 and 18 years of age\n* Tanner stage 4 or 5 (mature adult stage of puberty)\n* Normal weight (BMI ≥ 5th percentile \\& \\\u003C 85th percentile), overweight (BMI \\> 86th percentile) \\& \\\u003C 94th percentile), obese weight (BMI percentile ≥ 95th percentile), and\u002For pre-diabetes (HbA1c \\> 5.7%)\n* For Type 2 Diabetes cohort, diagnosis of Type 2 Diabetes\n\nExclusion Criteria:\n\n* Currently pregnant\n* Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids), unless prescribed for Type 2 Diabetes management\n* Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability that would inhibit following directions of study staff\n* Allergies or intolerance to milk, soy, or palm oil","14 Years",{"count":378,"type":23},175,"This research study collects health-related information and blood samples to better understand how body composition, lifestyle habits, and diet influence meta-inflammatory monocytes (MiMos) in adolescents. The hypothesis of this study is that adolescents at risk for metabolic disease have enhanced MiMo related activities leading to insulin resistance.",[381,382,156,29,383],"Type 2 Diabetes","Insulin Resistance","PreDiabetes","2026-07-10",{"date":386,"type":37},"2026-07-13",{"date":388,"type":37},"2023-09-06",{"date":390,"type":23},"2027-09",{"name":392,"class":229},"University of Michigan",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":400,"enrollmentInfo":401,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":402,"conditions":403,"keywords":406,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":45},"100470053","metabolic-and-infectious-diseases-in-la-runion-the-reunion-population-based-study-100470053","NCT05400824","Metabolic and Infectious Diseases in La Réunion (the REUNION Population-based Study)","Pathologies métaboliques et Infectieuses en Population générale à La Réunion : étude REUNION","Inclusion Criteria:\n\n* 18-67 years\n* given consent for genetic analysis,\n* written consent for participating in the study\n\nExclusion Criteria:\n\n* judicial protection or guardianship","67 Years",{"count":22,"type":23},"The aim of the present study is to determine the prevalence of cardiometabolic and infectious disease in La Reunion (french oversea department and region of France).\n\nKnown or suspected risk factor for these diseases will also be assessed, such as microbiota, cognitive impairement, social inequalities, and genetics.",[404,274,405,29],"Infectious Disease","General Population",[407,408,409,410,411,412,413,414,415],"epidemiology","risk factors","prevalence","cognitive impairment","dengue","hypertension","dyslipidemia","social inequalities","autonomous nervous system","2026-07-09",{"date":384,"type":37},{"date":419,"type":37},"2022-05-01",{"date":421,"type":23},"2027-12",{"name":423,"class":261},"Institut National de la Santé Et de la Recherche Médicale, France",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":239,"enrollmentInfo":431,"targetDuration":4,"studyType":57,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":443,"locationsCount":45},"100394283","phase-2-tcr-alpha-beta-t-cell-depleted-haploidentical-hct-in-the-treatment-of-primary-immunodeficiency-and-inherited-metabolic-disorders-in-children-100394283","NCT04414046","TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Primary Immunodeficiency and Inherited Metabolic Disorders in Children","Study of TCR Alpha Beta T-Cell and CD19 B-Cell Depletion for Hematopoietic Cell Transplantation From Haploidentical Donors in the Treatment of Primary Immunodeficiency and Inherited Metabolic Disorders in Children","Inclusion Criteria:\n\n1. Patient with any form of primary immune deficiency\u002Fdysregulatory disorders characterized by aberrant immune function, abnormal hematopoiesis, systemic or organ specific autoimmunity and\u002For non-malignant lymphoproliferation. This includes, but not limited to:\n\n   I. Disorders of phagocytes: Chronic granulomatous disease, Leukocyte adhesion deficiency, defects of IL-10 pathway, MonoMac syndrome\n\n   II. Defects of cellular and humoral immunity: Severe Combined Immunodeficiency Disorder (infants with classic SCID up to 2 years of age will be excluded due to other open protocol), X-linked hyper-IgM syndrome, DOCK8 deficiency, ZAP70 deficiency, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, NEMO deficiency.\n\n   III. Disorder of immune dysregulation: Immunodysregulation polyendocrinopathy enteropathy X-linked (IPEX) syndrome, CTLA4 deficiency, LRBA deficiency, STAT1 GOF, STAT3 GOF, X-linked lymphoproliferative disease etc.\n\n   IV. Other PIDs and immune dysregulatory disorders who can be benefitted by HCT as deemed appropriate by the PI and the treating immunologist.\n2. Histiocytic disorders including hemophagocytic lymphohistiocytosis (familial HLH (types 1-5), secondary HLH (refractory to therapy or with recurrent episodes of hyper inflammation) and multisystem refractory Langerhans cell histiocytosis.\n3. Metabolic disorders that could improve or stabilize after stem cell transplantation such as mucopolysaccharidoses, neurodegenerative disorders, osteopetrosis, etc.\n\nInclusion Criteria:\n\n1. Patient has a suitable genotypic identical match of 5\u002F10. The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-C, HLA-DRB1 and HLA-DQB1.\n2. Patients must have adequate organ function measured by:\n\n   1. Cardiac: asymptomatic or if symptomatic then LVEF at rest must be ≥ 40% or SF ≥ 26%\n   2. Pulmonary: asymptomatic or if symptomatic DLCO ≥ 40% of predicted (corrected for hemoglobin) or pulse oximetry ≥ 92% on room air if the patient is unable to perform pulmonary function testing.\n   3. Renal: Creatinine clearance (CrCl) or glomerular filtration rate (GFR) must be \\> 50 mL\u002Fmin\u002F1.73 m2.\n   4. Hepatic: Serum conjugated (direct) bilirubin \\\u003C 2.0 x ULN for age; AST and ALT \\\u003C 5.0 x ULN for age.\n   5. Karnofsky or Lansky (age-dependent) performance score ≥ 50\n3. Signed written informed consent\n\nExclusion Criteria:\n\n1. Participants who have an HLA-matched sibling who is able and willing to donate bone marrow. Patients with a HLA-matched unrelated donors are not excluded.\n2. Pregnant or breastfeeding females.\n3. Patient has HIV or uncontrolled fungal, bacterial or viral infections.\n4. Patient has received prior solid organ transplant.\n5. Patient has active GVHD (\\> grade II) or chronic extensive GVHD due to a previous allograft at the time of inclusion.",{"count":432,"type":23},17,[60],"This research is being done to learn if a new type of haploidentical transplantation using TCR alpha beta and CD19 depleted stem cell graft from the donor is safe and effective to treat the patient's underlying condition. This study will use stem cells obtained via peripheral blood or bone marrow from parent or other half-matched family member donor. These will be processed through a special device called CliniMACS, which is considered investigational.",[436,29],"Primary Immune Deficiency Disorders","2026-06-29",{"date":439,"type":37},"2026-07-01",{"date":441,"type":37},"2020-07-22",{"date":90,"type":23},{"name":444,"class":229},"Johns Hopkins All Children's Hospital",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":453,"conditions":454,"keywords":455,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":45},"100559153","cardiovascular-and-metabolic-sciences-biorepository-100559153","NCT06560424","Cardiovascular and Metabolic Sciences Biorepository","Inclusion Criteria:\n\n* Willing and able to sign the informed consent document\n\nExclusion Criteria:\n\n* Chronic anemia (hemoglobin consistently \\\u003C9 g\u002FL)",{"count":452,"type":23},10000,"The purpose of the Cardiovascular and Metabolic Sciences Biorepository is to collect and store information and biospecimens (blood, urine, stool, and heart tissue) from patients with and without cardiovascular and metabolic diseases to create a readily available biorepository of samples and related medical health information to expedite future research into the causes and consequences of cardiovascular and metabolic diseases.",[274,29],[456],"Biorepository","2026-06-23",{"date":459,"type":37},"2026-06-25",{"date":461,"type":37},"2024-09-18",{"date":463,"type":23},"2050-12-31",{"name":465,"class":229},"The Cleveland Clinic",{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":57,"phases":475,"briefSummary":476,"conditions":477,"keywords":491,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":509,"locationsCount":348},"100526751","effect-of-endoscopic-sleeve-gastroplasty-in-patients-with-obesity-and-mash-a-randomized-controlled-trial-100526751","NCT06138821","Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial","Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 (male or female)\n2. BMI ≥30 kg\u002Fm2 or ≥27 kg\u002Fm2 with at least one obesity-related comorbidity\n3. Self-reported stable weight (no weight change \\>5%) for 6 months prior to the first study visit\n4. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory\u002Fimaging\u002Fadditional tests, and completing diet counseling\n5. Willingness to NOT start a new anti-obesity medication for the following 12 months\n6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits\n7. Ability to give informed consent\n8. Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods\n\nExclusion Criteria:\n\n1. Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)\n2. Treatment with vitamin E (at doses ≥800 IU\u002Fday), pioglitazone, obeticholic acid, or resmetirom \\\u003C90 days before the first study visit\n3. History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)\n4. Prior bariatric surgery\n5. Prior endoscopic sleeve gastroplasty\n6. Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease\n7. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses\n8. Severe gastroesophageal reflux disease (GERD)\n9. A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.\n10. Achalasia or any other severe esophageal motility disorder\n11. Chronic abdominal pain\n12. Gastroparesis or intractable constipation\n13. Hepatic insufficiency or cirrhosis\n14. Severe coagulopathy\n15. Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 12%\n16. Patients on an anti-platelet agent, anticoagulant agent or chronic\u002Froutine use of NSAIDs\n17. Patients on corticosteroids, immunosuppressants, or narcotics\n18. Patients on an anti-seizure or anti-arrhythmic medication\n19. Patients who are pregnant or breastfeeding\n20. Excessive alcohol consumption (\\>20 g per day for women; \\>30 g per day for men)\n21. Active smoking\n22. History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia\n23. History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer\n24. History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease\n25. History of active malignancy\n26. History of genetic or hormonal causes for obesity, such as Prader Willi syndrome\n27. History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism\n28. Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating\n29. Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist",{"count":474,"type":23},132,[216],"Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD\u002Fmetabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery.\n\nOver the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown.\n\nIn this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.",[156,478,479,480,481,482,483,484,485,382,281,275,29,280,486,487,488,489,490],"Liver Diseases","Liver Fibrosis","Liver Fat","Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis","MASLD","MASH","Weight Loss","Diabetes Mellitus, Type 2","NASH With Fibrosis","Non-Alcoholic Fatty Liver Disease","Non Alcoholic Fatty Liver","Non-alcoholic Steatohepatitis",[492,493,494,495,496,497,498,499,500,501,502,503,504],"Gut Hormones","Endoscopic Bariatric and Metabolic Therapy (EBMT)","Intragastric Balloon (IGB)","Endoscopic Suturing","Endoscopic Sleeve Gastroplasty (ESG)","Weight Management","Endoscopic Gastric Remodeling (EGR)","Endoscopic Bariatric Therapy (EBT)","Fatty Liver","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Non-Alcoholic Fatty Liver Disease (NAFLD)","Non-Alcoholic Steatohepatitis (NASH)",{"date":459,"type":37},{"date":507,"type":37},"2025-06-24",{"date":321,"type":23},{"name":510,"class":229},"Pichamol Jirapinyo, MD, MPH",{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":4,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":212,"minAge":19,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":57,"phases":520,"briefSummary":521,"conditions":522,"keywords":525,"overallStatus":531,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":45},"100560671","theoretically-informed-behavioral-intervention-100560671","NCT06580184","Theoretically Informed Behavioral Intervention","Theoretically Informed Behavioral Intervention to Prevent HIV-related Comorbidities","Inclusion Criteria:\n\nSelf-identify as:\n\n* living with HIV\n* English speaking\n* Access to a device compatible with LEARN 2\n\nExclusion Criteria:\n\n\\- medical history of serious complications such as heart attack, stroke, cognitive impairment, or cancer.",{"count":519,"type":23},164,[216],"The goal of this waitlist control clinical trial is to learn if the tailored LEARN 2 platform can prevent HIV-related comorbidities with shared risk factors in men ages 18 and older living with HIV. The main question\\[s\\] are:\n\n1. Can the virtual environment improve quality of life among these participants?\n2. Does the LEARN 2 platform effectively serve as prevention education for HIV comorbidity shared risk factors?\n\nResearchers will compare participants receiving the LEARN2 virtual environment intervention to those in a waitlist control group to see if the intervention leads to improvements in quality of life and reductions in risk factors.\n\nParticipants will be asked to:\n\n1. Engage with the virtual environment weekly.\n2. Participate in virtual live health educator sessions.\n3. Complete daily assessments of personal health behaviors through Ecological Momentary Assessment.",[523,524,29],"HIV","CVD",[526,523,524,527,80,528,529,530],"Syndemic","HTN","Cancer","Virtual Reality","Prevention","NOT_YET_RECRUITING","2026-06-12",{"date":534,"type":37},"2026-06-16",{"date":536,"type":23},"2026-10",{"date":538,"type":23},"2029-03-31",{"name":540,"class":229},"Yale University",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":548,"enrollmentInfo":549,"targetDuration":4,"studyType":57,"phases":551,"briefSummary":552,"conditions":553,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":559,"locationsCount":45},"100625014","phase-1-assess-the-safety-and-tolerability-of-sns851-in-healthy-participants-100625014","NCT07417124","Assess the Safety and Tolerability of SNS851 in Healthy Participants","A First-in-Human Study to Assess the Safety and Tolerability of Single and Multiple Doses of SNS851 in Healthy Participants","Inclusion Criteria:\n\n1. Able to provide written informed consent. Willing, committed, and able to return for all clinic visits and complete all protocol specified procedures.\n2. Healthy male or female, aged between 18 and 55 years, inclusive at screening.\n3. Body mass index (BMI) of greater than or equal to 18 kg\u002Fm2 and lesser than or equal to 32 kg\u002Fm2 at Screening.\n4. Negative human immunodeficiency virus, viral hepatitis B and C serology at Screening.\n5. No major changes in diet, alcohol intake, or physical activity within 4 weeks before dosing and no intention to modify during confinement or follow-up.\n6. No acute illness in the 4 weeks prior to check-in, as established by physical examination and medical history.\n7. Participant is willing to refrain from consuming caffeine and\u002For xanthene products (e.g., coffee, tea, chocolate, and caffeine-containing sodas, colas) for 12 hours before each study visit and while being confined to the study site.\n8. All participants of reproductive potential must use a highly effective contraceptive method from consent through 90 days after last dose.\n\nExclusion Criteria:\n\n1. Weight loss of more than 10% within the last 3 months prior to screening.\n2. Has any clinical safety laboratory result considered clinically significant by the Investigator (or designee)\n3. In the opinion of the PI (or designee), has evidence of other forms of known chronic liver disease\n4. Participants with history or pre-existing renal disease\n5. Relevant history (in the opinion of the PI or designee) of cardiac arrythmias including long QT syndrome, sudden cardiac death, or Torsades de Pointes and\u002For syncope and\u002For clinically significant cardiovascular event or history of uncontrolled hypertension or orthostatic hypotension within the last 6 months prior to the Screening Visit.\n6. QTcF interval duration \\> 450 msec for male or \\> 470 msec for female at Screening or Day 0.\n7. Evidence or history of clinically significant pulmonary and respiratory diseases, including any clinically significant pulmonary disease or sequelae of COVID-19 infection that may increase risk from study participation.\n8. Use of an investigational agent or device within 30 days or 5 half-lives since last dose of prior investigational product or device of Day 1 drug administration in this trial, whichever is longer prior to dosing or current participation in an investigational study.\n9. History of having received long-duration RNA-based therapies within 12 months of Day 1.\n10. Use of any prescription medication or concomitant medications within 14 days prior to the first dose of study drug, or use of over-the-counter medication\u002Fvitamins\u002Fsupplements within 7 days prior to the first dose of study drug. Exceptions include contraception, iron supplements for participants who have ferritin between 15-30 µg\u002FL at screening, occasional paracetamol (up to a maximum of 2 grams per day).\n11. Use of any vaccinations within 14 days prior to the first study drug administration.\n12. Use of anabolic steroids and systemic treatment with glucocorticosteroids within 3 months prior to the Screening Visit.\n13. History of substance dependence (within the last 12 months) or positive urine drug screen at screening or positive alcohol breath tests at screening.\n14. Urinary cotinine levels at screening are indicative of smoking or participant has a history of regular use of tobacco- or nicotine-containing products.\n15. Any clinically significant illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the first administration of study intervention.\n16. In the opinion of the PI (or designee), has an aversion to, or has history of site reactions to Subcutaneous administrations that would make them unsuitable for inclusion in this trial.\n17. Has donated blood or blood products within 3 months prior to first dose administration.\n18. Presence or evidence of recent sunburn, scar tissue, tattoo, open sore or branding that, in the opinion of the PI or medically qualified designee, would interfere with the interpretation of skin adverse reactions at the injection site\n19. In the opinion of the PI (or designee), has any uncontrolled or serious disease, medical or surgical condition that may interfere with participation or data interpretation.\n20. Any other condition or prior therapy that in the opinion of the PI (or designee) would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.\n21. History of hypersensitivity to oligonucleotide therapeutics or injection-site reactions.","55 Years",{"count":550,"type":23},52,[59],"This is a Phase I, randomized, double-blind study designed to evaluate the safety, tolerability and pharmacokinetics of subcutaneous administration of SNS851 in healthy participants.",[29],"2026-06-10",{"date":532,"type":37},{"date":557,"type":37},"2026-04-01",{"date":536,"type":23},{"name":560,"class":93},"Oneness Biotech Co., Ltd.",{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":212,"minAge":567,"maxAge":568,"enrollmentInfo":569,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":570,"conditions":571,"keywords":574,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":45},"100485428","characterization-of-dysmorphology-in-subjects-with-creatine-transporter-deficiency-100485428","NCT05600946","Characterization of Dysmorphology in Subjects With Creatine Transporter Deficiency","* INCLUSION CRITERIA:\n\n  1. Patient is male and between 2-40 years of age, inclusive.\n  2. Patient has genomic confirmation of a pathologic mutation in the SLC6A8 gene.\n  3. Patient is able to complete study-related procedures within limitations imposed by condition under study.\n  4. Patients parents\u002Fguardians\u002Fcaregivers must provide written consent (informed consent) to study-related procedures, and if appropriate, the patient will provide an assent.\n\nEXCLUSION CRITERIA:\n\n1. Patient has had status epilepticus within 3 months of screening.\n2. Patients has had a seizure that lasts 5 minutes or longer, and a second seizure without recovering consciousness from the first one, or if a person has repeated seizures for 30 minutes or longer.\n3. Patient is unable to comply with the study procedures or has a clinical disease or laboratory abnormality that in the opinion of the investigator would potentially increase the risk of participation.","2 Years","40 Years",{"count":324,"type":23},"Background:\n\nCreatine transporter deficiency (CTD) is a genetic disorder that mainly affects the brain in males. CTD causes intellectual disability that can be mild to severe. People with CTD may have seizures and behavioral issues. They may have slow growth and tire easily. CTD may sometimes be confused with autism or other disorders. Better diagnostics are needed. The study team in an NIH study noted that the faces of children with CTD can look similar. For this natural history study, an expert will examine photos of children with CTD. Any shared traits found might help to diagnose CTD.\n\nObjective:\n\nTo look for shared facial features of children with CTD.\n\nEligibility: Males aged 2 to 40 years old with CTD who were in study 17-CH-0020.\n\nDesign:\n\nSome participants in study 17-CH-0020 had pictures taken of their faces. The NIH study team wants to share these photos with a colleague in Canada. This person is an expert at evaluating how genetic disorders affect people s bodies.\n\nParticipant data collected during the study may also be sent to this expert. This data may include diagnostic images and results from lab tests.\n\nSome children did not have their pictures taken during study 17-CH-0020. Parents are asked to take pictures of these children and send them to the study team. These photos can be sent to a secure portal. The photos can also be taken in-person during a clinic visit.\n\nThe photos may be printed in clinical study journals. But this is not required. Parents will be asked to sign a separate consent before the photos are published....",[572,29,573],"Cognitive Disorder","Autism Spectrum Disorder",[575,573,576,32],"Developmental Delay","Children","2026-06-03",{"date":579,"type":37},"2026-06-04",{"date":581,"type":37},"2022-10-24",{"date":583,"type":23},"2026-09-01",{"name":203,"class":44},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":568,"enrollmentInfo":592,"targetDuration":4,"studyType":57,"phases":594,"briefSummary":595,"conditions":596,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":45},"100424854","exercise-effects-on-adipose-tissue-structure-and-function-100424854","NCT04812314","Exercise Effects on Adipose Tissue Structure and Function","LG","Inclusion Criteria:\n\n* Age: 18-40\n* Body Mass Index: 27-45 kg\u002Fm2\n* No regularly planned exercise\u002Fphysical activity for at least 6 months\n* Women must have regularly occurring menses and must be premenopausal\n\nExclusion Criteria:\n\n* Evidence\u002Fhistory of cardiovascular or metabolic disease\n* Medications known to affect lipid or glucose metabolism, or inflammation\n* Weight instability ≥ ± 6 pounds in the last 3 months\n* Tobacco or e-cigarette users\n* Women must not be pregnant or actively lactating",{"count":593,"type":23},46,[216],"Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.",[156,597,29,382,485,598],"Metabolic Syndrome","Weight Gain","2026-06-02",{"date":579,"type":37},{"date":602,"type":37},"2021-03-01",{"date":604,"type":23},"2030-03-01",{"name":392,"class":229},{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":614,"conditions":615,"keywords":616,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":175},"100377426","signature-of-the-risk-profile-of-mortality-in-a-hospital-cohort-of-patients-with-metabolic-diseases-100377426","NCT04194372","Signature of the Risk Profile of Mortality in a Hospital Cohort of Patients With Metabolic Diseases","INTEGRA","Inclusion Criteria:\n\n* Diabetic: antecedent - treatment - or glycemia\\> = 1.26 g \u002F dl - or HbA1C\\> = 6.5% and or\n* Obese: BMI\\> = 30 and or\n* Metabolic syndrome defined AND\n* Patient having given written consent to participate in the study or collection of the consent of the witness\n* Social insured patient (excluding AME)\n* Patient willing to comply with all procedures of the study and its duration AND\n\nPatient also presenting a pathology among:\n\n* Cardiology:\n\n  * Coronary patient(history of myocardial infarction, coronary bypass, or coronary angioplasty or stenosis greater than 50% on an epicardial vessel documented on coronary angiography)\n  * Patient with systolic or diastolic heart failure\n  * Patient with atrial fibrillation\n  * Patient with aortic stenosis (Vmax\\> 2.5 m \u002F s)\n  * Patient with high blood pressure\n* neurology:\n\n  * ischemic stroke\n  * intracerebral hemorrhage\n  * transient ischemic attack\n* diabetology:\n\n  * Obesity without diabetes\n  * Diabetes T2\n  * T1 diabetes\n  * Monogenic Diabetes \u002F MODY\n  * African Diabetes\n  * Diabetes secondary to pancreatopathy \u002F liver cirrhosis\n  * Diabetes post transplantation \u002F post immunotherapy\n  * Diabetes associated with Steinert's disease\n* hepatology: hepatological pathology\n* nephrology: nephrology\n\nExclusion Criteria:\n\n* Unscheduled hospitalization less than 3 months old\n* Ongoing treatment :\n\n  * Cytotoxic chemotherapy\n  * Radiotherapy\n* HIV and \u002F or HCV and \u002F or active HBV infection\n* OMS score\\> = 2\n* Pregnant woman",{"count":452,"type":23},"Epidemiological studies are usually conducted in the general population in adults without complications or pathology at baseline. The results obtained are therefore often better designed for primary prevention use. The prediction of mortality risk in patients with complications and requiring hospital follow-up is less well known.\n\nThe study purpose is to determine a mortality risk profile in a hospital cohort of patients with pathologies associated with metabolic diseases.\n\nToday the \"multimaker\" scores based on a panel of biomarkers - have significantly improved the discriminating power of prediction models existing in many pathologies. It is no longer a single biomarker that can improve risk prediction but a complete and cross-sectional profile that is sought after. We aim to establish a personalised mortality risk profile by combining clinical and biological parameters including metabolomics, genetics, transcriptomics and epigenomics by high throughput screening of biological samples.",[29],[617,618,619,620],"Diabetic","CardioVascular Disease","morbi-mortality","Hospital Cohort","2026-05-20",{"date":623,"type":37},"2026-05-22",{"date":625,"type":37},"2019-12-20",{"date":627,"type":23},"2030-01",{"name":629,"class":229},"University Hospital, Lille",{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":4,"eligibilityCriteria":636,"healthyVolunteers":17,"sex":18,"minAge":568,"maxAge":637,"enrollmentInfo":638,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":640,"conditions":641,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":45},"100445218","alzheimers-imaging-biomarkers-in-obesity-100445218","NCT05077579","Alzheimer\"s Imaging Biomarkers in Obesity","Neuroinflammation and Alzheimer's Disease Imaging Biomarkers in Midlife Obesity","Inclusion Criteria:\n\n1. Male and female, 40-60 years of age and any race;\n2. MMSE = or greater than 25 or a Clinical Dementia Rating Scale (CDR)=0;\n3. Willing and able to undergo MRI\n4. Willing to complete PET scans, including \\[11C\\]PiB and 18F-AV-1451 (Flortaucipir) radioactive tracer injection under protocols IRB #201409014 \\& 201906028\n5. Willing to participate in the metabolic subtyping of metabolically normal or abnormal overweight or obese status for the following three groups:\n\n   a. Group 1: MAOO criteria: i. BMI ≥25 but \\\u003C45 kg\u002Fm2; ii. Maximum body circumference \\\u003C 165 cm to ensure participants fit into the PET\u002FCT and MR scanners; iii. Fasting blood glucose: ≥100 mg\u002Fdl or blood glucose 2 h after an OGTT: ≥140 or fasting insulin: \\>20 µu\u002Fml;\n\n   b. Group 2: MNOO criteria: i. BMI ≥ 25 but \\\u003C45 kg\u002Fm2; ii. Maximum body circumference \\\u003C 165 cm to ensure participants fit into the PET\u002FCT and MR scanners; iii. Blood glucose 2 h after an OGTT: iv. HbA1c \\\u003C 5.7% v. Fasting insulin: \\\u003C 20 µu\u002Fml;\n\n   c. Group 3: MNLP criteria: i. BMI ≥18.5 but \\\u003C 25.0 kg\u002Fm2; ii. Maximum body circumference \\\u003C 165 cm to ensure subjects fit into the PET\u002FCT and MR scanners; iii. Fasting blood glucose: \\\u003C 100 mg\u002Fdl; iv. Blood glucose 2 h after an OGTT: \\\u003C 140 mg\u002Fdl; v. HbA1c \\\u003C 5.7% vi. Fasting insulin: \\\u003C 20 µu\u002Fml;\n\nExclusion Criteria:\n\n1. Any condition that in the opinion of the Investigator or designee could increase the risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with the collection of the data, (e.g., currently taking a drug for treatment of obesity);\n2. Intend to have bariatric surgery;\n3. Inability to tolerate to lie still during the scanning procedures (e.g., severe, chronic back pain);\n4. Severe claustrophobia;\n5. Women who are currently pregnant or breast-feeding;\n6. Currently receiving an active obesity study drug (or placebo) or in an obesity clinical trial;\n7. Laboratory Evaluations exclusion: • Oral glucose tolerance test should not be performed in patients who already fulfill the criteria for diabetes mellitus. These include: - History of Type 1 or 2 diabetes mellitus - Prior documentation of a fasting plasma glucose \\>7.0 mmol\u002FL or two or more occasions or clinical symptoms of diabetes e.g. polydipsia, polyuria, ketonuria and rapid weight loss with a random plasma glucose of \\>11.1 mmol\u002FL • Other contraindications for venous access as part of OGTT or blood draws: - Venous fibrosis or shunt grafts in both upper extremities - Ongoing cellulitis or infection, particularly in the upper extremities. - Presence of a hematoma at the site of vascular access. - History of hypoglycemic encephalopathy that can occur with prolonged fasting\n8. MRI exclusion: • Contraindications to MRI (e.g., certain incompatible electronic medical devices that make it potentially unsafe for the individual to participate). All participants must be willing to undergo at least two MRI screenings, supervised by Level II MRI personnel as designated by the American College of Radiology (ACR).","60 Years",{"count":639,"type":23},240,"High body fat at midlife, as evidenced by overweight or obese body mass index (BMI), is increasingly understood as a risk factor for Alzheimer's disease. However, the underlying processes and mechanisms that may underlie this risk remains unknown. With this project, the Investigator proposes to create a new cohort of cognitively normal 120 midlife individuals, age 40-60 years. The investigator and research staff will characterize the participant's overweight or obese status using metabolic tests including, an oral glucose tolerance test, fasting plasma insulin, fasting plasma glucose, and hemoglobin A1c measurements. This testing will generate categories of metabolically abnormal overweight and obese (MAOO), metabolically normal overweight and obese (MNOO), and metabolically normal lean participants (MNLP). Research staff will evaluate differences between these groups on neuroimaging with the newer classification framework of Alzheimer's biomarkers with amyloid (A), tau (T), and neurodegeneration (N), or ATN. Neurodegeneration will be assessed by atrophy on brain MRI as reflected by regional volumes on Freesurfer. Staff will also evaluate MR neuroimaging markers for neuroinflammation using a newer method called diffusion basis spectrum imaging (DBSI), developed at the Mallinckrodt Institute of Radiology at Washington University in St. Louis in collaboration with The Charles F. and Joanne Knight Alzheimer's Disease Research Center (Knight ADRC).",[642,156,29],"Alzheimer Disease","2026-05-07",{"date":645,"type":37},"2026-05-11",{"date":647,"type":37},"2021-10-18",{"date":649,"type":23},"2027-12-31",{"name":651,"class":229},"Cyrus A Raji",{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":656,"acronym":657,"eligibilityCriteria":658,"healthyVolunteers":17,"sex":238,"minAge":659,"maxAge":660,"enrollmentInfo":661,"targetDuration":4,"studyType":57,"phases":663,"briefSummary":664,"conditions":665,"keywords":671,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":680,"locationsCount":348},"100480983","cognitive-behavioral-therapy-and-exercise-training-in-adolescents-at-risk-for-type-2-diabetes-100480983","NCT05543083","Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes","CBTeX","Inclusion Criteria:\n\n* Female\n* Age 12-17 years\n* Body Mass Index (BMI)\\>= 85 for age and sex\n* Type 2 Diabetes (T2D) first-or second-degree relative\n* Center for Epidemiologic Studies Depression Scale (CES-D) total score \\>=21\n\nExclusion Criteria:\n\n* T2D\u002F Type 1 Diabetes (T1D) or any major medical condition (e.g. cardiovascular, renal) that would prohibit the ability to participate in exercise training\n* Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) conduct disorder, substance abuse\u002F dependence, obsessive compulsive disorder, panic attacks, post-traumatic stress disorder, anorexia\u002Fbulimia, \\& schizophrenia\n* Insulin sensitizers, weight loss medications \\& chronic steroids\n* Structured weight loss treatment or bariatric surgery\n* Pregnancy, nursing","12 Years","17 Years",{"count":662,"type":23},300,[216],"The investigators are doing this study to learn more about how to prevent type 2 diabetes in teenage girls. The purpose of this study is to find out if taking part in a cognitive-behavioral therapy group, exercise training group, or a combination of cognitive-behavioral therapy and exercise training groups, decreases stress, improves mood, increases physical activity and physical fitness, and decreases insulin resistance among teenagers at risk for diabetes.",[382,666,667,668,669,670,247,29],"Depression","Depressive Disorder","Mood Disorders","Mental Disorder in Adolescence","Hyperinsulinism",[672,673],"Adolescent Type 2 Diabetes Prevention","Exercise Training","2026-04-17",{"date":676,"type":37},"2026-04-22",{"date":678,"type":37},"2023-06-02",{"date":538,"type":23},{"name":681,"class":229},"Colorado State University",{"id":683,"slug":684,"hasResults":12,"nctId":685,"briefTitle":686,"officialTitle":686,"acronym":687,"eligibilityCriteria":688,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":568,"enrollmentInfo":689,"targetDuration":4,"studyType":57,"phases":691,"briefSummary":692,"conditions":693,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":694,"lastUpdatePostDateStruct":695,"startDateStruct":697,"completionDateStruct":699,"leadSponsor":701,"locationsCount":45},"100501249","metabolic-adaptations-to-weight-loss-with-and-without-exercise-100501249","NCT05806801","Metabolic Adaptations to Weight Loss With and Without Exercise","WAX","Inclusion criteria\n\n* Age: 18-40\n* Body Mass Index: 30-40 kg\u002Fm2\n* Weight stable (±3kg for greater than or equal to about 2 months)\n* No regularly planned exercise\u002Fphysical activity\n* Women must have regularly occurring menses and must be premenopausal\n\nExclusion criteria\n\n* EKG abnormalities\n* Evidence\u002Fhistory of cardiovascular disease, diabetes or other metabolic disease\n* Medications known to affect lipid or glucose metabolism\n* Pregnant or lactating\n* Tobacco or e-cigarette use\n* Prior experience of hypersensitivity to insulin, human albumin, and potassium chloride injection.\n* Allergies\u002Fhypersensitivity to local anesthetics of the amide type (e.g., lidocaine)\n* History of hyperkalemia or potential for developing hyperkalemia (including but not limited to taking drugs that may induce hyperkalemia such as cardiac glycosides or potassium sparing diuretics)\n* Anti-coagulant medication (e.g., Coumadin, Rivaroxaban) and Lidocaine allergy\u002Fsensitivity are exclusion criteria for the biopsy procedure.",{"count":690,"type":23},68,[216],"Study Purpose:\n\nThe combination of caloric restriction and exercise is the most common first-line treatment for obesity-related disorders, yet we know very little about how these two very different treatments work together. A deeper understanding about mechanisms underlying the health benefits of adding exercise to a weight loss program will not only aid efforts to optimize more effective lifestyle interventions, but it can also uncover novel targets for the treatment\u002Fprevention of obesity-related diseases.\n\nAlthough a reduction in body fat is the fundamental adaptation to weight loss, we know almost nothing about the effects that adding exercise has on structural and functional changes within fat tissue that may further enhance metabolic health. This is very important because many obesity-related metabolic health complications are tightly linked with abnormalities in abdominal fat tissue. We argue exercise-induced modifications in abdominal fat tissue will reveal persistent health benefits even if some weight is regained\n\nStudy Summary:\n\n10% Weight Loss Phase - Subject participation in the study will involve a series of metabolic tests before, at midpoint, and after undergoing a 10% weight loss program (with or without exercise training depending on group randomization). During this, subjects will be randomized into one of two different experimental groups:\n\n1. Moderate Intensity Continuous Training (MICT) exercise group\n2. No exercise (control) group\n\nFollow-up Phase: After completing the metabolic testing post-weight loss, all study-related diet and exercise supervision will end and subjects will be free to make their own choices regarding diet and exercise\u002Fphysical activity behavior. Subjects will then be asked to complete follow-up testing at 2-, 4- and 6- months post-weight loss.\n\nTotal involvement in the study for each subject will likely be about 10-13 months (4-7 months during weight loss phase, 6 months during follow-up phase).",[156,29,597,281,382,485],"2026-04-10",{"date":696,"type":37},"2026-04-14",{"date":698,"type":37},"2023-07-19",{"date":700,"type":23},"2028-05-31",{"name":392,"class":229},{"id":703,"slug":704,"hasResults":12,"nctId":705,"briefTitle":706,"officialTitle":706,"acronym":4,"eligibilityCriteria":707,"healthyVolunteers":17,"sex":18,"minAge":708,"maxAge":4,"enrollmentInfo":709,"targetDuration":4,"studyType":57,"phases":711,"briefSummary":712,"conditions":713,"keywords":716,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":694,"lastUpdatePostDateStruct":718,"startDateStruct":720,"completionDateStruct":722,"leadSponsor":724,"locationsCount":45},"100478922","insomnia-treatment-and-cardiometabolic-health-in-older-adults-with-posttraumatic-stress-disorder-100478922","NCT05516277","Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder","Inclusion Criteria:\n\n* Community-dwelling Veterans aged 50 years and older\n* Received care from a Veterans Health Administration (VHA) facility in the prior year\n* Diagnosis of PTSD\n* Diagnosis of insomnia disorder\n* Lives within a 50-mile radius of the research offices at the VA Sepulveda Ambulatory Care Center\n\nExclusion Criteria:\n\n* Active substance use or in recovery with less than 90 days of sobriety\n* Too ill to engage in the study procedures (e.g., unable to attend the in-person meetings)\n* Unable to self-consent to participate\n* Unstable housing (as this will impact the research team's ability to retrieve costly and difficult to replace monitoring equipment)\n* Severe cardiovascular or respiratory disease (e.g., ventilatory failure, CHF)\n* Unstable medical or psychiatric disorders (which are a contraindication for behavioral treatment of insomnia)\n* Comorbid sleep disorders (i.e., central sleep apnea syndrome, diagnosed narcolepsy or circadian rhythm sleep-wake phase disorders) based on medical record review and baseline assessment data, or untreated, severe sleep disordered breathing (SDB) as assessed via WatchPAT or previous clinical evaluation (apnea-hypopnea index \\[AHI\\] ≥ 30; or AHI ≥ 15 plus Epworth Sleepiness Scale \\[ESS\\] score ≥ 10) that better explain sleep difficulties","50 Years",{"count":710,"type":23},167,[216],"This pilot pre-post trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. This study provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by a non-medication sleep education and treatment program (Cognitive Behavioral Therapy for Insomnia, CBT-I) for sleep problems that remain after completing PTSD treatment in older adults with PTSD. The aims of this project are to evaluate 1) the added benefits of treating residual insomnia on sleep and PTSD symptoms; 2) the added benefits of treating residual insomnia following CPT on cardiometabolic risk biomarkers and quality of life; and 3) the durability of the sleep, PTSD, cardiometabolic and quality of life benefits of treating residual insomnia following CPT at 6-month follow-up in older adults with PTSD.",[714,715,274,29],"Posttraumatic Stress Disorder","Insomnia",[717],"Quality of Life",{"date":719,"type":37},"2026-04-15",{"date":721,"type":37},"2023-04-01",{"date":723,"type":23},"2028-03-31",{"name":725,"class":229},"University of California, Los Angeles"]