[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetes":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,254,0,25,[9,45,77,103,133,162,188,214,249,270,293,312,333,361,390,413,434,455,475,495,520,556,586,618,642],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100622816","evaluation-of-the-clinical-spectrum-of-diabetes-and-obesity-in-youth-and-adults-100622816",false,"NCT07388537","Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age 8 years to 65 years\n2. Meet at least one of the following:\n\n   a. Overweight\u002FObesity:\n\n   i. For participants under 18 years of age: BMI \\>= 85th percentile for age and sex\n\nii. For participants \\>= 18 years of age: BMI \\>= 25 kg\u002Fm\\^2 (\\>=23 kg\u002Fm\\^2 for self-reported Asian race\u002Fethnicity)\n\nb. Suspected or evidence of hyperglycemia:\n\ni. Diagnosis of prediabetes or diabetes in medical history or by participant\u002Fguardian\u002FLegally Authorized Representative (LAR) report, OR\n\nii. Fasting blood glucose \\>= 100 mg\u002FdL in medical record, OR\n\niii. Postprandial blood sugar \\>= 140 mg\u002FdL in medical record, OR\n\niv. Hemoglobin A1c \\>= 5.7% in medical record\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History of significant medical illnesses that the investigators feel may interfere with potential evaluations, i.e. individuals who are critically ill, unstable, or with severe organ failure that may affect\u002Flimit the endocrine evaluation and place unsustainable demands on Clinical Center or NIDDK resources.\n2. History of any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the participant.\n3. Inability or unwillingness of participant, parent\u002Fguardian, or LAR to provide informed consent.","ALL","8 Years","65 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","Background:\n\nDiabetes and obesity are chronic diseases. They can affect blood flow and how the body processes nutrients, and complications over time can lead to early death. Diabetes can affect children as well as adults, but the disease seems to be more severe and to progress faster when it appears in younger people. Researchers want to understand more about how diabetes and obesity develop and change over time.\n\nObjective:\n\nTo collect data and samples regularly from people with obesity and diabetes.\n\nEligibility:\n\nPeople aged 8 to 65 years. They must be overweight or obese; or have high blood sugar; or have problems with how their body uses food for energy.\n\nDesign:\n\nParticipants will have additional procedures during routine care visits at the NIH clinic.\n\nData collected for the study will include the following:\n\nInformation from the participant s medical chart will be kept for research.\n\nQuestionnaires will ask about participant s eating habits, feelings, sleep, and substance use. They will take 30 to 60 minutes. Care providers will address any issues revealed in these surveys.\n\nBlood, saliva, urine, and stool samples will be collected. Samples may be used for genetic tests.\n\nData and samples will be kept for future research.\n\nParticipants may remain in the study up to 30 years.",[25,26,27],"Obesity","Diabetes","Metabolic Disorders",[29,25,30,31],"Clinical Spectrum of Diabetes","Hyperglycemia","Metabolic Disease","NOT_YET_RECRUITING","2026-08-20",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":21},"2026-08-26",{"date":40,"type":21},"2055-04-30",{"name":42,"class":43},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":74,"leadSponsor":76,"locationsCount":44},"100617066","effects-of-meal-macronutrients-on-postprandial-lipids-100617066","NCT07313787","Effects of Meal Macronutrients on Postprandial Lipids","Prospective Cross-Over Study of the Effects of Meal Macronutrients on Postprandial Lipids","* INCLUSION CRITERIA:\n\nCommon inclusion criteria (all groups):\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age \\>= 18 years\n2. Average alcohol intake in the past 6 months \\\u003C 3 drinks (approximately 30g) per day (male) or \\\u003C 2 drinks (approximately 20 g) per day (female)\n\nHealthy control specific inclusion criteria:\n\n1. In good general health with no known active medical conditions as evidenced by medical history\n2. Fasting glucose \\\u003C100 mg\u002FdL\n3. HbA1c \\\u003C5.7%\n4. Fasting triglycerides \\\u003C150 mg\u002FdL\n5. ALT and AST within normal limits\n6. BMI \\>=18.5 to \\\u003C25 kg\u002Fm\\^2 (or \\\u003C23 kg\u002Fm\\^2 in participants of Asian descent)\n7. Not taking any medications or supplements that, in the opinion of the investigator, would interfere with interpretation of study data.\n\nMetabolic syndrome specific inclusion criteria\n\n1. Obesity defined as either\n\n   1. BMI \\>30 kg\u002Fm\\^2 (or \\>=27 kg\u002Fm\\^2 in participants of Asian descent), OR\n   2. Elevated waist circumference as defined below:\n\n      * Country\u002FEthnic group - Europid, Sub-Saharan African, Eastern Mediterranean and Middle East (Arab):\n\n        * Sex: Male; Waist circumference: \\>=94cm\n        * Sex: Female; Waist circumference: \\>=80cm\n      * Country\u002FEthnic group - South Asian, Chinese, Japanese, Ethnic South and Central American:\n\n        * Sex: Male; Waist circumference: \\>=90cm\n        * Sex: Female; Waist circumference: \\>=80cm\n\n   Plus any 2 of the following\n2. Elevated triglycerides defined as EITHER\n\n   1. Fasting triglycerides \\>= 150 mg\u002FdL at screening, OR\n   2. Specific treatment for hypertriglyceridemia\n3. Low HDL cholesterol, defined as EITHER\n\n   1. HDL \\\u003C40 mg\u002FdL (males) or \\\u003C50 mg\u002FdL (females) at screening, OR\n   2. Specific treatment for low HDL\n4. Elevated blood pressure defined as EITHER\n\n   1. Systolic BP \\>= 130 at screening, OR\n   2. Diastolic BP \\>= 85 mm Hg at screening, OR\n   3. Treatment of previously diagnosed hypertension\n5. Elevated glucose defined as EITHER\n\n   1. HbA1c \\>= 5.7% (at screening), OR\n   2. Fasting serum glucose \\>= 100 mg\u002FdL (at screening), OR\n   3. 2-hour post-load glucose levels \\>= 140 mg\u002FdL (by history), OR\n   4. Prior diagnosis of type 2 diabetes\n\nLipodystrophy-specific inclusion criteria:\n\n1. Clinical diagnosis of generalized or partial lipodystrophy based on reduction in adipose tissue outside the normal range in some or all adipose depots (including, at a minimum, the gluteofemoral depot).\n2. Insulin resistance as defined by fasting insulin \\>22.5 or high exogenous insulin requirement (\\> 2 units per kg per day or \\> 200 units total per day) at screening.\n\nNephrotic syndrome specific inclusion criteria\n\n1. History of biopsy proven non-diabetic glomerular disease (any histology)\n2. Nephrotic range proteinuria defined by ANY of the following:\n\n   1. Protein\u002Fcreatinine ratio uPCR \\>= 3.5 g\u002Fg at screening, OR\n   2. 24 hour protein excretion \\>= 3.5 gr\u002F24hr) at screening, OR\n   3. History of nephrotic range proteinuria (as defined above) within the past 5 years but in complete (defined as proteinuria \\\u003C= 0.3 g\u002Fday or partial remission (defined as a 50% or greater decrease in proteinuria compared to baseline and proteinuria \\\u003C 3.5 g\u002Fday) based on 24 hr urine or uPCR at time of screening\n\nEXCLUSION CRITERIA:\n\nCommon exclusion criteria (all groups):\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Consuming extreme macronutrient diet (e.g., very low-carbohydrate, high fat diets such as ketogenic, \"paleo\" or Atkins diets, among others).\n2. Plans to actively gain or lose weight during the study period (other than changes in water balance as clinically needed in subjects with nephrotic syndrome).\n3. Change in body weight of \\>5% or \\>3 kg (whichever is larger) in the 3 months prior to screening (by participant report) in participants who do NOT have nephrotic syndrome.\n4. Body weight \\>450 lbs (upper limit that can be accommodated by DXA scanner).\n5. Participating in a regular strenuous exercise program (\\> 2h\u002Fweek of vigorous activity) as determined by volunteer report or evidence of vigorous exercising in order to lose weight, change body shape, or to counteract the effects of eating.\n6. Uncontrolled diabetes, defined as HbA1c \\>9% at screening.\n7. Lipemia defined as fasting or non-fasting triglycerides of \\>1000 mg\u002FdL at screening.\n8. Renal dysfunction defined as eGFR \\\u003C50 mL\u002Fmin\u002F1.73 m\\^2 at screening.\n9. In participants with liver disease, history of decompensated advanced liver disease, defined as direct bilirubin \\> 0.5 g\u002FdL, PT \\> 18 seconds, albumin \\\u003C 3 g\u002FdL, MELD score \\> 12, or history of ascites, encephalopathy, variceal bleeding, spontaneous bacterial\n\n   peritonitis or liver transplant.\n10. History of hypertriglyceridemia-induced pancreatitis within 3 months prior to screening.\n11. Positive pregnancy test or breastfeeding at screening.\n12. Clinically significant abnormalities in thyroid function, blood counts, as assessed by screening labs.\n13. Acute cardiovascular events within the past 6 months\n14. Anemia (Hgb \\\u003C10 mg\u002FdL in women or \\\u003C12 mg\u002FdL in men) at screening\n15. Food allergies or other dietary restrictions that could increase risk associated with test meals or cause the subject to be unwilling to consume test meals (i.e. celiac disease, vegan diets).\n16. Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.\n17. Subjects treated with tamoxifen, estrogens, or progestins that have not been stable for \\>4 weeks prior to screening.\n18. Blood donation in the last 2 weeks or planned blood donation during the study\n19. Subjects requiring regular transfusions for any reason.\n20. Subjects with known gastroparesis\n21. Inability to adhere to Lifestyle Considerations throughout study duration.\n22. Inability of the subject to understand and the unwillingness to sign a written informed consent document.\n23. Unwillingness to comply with all study procedures and unavailable for the duration of the study\n24. Any other condition or medication which, in the opinion of the investigator, increases risk to the subject, prevents the subject from complying with study procedures, prevents the subject from completing the study, or interferes with the interpretation of study results.","18 Years","120 Years",{"count":55,"type":21},100,"INTERVENTIONAL",[58],"PHASE2","Background:\n\nAbnormal fats in the blood can lead to many problems, including heart disease. Researchers want to learn more about how eating meals with different levels of nutrients affects fats in the blood. Specifically, they want to study people with too much body fat, too little body fat, and a kidney problem called nephrotic syndrome.\n\nObjective:\n\nTo learn more about how different types of foods affect fat levels in the blood.\n\nEligibility:\n\nPeople aged 18 years or older with a health condition that affects how their body handles fats. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 2 overnight stays in the clinic within 6 months. At each visit, after staying overnight, they will eat a breakfast casserole. At 1 visit, breakfast will be a high-fat, low carbohydrate meal. At the other, it will be a high-carbohydrate, low-fat meal.\n\nParticipants will have a tube inserted into a vein in their arm. They will have blood drawn via the tube 12 times in 8 hours: 2 times before they eat the breakfast and 10 times after.\n\nParticipants will have other tests during their stays:\n\n* A resting metabolic test captures the air they exhale and measures how much energy they use at rest.\n* A dual energy X-ray absorptiometry (DXA) scan measures how much fat and muscle they have.\n* A Fibroscan is a special type of ultrasound of the liver.\n* A body surface scan uses lasers to measure the total area of the body.\n* A bioelectric impedance (BIS) exam measures how fast small electric currents move through their body.\n\nParticipants may opt to have a third visit. At this visit, the breakfast will be high in protein....",[61,62,63,64,26,65],"Nephrotic Syndrome","Lipodystrophy","Metabolic Syndrome","Healthy Volunteer","Metabolic Associated Steatotic Liver Disease",[67,68,69,70,71],"postprandial lipids","macronutrient","CARBOHYDRATES","FATS","Proteins",{"date":35,"type":36},{"date":38,"type":21},{"date":75,"type":21},"2031-08-01",{"name":42,"class":43},{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":56,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":44},"100646024","pns-to-improve-vascular-function-and-limb-health-in-veterans-100646024","NCT07696988","PNS to Improve Vascular Function and Limb Health in Veterans","Peripheral Neural Stimulation to Improve Microvascular Function and Limb Health in Veterans With Diabetic Peripheral Neuropathy","Inclusion Criteria:\n\nInclusion Criteria - All Participants:\n\n* English-speaking\n* Veteran\n\nInclusion Criteria - Diabetic Peripheral Neuropathy (DPN) Participants:\n\n* Confirmed diagnosis of type 1 or type 2 diabetes mellitus for at least 5 years\n* Clinical signs and\u002For symptoms consistent with diabetic peripheral neuropathy Or confirmation of neuropathy via physical exam\n\nInclusion Criteria - Lower Limb Amputees:\n\n* Unilateral transtibial or transfemoral amputation\n* Medically stable for at least 3 months\n* For the designated subset of the limb-loss cohort (n = 6): implanted with C-FINEs on the sciatic and\u002For tibial nerves\n\nExclusion Criteria:\n\nExclusion Criteria - All Participants:\n\n* Severe neurological disorders impairing ambulation\n* Visual or hearing impairments interfering with study participation\n* Cardiovascular or respiratory conditions posing risk during participation\n* Cognitive or psychiatric conditions compromising informed consent\n* Participation in other clinical trials interfering with outcomes\n* Pregnancy\n* History of photosensitivity or known sensitivity to laser light\n\nAdditional Exclusion Criteria - Amputees:\n\n* Active skin breakdown or infection at residual limb\n* Significant phantom or residual limb pain interfering with study procedures\n* Bilateral lower-limb amputation",true,{"count":86,"type":21},42,[88],"NA","Establishing a sensitive, scalable physiological test for neurovascular reflex integrity and investigating whether targeted peripheral neural stimulation can enhance perfusion and vasodilatory responsiveness.",[91,26],"Lower Limb Amputees",[93,26],"lower extremity limb loss","2026-08-19",{"date":35,"type":36},{"date":97,"type":21},"2026-11-02",{"date":99,"type":21},"2030-05-30",{"name":101,"class":102},"VA Office of Research and Development","FED",{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":56,"phases":113,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":44},"100488671","enhancing-shared-decision-making-to-guide-care-for-people-with-dementia-and-diabetes-100488671","NCT05643144","Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes","Enhancing Shared Decision-making to Prompt and Guide Individualized Care for People With Alzheimer's Disease and Diabetes","CGM ASSIST","Patient-Caregiver Dyad Inclusion Criteria:\n\n* patient must have dual diagnosis of MCI or ADRD and diabetes (DM)\n* patient must have active prescriptions for DM\n* patient must have had at least one visit to an Eskenazi or IU Health primary care clinic within 12 months\n* patient must be able to provide assent and have a legally authorized representative (LAR) consent on their behalf if patient lacks capacity to consent\n* patient must have a caregiver aged 18 years or older who interacts daily, or almost daily, with the patient\n* patient and caregiver must both speak English\n* patient and caregiver must both reside in the community\n* dyad must have internet access\n\nPatient-Caregiver Dyad Exclusion Criteria:\n\n* patient has terminal illness\n* use of an automated insulin delivery system\n* patient is receiving dialysis\n* patient is taking ascorbic acid during monitoring period\n* patient has existing implanted medical devices\n* patient has a bleeding disorder\n* patient has a pre-existing arm skin lesions\n* patient has an allergy to medical adhesive or isopropyl alcohol\n* patient has plans for imaging or diathermy treatment during the study period",{"count":112,"type":21},62,[88],"The goal of this study is to test CGM ASSIST. This is a digital tool that uses an interactive information display-an easy-to-read screen designed to help people with dementia (or memory loss) and diabetes, as well as their caregivers and doctors.\n\nManaging diabetes is often difficult for people with memory issues. This study uses a Continuous Glucose Monitor (CGM), which is a device that tracks blood sugar levels in real-time. CGM ASSIST adds a new way to see this data through interactive displays. These displays show clear information and medical guidelines to help patients and caregivers make sense of the glucose readings.\n\nThe study aims to:\n\n* Increase Awareness: Help patients and caregivers recognize the dangers of low blood sugar (hypoglycemia) and how to treat it.\n* Improve Teamwork: Encourage \"shared decision-making,\" where patients, caregivers, and doctors work together to make health choices.\n* Test Feasibility: See if it is easy and helpful for people with memory loss to use these interactive displays in their daily lives.\n* Understand Experiences: Learn how the thoughts and feelings of patients and families affect how they manage diabetes.\n\nBy using these interactive displays, the researchers hope to make it easier for families to understand their health needs and communicate better with their medical team.\n\nParticipants will:\n\n* Answer a survey about how they manage their diabetes\n* Learn how to use a Continuous Glucose Monitor and wear it for 14 days\n* Answer 3 brief telephone surveys during these 14 days\n* Complete a clinic visit with their doctor and answer a final survey on how this visit went using the CGM ASSIST report",[26,116,117,118],"Alzheimer's Disease (Incl Subtypes)","Dementia","Hypoglycemia",[120,121,122,123],"Continuous glucose monitoring","Shared decision-making","Human factors","Primary care","RECRUITING",{"date":33,"type":36},{"date":127,"type":21},"2026-09-07",{"date":129,"type":21},"2027-06-30",{"name":131,"class":132},"Indiana University","OTHER",{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":84,"sex":16,"minAge":52,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":143,"conditions":144,"keywords":149,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":44},"100439876","caregiving-networks-across-disease-context-and-the-life-course-100439876","NCT05007990","Caregiving Networks Across Disease Context and the Life Course","Caregiving Networks Across Disease Context and the Life Course: A Comparative Longitudinal Study","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Adults aged 18 years and older\n* If the Care Recipient is living, they must self-identify as a primary caregiver to the Care Recipient (individual with a chronic medical condition), OR if the Care Recipient is deceased, they must self-identify as having been a primary caregiver to the now-deceased Care Recipient, OR they must otherwise be identified (i.e., referred) by a participant as a part of the caregiving network\n* Ability to consent to research\n* Fluency in English will be needed to complete interview as well as to read, comprehend surveys and consent forms, as appropriate validated measures in other languages are not readily available.\n* Physically capable of participating in applicable assessments\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from this study:\n\n* Care Recipients (as defined in this protocol)\n* Staff of NHGRI\n\nStaff of NHGRI are unable to participate in this study as a safeguard against the risk of ethical concerns. As per OHSRP SOP 404, NIH staff may be a vulnerable class of study subjects. Excluding staff of the Institute conducting the study assures there will not be any perceived or actual conflict of interest, pressure\u002Fcoercion to participate among co-workers, subordinates, work unit-members, etc. As further noted in OHSRP SOP 404, exclusion further protects this class of subjects privacy and confidentiality; and protects the study s scientific integrity.\n\nPersons with impaired neuro-sensory or decision-making ability (adults unable to provide consent) will not be enrolled in the study. Persons with impaired neuro-sensory or decision making ability would not be able to participate with independent responses to the various social behavioral measures we use in the study interview and survey. Learning information about these individuals through other people instead of themselves would introduce bias to this study.","100 Years",{"count":142,"type":21},2800,"Background:\n\nIn the U.S., about 53 million informal, unpaid caregivers provide care to a person who is ill, is disabled, or has age-related loss of function. These caregivers may be adult children, spouses, parents, or others. The stress of providing long-term care affects caregivers health and well-being. Researchers want to learn more about this stress and its effects.\n\nObjective:\n\nTo learn how the caregiving process affects the health and well-being of caregivers over time.\n\nEligibility:\n\nAdults aged 18 years and older who are caregivers for a person with a chronic medical condition and who have already given consent to take part in other study activities.\n\nDesign:\n\nParticipants will be put in different groups. They will complete some or all of the following tasks over 1 year. They may repeat these tasks once a year for up to 5 years.\n\nParticipants will fill out 2 online surveys. One will ask about their health and their caregiving experience. The other will ask them to list people in their social network and their care recipient s social network who give them support.\n\nParticipants will have a 2-part phone interview. It will be audio recorded. In part 1, they will be asked about the people they listed in the survey. In part 2, they will be asked about their caregiving experience and events in the care recipient s life.\n\nParticipants may fill out a weeklong diary every 3 months. It will ask about their daily social activities, well-being, and stress levels. It will also ask about their thoughts and feelings about caregiving.\n\nParticipants may give a blood sample each year they are in the study.\n\n...",[145,146,147,148,26],"Inherited Metabolic Disorders","Undiagnosed Diseases","Batten's Disease","Tay Sachs",[150,151,152,153,154],"Social Support","Rare Diseases","Natural History","Genetic Conditions","Family Network",{"date":33,"type":36},{"date":157,"type":36},"2022-09-08",{"date":159,"type":21},"2030-12-31",{"name":161,"class":43},"National Human Genome Research Institute (NHGRI)",{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":84,"sex":16,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":172,"conditions":173,"keywords":177,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":44},"100469897","a-natural-history-study-of-metabolic-sizing-in-health-and-disease-100469897","NCT05398783","A Natural History Study of Metabolic Sizing in Health and Disease","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all the following criteria for their cohort:\n\nCohort 1 - Healthy Volunteers\n\n* Male or female, aged \\>=2 years\n* In good general health as evidenced by medical history\n\nCohort 2 - Patients\n\n* Male or female, aged \\>=2 years\n* Diagnosed with diseases thought to alter metabolism or body composition (such as weight loss or gain, diabetes, renal disease, obesity, cancer, etc.) or taking medications thought to alter metabolism or body composition.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Participants over 200 kg due to the weight limit of the equipment.\n* Presence of any implanted device that would interfere with measurements.\n* Any moderate to severe limitations in mobility that would impede participation\n* Hemoglobin less than 10 g\u002FdL (in participants who would have blood drawn for research purposes).\n* Participants with dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.\n* Participants unwilling or unable to give informed consent.\n* Participants with any other significant physical, medical, or psychiatric limitations, illness or conditions that may preclude them from completing the majority of the tests in this study per the discretion of the PI.","2 Years","99 Years",{"count":171,"type":21},2000,"Background:\n\nScientists have long used simple measures (such as height and weight) to estimate how much a person s body uses food (calories) as energy, as commonly called the metabolic rate. But metabolism varies among people with similar body sizes. Scientists now believe the old formulas for estimating metabolic rates may not work well for all people. Researchers want to find more accurate ways to measure a person s metabolism.\n\nObjective:\n\nThis natural history study will examine the relationships between metabolism, body composition, and body surface area in a wide range of people.\n\nEligibility:\n\nHealthy children and adults aged 2 years or older. Also, people aged 2 years or older with conditions that may alter metabolism. These may include diabetes, obesity, renal disease, or cancer.\n\nDesign:\n\nParticipants will spend 2 days and 1 night in the hospital. They will provide a medical history and answer questions about their activity levels, the foods they eat, and their lifestyle. They will also eat a special diet.\n\nParticipants will undergo many tests:\n\nThey will lie in a bed with a clear hood covering their head for 30 to 45 minutes to measure the gases in their breath.\n\nThey will lie on a padded table for about 15 minutes while their body is scanned.\n\nThey will stand on a platform while a 3D scanner measures their body.\n\nThey will have a test to measure how fast an electric signal moves through their body.\n\nThey will grip an instrument to measure the strength of their hands.\n\nThey will drink salty water and provide blood and urine samples.\n\nParticipants may be invited to return for these 2-day visits up to 8 times per year. Return visits must be at least 2 weeks apart.",[27,174,175,26,176],"Cancer","Chronic Kidney Disease","Normal Physiology",[178,179,180,152],"Body Composition","Metabolism","Body Surface Area","2026-08-18",{"date":94,"type":36},{"date":184,"type":36},"2022-10-25",{"date":186,"type":21},"2031-07-01",{"name":42,"class":43},{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":84,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":56,"phases":197,"briefSummary":198,"conditions":199,"keywords":203,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":4},"100652155","negative-pressure-wound-therapy-devices-in-total-knee-arthroplasty-100652155","NCT07770633","Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty","Randomized Controlled Clinical Trial for Closed Incision Negative Pressure Wound Therapy (NPWT) Devices in Total Knee Arthroplasty (TKA)","Inclusion Criteria:\n\n* Age 18 years or older\n* Undergoing primary total knee arthroplasty\n* Able to understand the study, provide informed consent, and participate in study procedures\n\nMeet at least one of the following co-morbidities:\n\n* BMI ≥35\n* Diabetes\n* Prior surgical incision(s) in the operative area\n* Chronic kidney disease\n\nExclusion Criteria:\n\n* Prisoners\n* Pregnant women\n* Patients who indicate they may not comply with post-operative instructions\n* Patients with active bleeding",{"count":196,"type":21},300,[88],"This study is a single-center, prospective, randomized, open-label clinical trial evaluating three commercially available closed-incision negative pressure wound therapy (ciNPWT) devices: NPseal, PICO, and Prevena, in adult patients undergoing primary total knee arthroplasty (TKA) who meet predefined high-risk criteria for wound complications.\n\nA total of approximately 300 participants will be enrolled and randomized in a 1:1:1 fashion to receive one of the three study dressings applied over the closed surgical incision at the end of the procedure. All participants will otherwise receive standard perioperative and postoperative care. The primary follow-up period will extend through 90 days after surgery.\n\nThe primary objective is to compare the incidence of 90-day surgical site complications, including superficial infection, wound dehiscence, seroma, and hematoma, across the three dressing groups. Secondary objectives include evaluation of device usability, patient experience, and device-related issues (such as loss of seal, alarms, tubing or pump problems, fluid saturation, and premature dressing changes), as well as assessment of the interaction between skin closure method and device performance.\n\nResearch-specific activities are limited to eligibility confirmation, informed consent, randomization, administration of a brief postoperative patient survey at approximately postoperative day 7 and\u002For dressing removal, provider assessment of the dressing at removal, and collection of clinical outcomes from the medical record. No additional blood draws, imaging, or invasive procedures are required for participation.\n\nThis study is designed to address a gap in the literature by providing head-to-head comparative data on commonly used ciNPWT systems in a high-risk primary TKA population, with the goal of informing postoperative wound management strategies in clinical practice.",[200,26,25,201,202],"Wound Surgical","Chronic Kidney Diseases","Smoking",[204,205],"Total Knee Arthroplasty","Total Knee Replacement","2026-08-17",{"date":181,"type":36},{"date":209,"type":21},"2026-09-01",{"date":211,"type":21},"2030-12",{"name":213,"class":132},"The Cleveland Clinic",{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":16,"minAge":222,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":56,"phases":226,"briefSummary":227,"conditions":228,"keywords":234,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":4},"100652068","a-prospective-multicenter-study-evaluating-the-metabolic-effects-of-pulsendo-therapy-in-adults-with-type-2-diabetes-100652068","NCT07768631","Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes","A Prospective, Multicenter, Randomized, Sham-Controlled Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes (pULSENDO Study)","pulsENDO","Inclusion Criteria:\n\n1. 22- 75 years of age, inclusive.\n2. T2D diagnosis for at least 6 months.\n3. HbA1c of 7.5-10.5%, inclusive, for participants on 1-3 GLMs or or if on 4 glucose-lowering medications must have HbA1c between 7.5% - 9.0%, inclusive.\n4. BMI 27-40 kg\u002Fm2, inclusive.\n5. On 1-4 non-insulin glucose lowering medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit\n6. If on lipid-lowering medications, the medication stable for at least 12 weeks .\n7. Individualized metabolic surgery (IMS) score ≤ 115.\n8. Weight stability (≤5% weight change) for at least 12 weeks\n9. Agree not to donate blood during participation in the study.\n10. Women of childbearing potential must not be pregnant and using an acceptable method of contraception throughout the study.\n11. Willing and able to comply with study visits and study requirements.\n12. Understand and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosed with type 1 diabetes.\n2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.\n3. Fasting serum C-peptide \\\u003C1 ng\u002FmL (333pmol\u002Fl).\n4. Current use of insulin, or previous use of any types of insulin for \\>1 month at any time (except for treatment of gestational diabetes) in last 2 years.\n5. Hypoglycemic unawareness.\n6. History of ≥1 severe hypoglycemia episode in past 6 months\n7. Discontinuation of a GLP-1 or a GLP-1\u002FGIP dual-agonist within 6 months of the screening visit following at least one month of treatment.\n8. Known autoimmune disease\n9. Previous GI surgery that has changed GI anatomy\n10. Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure\n11. History of gastroparesis.\n12. Acute gastrointestinal illness in the last 7 days.\n13. Known history of inflammatory disease (e.g. Crohn's disease, ulcerative colitis, inflammatory bowel disease), radiation enteritis or other chronic inflammatory disorders of the bowel.\n14. History of chronic or acute pancreatitis.\n15. Active hepatitis or active liver disease, or alanine aminotransferase (ALT) level \\>3.0 times the upper limit of normal (ULN)\n16. Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) from treatment through 4 weeks following the procedure.\n17. Use of systemic glucocorticoids for more than 10 consecutive days within 12 weeks\n18. Use of medications known to affect GI motility (e.g. metoclopramide\u002F Reglan)\n19. Current use of weight loss medications or other weight loss medications including over-the-counter \\[OTC\\] medications or have discontinued weight loss medications within 6 months.\n20. Participation in any structured weight loss program or endoscopic weight loss intervention within 6 months.\n21. Persistent anemia, defined as hemoglobin \\\u003C10 g\u002FdL.\n22. Known history of hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.\n23. History of blood donation or transfusion within 3 months.\n24. Unstable or paroxysmal cardiac arrhythmia.\n25. Any of the following cardiovascular conditions within 6-months prior to screening visit: acute myocardial infarction, unstable angina, cerebrovascular accident (stroke), hospitalization due to congestive heart failure, or history of other significant cardiovascular disease\n26. Heart failure\u002Fvalvular disease: NYHA Class III or IV heart failure, or clinically significant valvular heart disease associated with symptoms or increased procedural\u002Fanesthesia risk\n27. Estimated glomerular filtration rate (eGFR) ≤ 45 ml\u002Fmin\u002F1.73m2\n28. Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.\n29. History of secondary hypothyroidism or inadequately controlled primary hypothyroidism\n30. Presence of any implanted electronic devices that cannot be turned off during the procedure\n31. Presence of duodenal or biliary stents.\n32. Not a candidate for upper GI endoscopy or general anesthesia.\n33. Active illicit substance abuse or alcoholism (\\>2 drinks\u002Fday regularly).\n34. Active malignancy within the last 5 years (excluding non-melanoma skin cancers).\n35. Women who are breastfeeding.\n36. Participating in another ongoing clinical trial of an investigational drug or device.\n37. Current or history within the past 12 months of binge eating disorder, bulimia nervosa, anorexia nervosa, or night eating syndrome.\n38. Clinically significant psychiatric illness, defined as any of the following: (a) psychiatric hospitalization within the past 24 months; (b) a history of suicide attempt, or active suicidal ideation within the past 24 months; or (c) a diagnosis of schizophrenia, other psychotic disorder, or bipolar disorder that is not clinically stable on current management\n39. Critically ill or has a life expectancy \\\u003C5 years.\n40. Are investigator site personnel directly affiliated with this study and\u002For their immediate family member. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.\n\n    Additional exclusion criteria to be evaluated during the screening process:\n41. HbA1c \\\u003C 7.5% or \\> 10.5% at baseline visit.\n42. Uncontrolled hyperglycemia with a glucose level \\>270 mg\u002Fdl (\\>15 mmol\u002FL) after an overnight fast or \\>360 mg\u002Fdl (\\>20 mmol\u002Fl) in a randomly performed measurement that is confirmed by a second measurement (not on the same day) between screening and baseline visit.\n43. Active systemic infection, febrile illness, or antibiotic use within 4 weeks of the Baseline visit.\n44. Vaccination within 14 days of the Baseline visit.\n45. Any severe hypoglycemic event since the screening visit.\n46. Poorly controlled hypertension, as evidenced by a mean of 3 separate blood pressure measurements \\>180 mmHg (systolic) or \\>100 mmHg (diastolic)\n47. Women of child-bearing potential with a positive urine pregnancy test at baseline visit.\n48. LA Grade C or greater esophagitis on endoscopy.\n49. Abnormalities of the GI tract preventing endoscopic access to the duodenum.\n50. Anatomic abnormalities in the duodenum or proximal jejunum that would preclude the completion of the treatment procedure, including tortuous anatomy.\n51. Endoscopic observation of upper gastrointestinal abnormalities such as ulcers, polyps in the area to be treated, varices, strictures, congenital or intestinal telangiectasia.\n52. Any other anatomical or endoscopic abnormalities\u002Fcharacteristics that, in the opinion of the investigator, would preclude safe use of the investigational device or procedure.","22 Years","75 Years",{"count":225,"type":21},320,[88],"This is a prospective, multicenter, randomized, double-blind, sham-controlled, adaptive study evaluating the pulsENDO system in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications (GLMs). The primary objective of this study is to demonstrate that pulsENDO therapy is superior to sham control for improving glycemic control in adults with type 2 diabetes.",[229,26,230,231,232,233],"Diabetes Type 2","Diabetes (DM)","Weight Change","Glycemic Control","Glycemic Control for Diabetes Mellitus",[235,236,237,238,239],"blinded","multicenter","randomized","doudenal regeneration","type 2 diabetes","2026-08-14",{"date":181,"type":36},{"date":243,"type":21},"2027-01-01",{"date":245,"type":21},"2030-11-01",{"name":247,"class":248},"Endogenex, Inc.","INDUSTRY",{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":56,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":44},"100454585","role-of-adiposomes-in-endothelial-dysfunction-100454585","NCT05199454","Role of Adiposomes in Endothelial Dysfunction","Role of Adiposomes in Diabetes-Associated Endothelial Dysfunction and Restorative Effects of Exercise and Metabolic Surgery","Inclusion Criteria:\n\n* BMI ≥ 35 kg\u002Fm2\n* Between ages 18-50 years\n* Not pregnant\n* Diabetic (Current use of diabetes medication or fasting glucose ≥126 mg\u002FdL)\n* Medical clearance to participate in a moderate-intensity exercise program\n\nExclusion Criteria:\n\n* Pregnant women\n* Current smokers\n* Currently abusing alcohol or drugs\n* Chronic heart, liver, or kidney diseases, autoimmune diseases, or cancer\n* Non-English speakers\n* History of allergic reactions to lidocaine","50 Years",{"count":258,"type":21},60,[88],"The development of type II diabetes (T2D) is strongly associated with obesity and both are well-established risk factors for cardiovascular disease. Knowing that vascular dysfunction is an early event in the development of cardiovascular disease in obese diabetic (OB-T2D) patients, The investigators set their long-term goal to define molecular mechanisms of vascular dysfunction and corrective strategies that target these mechanisms such as physical activity and weight loss. The investigators recently discovered that human adipose tissues release extracellular vesicles (adiposomes) that are efficiently captured by endothelial cells. Adiposomes are known to carry bioactive cargos such as proteins and micro RNAs; however, their lipid content has not been studied nor has their ability to transfer their lipid cargo to endothelial cells. In the current application, the investigators propose to investigate the role of adiposomes in communicating the unhealthy milieu, mainly dysregulated lipids, to endothelial cells in OB-T2D subjects. On top of these lipid species that the investigators propose to be carried by adiposomes are glycosphingolipids (GSLs). These lipids originate from the glycosylation of ceramides, a chemical process that is upregulated in the presence of inflammation and high glucose levels. Preliminary findings showed that in endothelial cells, GSL-rich adiposomes disturb plasma membrane structure and subsequently induce endothelial dysfunction. Moreover, the investigators found that preconditioning endothelial cells with high shear stress (which is an exercise mimetic) protected endothelial cells from the detrimental effects induced by adiposomes. Therefore, the central hypothesis is that adipose tissues in OB-T2D patients release GSL-loaded adiposomes that induce vascular endothelial dysfunction. The researchers propose that exercise and weight loss interventions (bariatric surgery) will restore adipose tissue homeostasis, reduce GSL-loaded adiposomes, and subsequently alleviate vascular risk in OB-T2D patients. The investigators will test the hypotheses by pursuing the following aims: aim 1: Investigate the role of GSL-rich adiposomes in the pathogenesis of endothelial dysfunction in OB-T2D adults; aim 2: Test the effectiveness of exercise training in reducing adiposome-mediated effects on vascular function; and aim 3: Examine changes in adiposome\u002Fcaveolae axis following metabolic surgery and their association with vascular function.",[25,26,262],"Cardiovascular Diseases",{"date":206,"type":36},{"date":265,"type":36},"2022-05-16",{"date":267,"type":21},"2026-12-31",{"name":269,"class":132},"University of Illinois at Chicago",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":84,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":278,"conditions":279,"keywords":282,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":4,"leadSponsor":290,"locationsCount":292},"100083273","personalized-environment-and-genes-study-100083273","NCT00341237","Personalized Environment and Genes Study","* INCLUSION CRITERIA\n\nIn order to be eligible for participation in this study, an individual must meet all of the following criteria:\n\n* Adults greater than or equal to 18 years of age\n* If female, must not be (self-reported as) pregnant. At the time of enrollment, a pregnancy test will only be done at the PI s discretion.\n* Able to understand and provide written informed consent\n* Able to come to the NIEHS Clinical Research Unit (CRU) for enrollment and study-related visits\u002Fprocedures.\n\nEXCLUSION CRITERIA\n\nAn individual who does not meet the inclusion criteria listed above is excluded from participation in this study.",{"count":277,"type":21},25000,"Despite the overwhelming focus on genetic and genomic causes of human disease over the past two decades, it has been estimated that genetics is currently known to explain only 20% and 40% of the etiology of common disease. Thus, it is becoming increasingly apparent that human disease is a consequence of both genetic susceptibility and environmental exposures. Importantly, while individuals cannot change their genetic composition, we do have the ability both personally and as a society, to influence our environment, promoting health and decreasing the risk of disease. The Personalized Environment and Genes Study (PEGS) aims to determine how the environment and gene-environment interactions can inform our understanding of human health and disease. As science has evolved, so too has the science of this project. This evolution was reflected in a change in the title of this project from the Environmental Polymorphisms Registry (EPR) to the Personalized Environment and Genes Study (PEGS) to more accurately reflect the science that can be conducted. PEGS is a unique resource because of the depth of environmental phenotyping which includes extensive information from exposome surveys, as well as whole genome sequencing on a significant number of participants in the cohort. While it is small relative to genomic cohorts, none of these have the extensive environmental data that is present in PEGS. In addition, other cohorts with deep environmental data lack the depth of genomic data that is present in PEGS. Importantly, PEGS has already provided important analytic advances that are of great interest to and can be confirmed in larger cohorts such as All of Us.\n\nThe Personalized Environment and Genes Study (PEGS) aims to provide a resource for environmental health translational research by examining gene-environment interactions in health and disease. PEGS is an extension of two previous efforts where it began as a pilot study, the Environmental Polymorphisms Study (EPS; IRB# 02E9004) and was approved subsequently as a full protocol titled the Environmental Polymorphisms Registry (EPR) (IRB #04-E-N0053 and transitioned to its current ID# 04-E-0053). The EPR was envisioned as a phenotype-by-genotype registry of participants who had donated DNA samples, and who had agreed to be contacted for follow-up clinical translational studies based on their DNA genotypes. At the time, the only information available was a participant s age, sex, race, and ethnicity. Further phenotyping of a participant and\u002For any biospecimens obtained were investigated during a follow-up translational clinical study on participants recruited based on their genotype (hence phenotype-by-genotype) and the PEGS was the first recruit-by- genotype study at the NIH. Following a period focused on recruiting approximately 15,000 participants to enable genotyping of rare (approximately 1% minor allele frequency) single nucleotide polymorphisms (SNPs), the PEGS Consortium Project was undertaken in 2010- 2011 to examine, using the DNA of nearly 4,000 participants, approximately 700 SNPs in approximately 80 environmental response genes that work in concert with environmental exposures to elicit a phenotype. Several clinical follow-up studies, genotype-phenotype association studies, and publications have resulted from the PEGS Consortium Project.\n\nTo expand phenotype information available to researchers, the Health and Exposure Questionnaire was administered between 2013-2014. In 2017, a more detailed Exposome Questionnaire which includes questions relating to the external and internal exposome was administered. This was an important resource through which to integrate exposures with genotype-phenotype association studies.\n\nWhole genome sequencing has now been performed on approximately 4700 participants who were reconsented for this purpose, as indicated above. Questionnaire data was fully adjudicated and combined in a robust and searchable database. With the increased power of the data available, the project was renamed as the Personalized Environment and Genes Study (PEGS) and rolled out in Sept. 2021.\n\n...",[26,280,281],"Heart Disease","Asthma",[283,284,285,286,152],"Genotype","Phenotype","Environmental Factor","Single Nucleotide Polymorphism",{"date":206,"type":36},{"date":289,"type":36},"2010-05-26",{"name":291,"class":43},"National Institute of Environmental Health Sciences (NIEHS)",2,{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":84,"sex":16,"minAge":52,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":301,"conditions":302,"keywords":304,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":4,"leadSponsor":311,"locationsCount":44},"100054784","diabetes-and-heart-disease-risk-in-blacks-100054784","NCT00001853","Diabetes and Heart Disease Risk in Blacks","* IINCLUSION AND EXCLUSION CRITERIA\n\nCRITERIA FOR INCLUSION:\n\nEthnicity: Black\n\nThis is a study of adult African Americans and Blacks that were born in Africa but are now living in the United States. As African American people are multi-ethnic, we will in this initial investigation, study two different groups of African American. To enroll participants must self-identify as African Americans and be born in the United States, with American born parents or be born in Africa with African born parents. In both groups we will study sex differences in the role of obesity and TG levels on cardiovascular disease. In the future, we plan to expand the study to include other groups which self-identify as African Americans (i.e.AfroCarribeans and Hispanic blacks).\n\nOnly blacks are included in this study because the focus of this study is on gender differences in blacks in risk factors for CAD, specifically obesity, TG levels and TG related CAD risk factors. Unlike Caucasian women, premenopausal black women do not appear to be as protected from heart disease as a result of their gender. One model to study this apparent decrease in gender\n\nrelated cardioprotection in black women is to compare black men to black women. An alternative model would be to compare black women to Caucasian women. However, since the primary focus of this work is on gender differences rather than racial differences comparing black women to men is a superior model. Other racial groups do not share the loss of gender-related cardioprotection found in blacks, and have been excluded. Further the advantage of comparing black men and women is that this comparison provides a better control of dietary, cultural and genetic factors.\n\nAge: The age range of the participants will be between 18 and 70 years. As stated in the original protocol on page 14: Future investigations are planned which will involve similar comparisons between premenopausal and postmenopausal black women and between whites and blacks. To investigate risk for glucose intolerance, diabetes and cardiovascular risk factors, it is no longer sufficient to maintain the age range between 18 and 50 years. We need to expand to an age range with an increased prevalence of these risk factors.\n\nMedical History: To participate in the study subjects should identify themselves as healthy. This is important so the broadest possible sample of people will enroll. The fact that people are healthy will be confirmed by the history, physical and laboratory tests done as part of the screening visit. People with established coronary artery as evidenced by history of myocardial infarction, coronary artery bypass surgery or PTCA will be allowed to participate if they are not currently having angina.\n\nCRITERIA FOR EXCLUSION:\n\nBlack Ethnicity other than American or African.\n\nAs stated in the inclusion criteria black people are a multi-ethnic group. In this initial investigation we are focusing on African Americans who are American born and Africans living in the United States who are African born. In the future, we will expand the study to include other groups of blacks such as individuals of Afro-Caribbean and Hispanic blacks.\n\nMedications: People who take medications that are known to alter the parameters which are under investigation in this study will be excluded. People taking medications to treat hyperlipidemia will be included but analyses will be adjusted to take this into account. Subjects on thyroid hormone replacement will be included if their TSH is normal.\n\nDiabetes: Because diabetes affects insulin sensitivity and TG levels all people with diabetes even if the diabetes is controlled with diet alone will not be enrolled in the study.\n\nPregnant or Breastfeeding: Women who are pregnant, breastfeeding, or have an infant that is less than four months of age will be excluded. This is because the physiologic changes associated with pregnancy, breastfeeding or recent childbirth affect the parameters under study.\n\nMenstrual History: Now that postmenopausal women are included, menstrual history will be taken but women with irregular menses and hysterectomy will not be excluded. Women between the ages of 40 and 55 years will have FSH checked for proper characterization. Women 56 years of age and older will be assumed to be postmenopausal. However, women on any type of injectable hormonal contraception will be excluded because hormonal contraception affects both TG levels and glucose metabolism.","70 Years",{"count":171,"type":21},"It is unknown if obesity contributes to the development of heart disease in African American men and women.\n\nThis study was created to determine whether there is a relationship between sex and body size and the incidence of heart disease in African American men and women. Researchers will attempt to associate obesity with the presence of heart disease risk factors. Risk factors that will be studied include; total body fat, body fat distribution, fat content of the blood (triglyceride concentration, low density lipoproteins \\[LDL\\], and high density lipoproteins \\[HDL\\]), how fast fat is removed from the blood, and how well insulin works in the body.\n\nScientific studies have shown that obesity and increased levels of fat content in the blood are important risk factors for heart disease in Caucasian women. However, similar studies in African American women have failed to show the same correlation. In fact, it appears that African American women in all three body weight groupings, nonobese, overweight, and obese experience high death rates due to heart disease. In addition, prior research has shown that obese African American men tend to have elevated levels of fat in the blood while African American women have normal blood fat levels. Therefore, if high levels of triglycerides (fat found in the blood) are not seen in non-diabetic obese African American women, it cannot be considered a risk factor in this population. This suggests that studies conducted on Caucasian women may not provide insight into heart disease risk factors in African American women.\n\nThe study will take 2000 healthy non-diabetic African American men and women (ages 18-70) and body mass index 3 subgroups; nonobese, overweight and obese. Diabetes undeniably increases the risk of heart disease. Therefore patients suffering from diabetes will not be included in the study. Candidates for the study will undergo a series of tests and examinations over 2 outpatient visits. Subjects will have body fat analyses, resting energy expenditure measurements, an EKG (electrocardiogram), and specific blood tests.\n\nResearchers believe this study will provide significant insight into the causes of obesity and heart disease in African Americans.",[262,26,25,303],"Hypertension",[305,306,26,307,152],"Healthy Volunteers","Health Disparities","Cardiovascular Disease",{"date":206,"type":36},{"date":310,"type":36},"1998-10-21",{"name":42,"class":43},{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":56,"phases":322,"briefSummary":323,"conditions":324,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":44},"100652296","rowing-and-cycling-reduce-inflammation-in-early-stage-type-2-diabetes-100652296","NCT07769840","Rowing and Cycling Reduce Inflammation in Early-Stage Type 2 Diabetes","Effects of Different Modes of Rowing Combined With Cycling Exercise on Inflammatory Markers in Newly Diagnosed Type 2 Diabetes Patients","Inclusion Criteria:\n\n1. Age between 18-60 years, no gender limited;\n2. Meeting the WHO 1999 diagnostic criteria for T2DM, with a diagnosis time ≤12 months;\n3. Not having received hypoglycemic drug treatment (or only lifestyle intervention, and stopped medication ≥4 weeks before enrollment);\n4. Fasting blood glucose 7.0-13.9 mmol\u002FL, glycated hemoglobin (HbA1c) 6.5%-10.0%;\n5. No regular exercise in the past 3 months (less than 2 times per week of moderate or higher intensity exercise, each \\\u003C30 minutes);\n6. Voluntarily signing the informed consent form.\n\nExclusion Criteria:\n\n1. Type 1 diabetes, gestational diabetes, or other special types of diabetes;\n2. Severe cardiovascular or cerebrovascular diseases (NYHA heart function ≥III, recent myocardial infarction or unstable angina);\n3. Uncontrolled hypertension (resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);\n4. Severe liver or kidney dysfunction (ALT\u002FAST ≥3 times the upper limit of normal, or eGFR\\\u003C60 mL\u002Fmin\u002F1.73m²);\n5. Severe diabetic complications (such as proliferative retinopathy, severe neuropathy, diabetic foot);\n6. Pregnant or breastfeeding women;\n7. Mental illness or cognitive impairment that prevents compliance with the study;\n8. Stress events such as infection, trauma, or surgery in the past month;\n9. Participation in other interventional clinical studies;\n10. Musculoskeletal diseases of the upper or lower limbs that affect rowing machine or bicycle exercise.","60 Years",{"count":321,"type":21},120,[88],"This multicenter randomized controlled trial evaluates the short-term (7-day) effects of different rowing-cycling exercise regimens on postprandial glycemic excursions in newly diagnosed type 2 diabetes patients (aged 18-60 years, diagnosis ≤12 months, drug-naïve). A total of 120 participants will be randomized into five groups: control, moderate-intensity continuous cycling, high-intensity interval rowing, and standard combined exercise (rowing + cycling, 50 min). The primary outcome is inflammatory cytokines (IL-6, TNF-α, IL-1β, IL-1ra, IL-10, hs-CRP), body Composition and functional Indicators. Secondary outcomes include change in continuous glucose monitoring-derived glycemic variability (CONGA), and time-in-range. Mixed-effects models will quantify dose-response relationships and identify key effect modifiers (e.g., age). This study aims to establish an evidence-based precision exercise prescription for early-stage type 2 diabetes management.",[26],"2026-08-12",{"date":181,"type":36},{"date":328,"type":21},"2026-10-01",{"date":330,"type":21},"2028-12-11",{"name":332,"class":132},"The 95th Hospital of Putian，Putian, Fujian, China",{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":16,"minAge":340,"maxAge":299,"enrollmentInfo":341,"targetDuration":4,"studyType":56,"phases":343,"briefSummary":344,"conditions":345,"keywords":346,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":357,"leadSponsor":359,"locationsCount":4},"100545273","using-healthcare-financing-and-digital-technology-to-improve-hypertension-prevention-and-control-in-tanzania-100545273","NCT06379750","Using Healthcare Financing and Digital Technology to Improve Hypertension Prevention and Control in Tanzania","STOP NCDs: Scaling up Evidence-based Health System Interventions Through the Use of Sustainable Healthcare Financing and Digital technOlogy Platforms to Improve Non- Communicable Disease Prevention and Control in Tanzania","Inclusion Criteria:\n\n* All adults with uncontrolled HTN who receive care through iCHF membership and are able to provide informed consent.\n\nExclusion Criteria:\n\n* Adults with controlled HTN or those without a diagnosis of HTN\n* Unable or unwilling to provide informed consent","21 Years",{"count":342,"type":21},1320,[88],"The aim of our proposed program is to develop and implement a multilevel, multicomponent and health-financing intervention that will facilitate the scale up of evidence-based strategies to improve non-communicable diseases prevention, detection and control in Tanzania. The investigators will accomplish this by: 1) adapting two intervention components that are candidates for inclusion in a highly effective optimized strategy (called STOP-NCDs) and; (b) Assess their individual and combined effectiveness and 2) conducting a robust, mixed-methods evaluation of the implementation process and assess factors that may influence implementation and sustainability for delivering and scaling the optimized STOP-NCDs strategy. The investigators will select and\u002For adapt intervention components making up the optimized STOP-NCDs strategy. Using a hybrid clinical-effectiveness implementation design, the investigators will conduct a study in 2 sequential phases: 1) A clinical-effectiveness phase in which the investigators evaluate the effect of our combined strategies (task-sharing and WelTel) versus Usual Care, on rates of systolic BP reduction at 12 months; as well as other secondary outcomes including diagnosis and treatment of diabetes and, patient knowledge of CVD risks and prevention, and, other features of health provider NCD prevention activities. 2) A post-implementation phase in which the investigators use the RE-AIM framework to evaluate changes in the adoption and maintenance of our combined strategies in participating iCHF health facilities across Kilimanjaro region. The investigators will use the WelTel communication and Patient Management platform for to deliver culturally and contextually appropriate evidence-based text messaging to patients. It allows for quality improvement and is a unique tool for our program to scaling low-cost interventions that provide capabilities for tracking of health system service uptake, quality-metrics at health facilities, drug stock-out management, and patient-centered behavioral health interventions. Deployment of WelTel will allow for integration of NCD prevention targeted health services to all adult iCHF members across differing life stages and NCD risk and have a significant impact on increasing quality of care and sustainability of health financing and performance-based incentives through improved prescribing, patient engagement, medication adherence and healthy behaviour change.",[303,26],[347,348,349,350,351,352],"hypertension","diabetes","NCD management","NCD prevention","mHealth","healthcare financing","2026-08-10",{"date":355,"type":36},"2026-08-11",{"date":328,"type":21},{"date":358,"type":21},"2028-03-01",{"name":360,"class":132},"Queen's University",{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":84,"sex":369,"minAge":370,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":56,"phases":373,"briefSummary":374,"conditions":375,"keywords":378,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":44},"100619937","improving-cervical-cancer-prevention-among-women-living-with-chronic-conditions-100619937","NCT07351110","Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions.","Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions. Aim 3: Assess the Feasibility and Acceptability of the PINPOINT Intervention.","PINPOINT","Inclusion Criteria:\n\nThe following eligibility criteria will be used to determine inclusion into the study:\n\n1. Using the American Cancer Society (ACS) screening recommendations, adults aged over the age of 25 will be eligible\n2. Active UF Internal Medicine patient and has had an appointment in the last 2 months.\n3. Assigned sex at birth is female\n4. Have Obesity or Type 2 Diabetes\n5. Not currently pregnant (self-report)\n6. Have not given birth in the prior 12 weeks\n7. No previous history of cervical cancer\n8. No previous history of a hysterectomy\n9. Have not undergone cancer screening in the past 3 years or more\n10. Reside in the UFHCI Catchment Area (Alachua, Baker, Bradford, Citrus, Clay, Columbia, Dixie, Gadsden, Gilchrist, Hamilton, Jefferson, Lafayette, Lake, Leon, Levy, Madison, Marion, Putnam, Sumter, Suwannee, Taylor, UnioF1n, or Wakulla County).\n11. Have a mobile phone or access to a mobile phone that can be used to receive messages, or a valid email address.\n12. Are not currently scheduled to receive cervical cancer screening via clinician sampling (pap smear).\n\nExclusion Criteria:\n\n* Previous history of cervical cancer\n* Total hysterectomy\n* Pregnant","FEMALE","25 Years",{"count":372,"type":21},20,[88],"Our overarching goal is to adapt and test the PINPOINT intervention -PatIent Navigation for the Prevention of CervIcal CaNcer inTervention. We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer.",[26,376,377],"Cervical Cancer (Early Detection)","Obesity & Overweight",[379,380,381],"cervical cancer screening","self-collection","self-sampling","2026-08-06",{"date":353,"type":36},{"date":385,"type":21},"2026-08-30",{"date":387,"type":21},"2028-03-31",{"name":389,"class":132},"University of Florida",{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":84,"sex":16,"minAge":52,"maxAge":169,"enrollmentInfo":397,"targetDuration":4,"studyType":56,"phases":399,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":412},"100597681","expanding-the-support-of-family-caregivers-of-diverse-patients-with-cancer-and-diabetes-100597681","NCT07061652","Expanding the Support of Family Caregivers of Diverse Patients With Cancer and Diabetes","enCompass","Inclusion Criteria:\n\nInclusion Criteria for Caregivers\n\n* English-speaking.\n* Ability to provide written or verbal informed consent to participate in the study;\n* Willing and able to comply with study procedures based on the judgment of the investigator or protocol designee;\n* Be at least 18 years of age at the time of consent; and\n* Identify as an informal (unpaid) caregiver for an adult with a stage II-IV cancer AND diabetes.\n\nInclusion Criteria for patients\n\n* English-speaking\n* Ability to provide informed consent.\n* Be at least 18 years of age at the time of consent; and\n* Their identified caregiver is enrolled in the study\n* Diagnoses: (must have cancer and diabetes)\n* Have a cancer diagnosis for which they are being actively treated at one of the study sites\n* Have a cancer diagnosis, stage II-IV solid tumor or any hematologic malignancy\n* Receiving active cancer treatment s, not including hormonal therapy\n* Concurrent history of diabetes with need for ongoing management\n\nExclusion Criteria:\n\nExclusion Criteria for Caregivers\n\n* Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;\n* Existence of another co-morbid disease other than diabetes, which in the opinion of the investigator, prohibits participation in the protocol;\n* Participation in the intervention development phase of this intervention\n\nExclusion Criteria for patients\n\n* Self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;\n* Existence of other co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol;\n* Their caregiver does not enroll in the study or withdraws consent",{"count":398,"type":21},162,[88],"This study investigates the feasibility, acceptability, and preliminary efficacy of enCompass Humana, a social support intervention for caregivers of patients with cancer and diabetes. The enCompass program aims to improve support for these caregivers through a randomized feasibility study of a pilot-tested coaching and navigation program.\n\nCaregiver services and system-level support are essential, but successful interventions for cancer caregivers are rarely standardized or systematically disseminated. Consequently, many programs do not reach the most underserved caregivers. Challenges to implementation include substantial clinical staff involvement, lack of dissemination and implementation information, and failure to tailor interventions to rural contexts. Despite the lack of standardized supportive interventions, national reports and legislative efforts increasingly recognize the need to support caregivers.\n\nCaregivers reported unmet needs in all domains of social support, including instrumental help (e.g., in-home help, housekeeping), logistical and coordination support (e.g., food delivery, accompanying patients to appointments), information about illness and progression, emotional support, self-care guidance, and financial assistance (e.g., parking costs, lost wages). Caregivers show high interest in services but cited uncertainty and lack of strategies for accessing resources. Many are unaware of existing services. Interviews with oncology clinicians and healthcare administrators revealed similar findings: resources exist, but there is no system to match them with caregivers' needs.\n\nPreliminary data suggest the intervention improves caregiver coping self-efficacy and reduces anxiety and depression in patients. With input from stakeholders, including caregivers, patients, family caregiving experts, and clinical care experts, the study team adapted the CARING application into enCompass to mitigate structural barriers and normalize support-seeking. The long-term goal is to adapt this psychosocial support program to increase self-efficacy, support-seeking, and reduce loneliness among caregivers. It is hypothesized that enCompass will build self-efficacy and coping skills, serving caregivers throughout the patient's illness and complications.",[174,26],[403,404],"support application","caregivers",{"date":353,"type":36},{"date":407,"type":36},"2025-07-03",{"date":409,"type":21},"2027-05-01",{"name":411,"class":132},"UNC Lineberger Comprehensive Cancer Center",3,{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":140,"enrollmentInfo":419,"targetDuration":4,"studyType":56,"phases":421,"briefSummary":422,"conditions":423,"keywords":424,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":44},"100481377","effect-of-2-week-continuous-glucose-monitoring-on-glycemic-management-in-patients-new-to-insulin-on-hospital-discharge-100481377","NCT05548205","Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge","Inclusion Criteria:\n\n1. Male or female aged 18-100 years\n2. Known history of type 1 or type 2 diabetes\n3. Admitted to NYU Langone Hospital - Long Island between December 16, 2024- December 31, 2026\n4. New initiation of insulin therapy, including basal insulin regimen, basal-bolus insulin regimen, or mixed insulin regimen at the time of hospital discharge\n\nExclusion Criteria:\n\n1. Prior to admission use of home insulin therapy\n2. Current use of systemic corticosteroids\n3. Active pregnancy; as pregnancy requires different blood glucose targets, subjects known to be pregnant will be excluded from this study. Subjects will not be tested for pregnancy outside of testing performed in routine medical care; pregnancy will be determined by patient self-reporting. Females of childbearing potential will not be instructed to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.",{"count":420,"type":21},150,[88],"The proposed study will be a randomized, prospective, non-blinded study of 120 participants with type 1 or type 2 diabetes that are new-to-insulin on hospital discharge. On hospital discharge, participants will be assigned to either the intervention of wearing a continuous glucose monitor (CGM) for 2 weeks or blood glucose monitoring (BGM) for 2 weeks. They will have a 2-week follow up visit, during which insulin doses will be adjusted as needed, and a 3-month follow-up visit, at which point HbA1c will be measured.",[26],[425],"Continuous Glucose Monitoring (CGM)",{"date":427,"type":36},"2026-08-07",{"date":429,"type":36},"2024-12-16",{"date":431,"type":21},"2027-04-30",{"name":433,"class":132},"NYU Langone Health",{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":56,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":44},"100430638","exciflex-electroceutical-banadage-for-chronic-wound-therapy-100430638","NCT04887688","Exciflex Electroceutical Banadage for Chronic Wound Therapy","Toward Smart Personalized Electrotherapy for Enhanced Healing of Chronic Wounds","Inclusion Criteria:\n\n* All participants with chronic wounds treated at LSCVAMC will be potentially eligible for the study\n* Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long-Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care\n\nExclusion Criteria:\n\nIn addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include:\n\n* Pregnancy",{"count":442,"type":21},16,[88],"Objectives: The study objective is to carry a pilot clinical assessment comparing the exciflex bandage to standard of care (SoC) for ischemic wounds and will involve participants who are Veterans with lower extremity ischemic wounds.\n\nResearch Plan: The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of exciflex in clinical use.\n\nMethodology: All participants with chronic ischemic wounds treated at Louis Stokes Cleveland VA Medical Center (LSCDVAMC) will be potentially eligible for the study. Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care. In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include; (1) Age less than 18 years and (2) Pregnancy.\n\nClinical Significance: Chronic ischemic wounds fail to heal normally and are a major challenge in the long-term care of many Veterans. The exciflex bandage can improve outcomes and lower cost by automatically delivering electrotherapy without disturbing the wound dressing for up to seven days, unless indicated. The overall study goal is to complete pre-market testing and evaluation of the exciflex bandage system.",[446,26,447,448],"Chronic Wound","Spinal Cord Injury","Ischemic Wound",{"date":353,"type":36},{"date":451,"type":36},"2022-10-05",{"date":453,"type":21},"2029-09-30",{"name":101,"class":102},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":84,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":464,"conditions":465,"keywords":466,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":473,"locationsCount":44},"100313876","taste-bud-derived-stem-cells-in-humans-100313876","NCT03366168","Taste Bud-Derived Stem Cells in Humans","A Pilot Study of Taste Bud-Derived Stem Cells in Humans","* INCLUSION CRITERIA:\n* Age 18 years and older\n* Healthy (see exclusion criteria below)\n* Are able to understand the study risks and procedures, and consent to participate in the study.\n* Are able to read and speak English.\n\nEXCLUSION CRITERIA:\n\n* Have less than 40 fungiform papillae on the anterior third portion of the tongue as evidenced by tongue photo taken during the screen visit.\n* Does not agree to the use of their tissue samples to produce stem cells.\n* A medical condition that requires the use of chronic anticoagulant medication use such as warfarin, clopidogrel, heparin or antiplatelet agents other than low dose aspirin (81mg).\n* History of increased bleeding due to either a known medical condition or an undiagnosed cause.\n* Active infections or chronic conditions that would prevent access to the biopsy area.\n* Taking non-steroidal anti-inflammatory agents (NSAIDs) such as Motrin (Ibuprofen), Advil (Ibuprofen) or Naprosyn (Naproxen) and the participant is unable to stop taking them 4 days before and 3 days after the final biopsy procedure.\n* Taking more than 81 mg of aspirin a day and the participant is unable to stop taking it for 4 days before and 3 days after the biopsy procedure.\n* Allergic to Lidocaine (Xylocaine) or any other local anesthetic or the participant has had in the past a severe allergic reaction to similar drugs.\n* Have taken steroids, other than ocular within 30 days of their scheduled biopsy procedure.\n* HIV virus infection.\n* Hepatitis B or C.\n* Kidney disease (Creatinine greater than1.5 mg\u002Fdl or calculated creatinine clearance less than 50 cc\u002Fmin).\n* Liver disease (ALT, AST or alkaline phosphatase twice the normal serum concentration).\n* Severe gastrointestinal diseases such as Crohn s disease or ulcerative colitis requiring continuous treatment.\n* History of severe pulmonary disease such as chronic obstructive pulmonary disease (COPD) or asthma requiring continuous medication use.\n* History of using any tobacco products within the past six months.\n* History of severe psychiatric conditions associated with behavioral problems or requiring chronic medical treatment.\n* Currently pregnant or breastfeeding.\n* Current illness that as judged by the study physician substantially increases the risks associated with the tongue biopsy (active infections, allergies, etc.).",{"count":463,"type":21},250,"Background:\n\nStem cells are found in body tissues. They can regenerate into more of the same cells or become other types of cell. Researchers want to use stem cells from taste buds to try to make cells that secrete insulin. Taste buds are found mostly on the tip and sides of the tongue. Researchers also want to study if the number of taste buds and stem cells decrease as people age. They will remove small pieces of tongue tissue (about the size of a pen tip). The taste buds will grow back. It is hoped that studying taste bud stem cells can lead to new diabetes treatments.\n\nObjectives:\n\nTo see if stem cells from taste buds can be isolated in humans.\n\nEligibility:\n\nHealthy adults at least 18 years old\n\nDesign:\n\nParticipants will be screened with:\n\n* Medical history\n* Physical exam\n* Blood and urine tests\n* Tongue photograph and mouth inspection. Food coloring will be applied to the tongue.\n\nParticipants will have 1 study visit. They will not eat or drink anything 8 hours before.\n\n* They will give blood and urine samples.\n* They will have a tongue biopsy. Vital signs will be checked. The inside of the mouth will be examined. The tongue may be cleaned. The tongue will be numbed. Five small pieces of tissue will be taken with a small scissor. Any bleeding will be blotted with cotton and should stop in minutes.\n* Participants will be monitored for about 30 minutes. They will get a snack or meal.\n* They will be told how to take care of the tongue for the rest of the day.\n\nParticipants will be called a week later to see how the",[26],[26,467,468,152],"Fungiform Papillae","Insulin",{"date":427,"type":36},{"date":471,"type":36},"2017-12-18",{"date":267,"type":21},{"name":474,"class":43},"National Institute on Aging (NIA)",{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":84,"sex":16,"minAge":52,"maxAge":18,"enrollmentInfo":482,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":484,"conditions":485,"keywords":486,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":4,"leadSponsor":494,"locationsCount":44},"100063220","urinary-vitamin-c-loss-in-diabetic-subjects-100063220","NCT00071526","Urinary Vitamin C Loss in Diabetic Subjects","Urinary Vitamin C Loss in Subjects With and Without Diabetes","* INCLUSION CRITERIA:\n\nTo be included in the study, study subjects should be:\n\n* Aged 18-65 years.\n* Either:\n\n  * Have no diagnosis of diabetes: \"nondiabetic controls\", or\n  * Have a diagnosis in their medical history of either Type 1 or Type 2 diabetes\n\nEXCLUSION CRITERIA (for outpatient study, arm 1)\n\nExclusion criteria will include the following:\n\n* Unable or unwilling to provide a signed and dated informed consent form\n* Unable or unwilling to comply with study procedures and lifestyle considerations\n\nEXCLUSION CRITERIA (for inpatient studies, arms 2 and 3)\n\nStudy participants interested in participating in Arms 2 and\u002For 3 will be excluded from this further participation if they meet any of the following:\n\n* significant organ malfunction leading to clinical instability including liver disease, pulmonary disease, ischemic heart disease, heart failure, stroke, peripheral vascular disease, and anemia at investigator discretion\n* other serious or chronic illness; history of serious or chronic illness; coronary artery disease, or peripheral vascular disease resulting in clinical instability\n* pregnancy or lactation\n* presence of other conditions which, in the judgment of the investigators, can influence vitamin C metabolism or vitamin C renal handling",{"count":483,"type":21},5000,"Several studies have reported that diabetic subjects have lower plasma vitamin C concentrations than non-diabetic subjects. Although urinary vitamin C loss in diabetic subjects was reported to be increased in two studies, these are difficult to interpret due to lack of controlled vitamin C intake, inadequate sampling, lack of control subjects, or methodology uncertainties in vitamin C assay and sample processing. Consequently, it is unclear whether diabetic subjects truly have both low plasma and high urine vitamin C concentrations. We propose that low plasma vitamin C concentrations in diabetic subjects are due in part to inappropriate renal loss of vitamin C in these subjects but not in healthy controls. We will study nondiabetic controls and cohorts with diabetes. Vitamin C concentrations in plasma, RBCs, and urine will be measured in outpatients. In those willing to be admitted to the Clinical Center, we will measure vitamin C pharmacokinetics to determine the relative bioavailability for vitamin C in individuals with and without abnormal urinary loss of vitamin C (or renal leak). Single nucleotide polymorphisms (SNPs) will be determined in genomic DNA responsible for the two proteins mediating sodium dependent vitamin C transport, SVCT1 and SVCT2. We will also explore mechanisms underlying abnormal urinary vitamin C loss.",[26],[487,488,489,490,64],"Renal Threshold","Diabetes Mellitus","Proteinuria","Plasma Concentrations",{"date":427,"type":36},{"date":493,"type":36},"2006-04-11",{"name":42,"class":43},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":56,"phases":505,"briefSummary":506,"conditions":507,"keywords":508,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":516,"leadSponsor":518,"locationsCount":44},"100644914","leveraging-interventions-for-needs-and-knowledge-in-diabetes-linkd-100644914","NCT07676188","Leveraging Interventions for Needs and Knowledge in Diabetes (LINKD)","Improving Diabetes Outcomes and Health Disparities by Addressing Unmet Resource Needs- A Sequential Multiple Assignment, Randomized Trial","LINKD","Inclusion Criteria:\n\nParticipants:\n\n* Age: 18 years of age or older\n* Diabetes diagnosis: Documented diagnosis of diabetes (Type 1 or Type 2) with prescribed anti-hyperglycemic medication\n* Glycemic control: Most recent (within the past 6 months) recorded hemoglobin A1c (HbA1c) level of: ≥7.5% for individuals ≤70 years of age and ≥8.0% for individuals between 70-75 years of age Prior study participation: Did not participate in the CareAvenue trial (R01DK116715)\n* Financial burden and\u002For social needs (meeting ONE or more of the following):\n\nPositive report of financial burden using validated screening questions; Medicaid or dual Medicare\u002FMedicaid coverage; Income ≤250% of the federal poverty level; Self-identified as ALICE (Asset-Limited, Income-Constrained, Employed): income above Medicaid threshold but reporting difficulty affording basic needs; Underinsured: high-deductible plan (≥$1,500 individual\u002F$3,000 family) with self-reported difficulty affording healthcare costs; Positive screen for one or more social risk factors on PRAPARE or equivalent (food insecurity, housing instability, transportation barriers, utility insecurity);\n\n* Financial decision-making: Self-identifies as primarily responsible for making own healthcare financial decisions (to address concerns about young adults dependent on family support).\n* Interest in assistance: Expresses interest in receiving assistance with unmet social needs.\n* Ability to participate: Able to complete the screening process in English (or Spanish\u002FArabic if materials available) on behalf of self.\n* Healthcare access: Receives or is able to receive care at Michigan Medicine (required for potential social worker referral).\n\nPeer Supporters:\n\n* Age: 18 years of age or older\n* Diabetes diagnosis: Self-reported diagnosis of diabetes (Type 1 or Type 2)\n* Glycemic control: Within the past 12 months, have had at least one hemoglobin A1c (HbA1c) level of: ≥7.5% for individuals ≤70 years of age and ≥8.0% for individuals ≥71 years of age AND A1c levels \\\u003C7.5% for individuals ≤70 years of age and \\\u003C8.0% for individuals ≥71 years of age\n* Experience navigating social or financial resources: Self-reported success in navigating financial assistance or social services resources\n* Ability to participate: Able to provide peer support in English (option to additionally provide support in Spanish and\u002For Arabic); Able to complete training; Able to make calls every other week with assigned participants; Able to submit call logs; Able to complete a brief survey about experience throughout participation.\n* Confidence in diabetes self-management: Self-reported confidence in ability to manage diabetes\n\nExclusion Criteria:\n\nParticipants:\n\n* Serious psychiatric disorder: Active diagnosis of schizophrenia, active psychosis, or other serious mental illness that would impair ability to engage in intervention (as determined by medical record review)\n* Cognitive impairment: Documented moderate to severe cognitive impairment that would prevent meaningful participation in study activities (as determined by medical record review)\n* Active substance use: Current active illicit drug use that would interfere with study participation (as determined by medical record review)\n* Pregnancy: Currently pregnant or planning pregnancy during the study period (due to expected A1c changes) (as determined by medical record review)\n* Glucose-altering medications: Currently taking medications that alter glucose metabolism as a side effect rather than for diabetes management, including: Chronic oral corticosteroids (≥2 weeks continuous use); Antipsychotic medications known to affect glucose; Other medications affecting glucose when NOT prescribed for diabetes management Note: GLP-1 agonists, SGLT2 inhibitors, and other diabetes medications are NOT excluded, regardless of whether they are also used for weight management\n* Limited life expectancy: Self-reported or documented comorbidity expected to limit life span to less than 3 years\n* Concurrent diabetes study participation: Currently enrolled in another diabetes intervention study\n* Institutionalized: Currently residing in a nursing home, assisted living facility, correctional facility, or another group setting that prevents them from participating on their own behalf\n\nPeer Supporters:\n\n* Cognitive impairment: Self-reported cognitive impairment that would prevent meaningful participation in study activities\n* Participation Concerns or Barriers: Self-reported concerns that would prevent meaningful participation in study activities\n* Limited life expectancy: Self-reported or documented comorbidity expected to limit life span to less than 3 years\n* Institutionalized: Currently residing in a nursing home, assisted living facility, correctional facility, or another group setting that prevents them from participating on their own",{"count":504,"type":21},694,[88],"Unmet social needs and economic burden persist as key reasons why one-third of people with diabetes have poor disease control. The purpose of this study is to learn whether different tools and types of support may help people manage diabetes and related challenges. The study will compare several approaches to understand how they affect people's experiences and health over time. Completion of the study aims will lead to an optimized intervention to improve the health and social well-being of people with diabetes.\n\nParticipants will be randomly assigned to one or more interventions aimed at addressing social and financial needs and will complete multiple surveys over the course of a year. The study team will collect information about their blood pressure and HbA1c (blood glucose).\n\nFindings will advance the field by determining the effectiveness of supportive interventions to address both social needs and diabetes self-care, and by informing protocols for the optimal sequencing of these strategies, a critical evidence gap in healthcare settings.",[26],[26,509,150,510,511],"Intervention Strategies","Financial Support","Disease Management","2026-08-03",{"date":514,"type":36},"2026-08-05",{"date":512,"type":36},{"date":517,"type":21},"2030-07-31",{"name":519,"class":132},"University of Michigan",{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":56,"phases":529,"briefSummary":530,"conditions":531,"keywords":540,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":44},"100626901","families-implementing-good-health-traditions-for-life-100626901","NCT07441655","Families Implementing Good Health Traditions for Life","FIGHT for Life","Inclusion Criteria:\n\n1. Family 1.a.) Black Parent\u002FGuardian: age 18 years or older residing in the same household with child (i.e., biological or have legal guardianship for child) 1.b.) Child: age 8-15 years old\n2. Parent\u002FGuardian have HbA1c level 5.7-6.4% (prediabetes)\n3. Parent\u002FGuardian willing to commit to participation in a 20-month research study and have no plans to move from the area over the next 20-months\n4. Parent\u002Fchild are ambulatory and able to participate in physical activity\n\nExclusion Criteria:\n\n1. Individuals with severe psychological disorders that may prevent\u002Finterfere with study participation\n2. Physical impairments that may prevent participation in moderate intensity physical activity;\n3. Previous diagnosis of diabetes\n4. History of congestive heart failure, renal failure, or recent (\\\u003C12 months) cardiovascular events such as myocardial infarction or stroke;\n5. Person taking medications that may affect endpoint analyses\n6. Persons with co-morbid contraindications to physical activity or dietary changes.\n7. Currently pregnant or planning to become pregnant in the next year.",{"count":528,"type":21},70,[88],"This study will provide evidence for the utility of using a community-engaged research approach to implement a tailored, family-oriented adaptation of the Diabetes Prevention Program that will have positive effects on risk factors associated with type 2 diabetes morbidity and mortality among Black families in a Southwest Georgia community.",[26,532,533,534,535,536,537,538,539],"Chronic Disease","Type 2 Diabetes","Healthy Lifestyle","Nutrition, Healthy","Sedentary Behavior","Family","Family Research","Family and Household",[348,541,239,542,543,544,545,546,547,548],"rural","nutrition","physical activity","diabetes prevention","family research","family and household","chronic disease","sedentary behavior",{"date":514,"type":36},{"date":551,"type":36},"2026-02-01",{"date":553,"type":21},"2028-07-31",{"name":555,"class":132},"Morehouse School of Medicine",{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":84,"sex":16,"minAge":52,"maxAge":140,"enrollmentInfo":563,"targetDuration":4,"studyType":56,"phases":565,"briefSummary":566,"conditions":567,"keywords":570,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":44},"100163351","new-heart-imaging-techniques-to-evaluate-possible-heart-disease-100163351","NCT01399385","New Heart Imaging Techniques to Evaluate Possible Heart Disease","Magnetic Resonance of Body, Arterial Wall, and Angiography Imaging for Non- Invasive Assessment of Arterial Distensibility, Endothelial Dysfunction and Atherosclerotic Disease Using 1.5T and High Field (3T) MRI: A Technical Development Study of Cardiac and Body Imaging","* INCLUSION:\n\n  1. Subjects with or without history of cardiovascular diseases and with various degrees of cardiovascular risk factor. Subjects with known or suspected atherosclerotic disease based on clinical findings or documented by angiography (conventional, CTA or MRA), or Doppler ultrasound. And, healthy volunteers and subjects with known or suspected diseases affecting the thoracic organs, abdominal organs, and other organs affected by metabolic diseases such as body fat and muscles. Subjects at risk for atherosclerosis including: smoking, obesity, hyperlipidemia, low levels of high density lipoproteins (\\\u003C50 mg\u002Fdl for women and \\\u003C40 mg\u002Fdl for men), hypertension, family history (early onset atherosclerosis \\\u003C55 year old in male and \\\u003C 65 year old in female who is first degree relative), and diabetes mellitus or metabolic syndrome.\n  2. Subject must be willing to participate in the protocol.\n  3. Subject age greater than 18 years old.\n  4. Subject must be able to provide informed consent.\n  5. Subject must be clinically stable and be able to come to the Clinical Center to participate in the study.\n\nEXCLUSION CRITERIA:\n\n1. Subjects with contraindication to MRI scanning. These contraindications include but are not limited to the following devices or conditions:\n\n   1. Implanted cardiac pacemaker or defibrillator\n   2. Cochlear Implants\n   3. Ocular foreign body (e.g. metal shavings)\n   4. Embedded shrapnel fragments\n   5. Central nervous system aneurysm clips\n   6. Implanted neural stimulator\n   7. Medical infusion pumps\n   8. Any implanted device that is incompatible with MRI.\n2. Unsatisfactory performance status as judged by the referring physician such that the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and dyspnea at rest.\n3. Subjects requiring sedation for MRI studies.\n4. Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.).\n5. Pregnant or lactating women.\n6. Subjects with severe back-pain or motion disorders who will be unable to tolerate supine positioning within the MRI scanner and hold still for the duration of the examination.\n7. Subjects who are unable to undergo a CTA within 2 months of the MRA part of this study, or are unable to undergo or be scheduled for a cardiac catheterization within 2 months of the MRA.\n\nEXCLUSION CRITERIA - FOR GADOLINIUM BASED MRI STUDIES ONLY:\n\n1. History of allergic reaction to gadolinium contrast agents despite the use of premeditation with an anti-histaminic and cortisone.\n2. eGFR \\\u003C 60 ml\u002Fmin\u002F1.73m\\^2\n\nEXCLUSION CRITERIA - FOR CORONARY CTA:\n\n1. Contraindication to the use of CTA contrast agents:\n\n   1. Creatinine value \\> 1.4 mg\u002Fdl\n   2. History of multiple myeloma\n   3. Use of metformin-containing products less than 24 hrs prior to contrast administration\n   4. History of allergic reaction to CTA contrast agents despite the use of pre- medication with an anti-histaminic and cortisone.\n2. Subjects with contraindication precluding the use of beta blockers necessary to perform the coronary CTA. These include:\n\n   1. Asthma\n   2. Active bronchospasm\n   3. Moderate or severe COPD\n   4. 2nd or 3rd degree AV block\n   5. Decompensated cardiac failure\n   6. Allergy to beta blockers\n   7. Systolic blood pressure \\\u003C 100 mm Hg\n   8. Pregnancy or nursing\n\nEXCLUSION CRITERIA - FOR NITROGLYCERIN USE:\n\nSubjects reporting a history of the following conditions will be excluded:\n\n1. Severe aortic stenosis\n2. Hypertrophic cardiomyopathy\n3. Inferior myocardial infarction with right ventricular involvement\n4. Cardiac tamponade\n5. Constrictive pericarditis\n6. Severe hypotension (systolic BP \\\u003C90 mmHg)\n7. Uncorrected hypovolemia\n8. Raised intracranial pressure\n9. Glaucoma\n10. Severe anemia\n11. Concomitant use of phosphodiesterase-5 inhibitors (sildenafil-Viagra, tadalifil-Cialis, verdenafil-Levitra)\n12. History of hypersensitivity to nitroglycerin",{"count":564,"type":21},4000,[88],"Background:\n\n\\- Imaging tests, such as magnetic resonance imaging (MRI), can provide information about heart and blood vessels. The tests let doctors can see the amount of blood vessel narrowing and vessel wall thickness. This information may help diagnose and treat heart disease and other conditions that lead to heart attacks. Better MRI methods are needed to improve heart disease diagnosis, especially by avoiding the use of radiation. Researchers are testing new techniques to improve the quality of heart MRI, compared with more complex studies like catheterization or angiography.\n\nObjectives:\n\n\\- To compare heart MRI techniques with other tests used to diagnose heart disease.\n\nEligibility:\n\n\\- People at least 18 years of age who either have or may have heart disease, or are healthy volunteers.\n\nDesign:\n\n* Participants will be screened with a physical exam, medical history, and blood tests.\n* They will have an angiography to study the inside of blood vessels. This test is an x-ray study of the blood vessels. It will be done either separately or as part of a set of tests to diagnose possible heart disease.\n* Participants will have at least one and up to five MRI scans. The scans will involve different methods of studying the heart and blood vessels. Participants may also have a computed tomography scan to confirm the findings of an MRI scan.\n* No treatment will be provided as part of this protocol.",[568,25,26,305,569],"Healthy","Atherosclerosis",[571,572,573,574,575,307,280,576,64,577],"Distensibility Imaging","Arteriosclerosis, Narrowing of Vessels","Endothelial Dysfunction","Hardening of the arteries","Non-Invasive Plaque Imaging","Arteriosclerosis","HV","2026-08-01",{"date":580,"type":36},"2026-08-04",{"date":582,"type":36},"2011-07-06",{"date":584,"type":21},"2030-11-05",{"name":42,"class":43},{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":16,"minAge":256,"maxAge":169,"enrollmentInfo":594,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":596,"conditions":597,"keywords":603,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":44},"100650590","improving-patient-centered-care-for-underserved-older-african-american-patients-with-cardiovascular-comorbidities-100650590","NCT07748858","Improving Patient-Centered Care for Underserved Older African American Patients With Cardiovascular Comorbidities","Improving Patient-Centered Care for Underserved Older African American Patients With Cardiovascular Comorbidities: A Pilot Study of the Patient Priorities Care Approach at Cooper Green Mercy Health Services Authority (PPC-HEART)","PPC Heart","Inclusion Criteria:\n\n* greater than or equal to 50 years old\n* at least one CVD (i.e., coronary artery disease, hypertension, heart failure, arrhythmias, cardiomyopathy, peripheral artery disease, stroke, and valvular heart disease)\n* at least one coexisting chronic condition (i.e., inflammatory joint disease, COPD\u002Fasthma, diabetes, chronic kidney disease, and cancer one-year post-treatment)\n* a caregiver of a participant, or a provider who serves this population.\n\nExclusion Criteria:\n\n* Axis I psychiatric (schizophrenia, bipolar disorder), dementia, suicidal ideation,\n* active substance use disorder nursing home or assisted living facility residence.",{"count":595,"type":21},29,"This is formative evaluation trial guided by the Values Clarification Theory25 and the Cultural Values Theory26, with specific aims to: Aim 1. Develop a culturally appropriate version of the PPC Approach for older AAs with CVCs by assembling a community advisory group of 3 primary care clinicians, 3 older AA patients with CVCs, and 3 AA persons who care for AA patients with CVCs to solicit feedback on the PPC Approach. Aim 2. Determine the acceptability (e.g., program appraisal interviews) and feasibility (e.g., avg. length of program sessions, program participation rate, study completion rate) of the PPC Approach among a sample 20 of under-resourced older southern AA patients with CVCs receiving primary care at Cooper Green Mercy Health Services Authority. Aim 3. Examine the ability of participants to complete pre- and post-test (8 weeks post-baseline) measures of perception of care, treatment burden, shared decision-making, and patient-clinician communication exchange.",[598,599,26,600,601,602,307],"Cardiovascular","Comorbidity","Inflammatory Joint Diseases","Chronic Kidney Diease","Chronic Obstructive Pulmonary Disease (COPD)",[262,175,604,605,606,607,608,609],"Chronic Obstructive Pulmonary Disease","Patient-Centered Care","Shared Decision Making","Care Coordination","Older Adults","Multiple Chronic Conditions","2026-07-31",{"date":382,"type":36},{"date":613,"type":36},"2026-05-01",{"date":615,"type":21},"2027-06",{"name":617,"class":132},"University of Alabama at Birmingham",{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":16,"minAge":168,"maxAge":4,"enrollmentInfo":624,"targetDuration":626,"studyType":22,"phases":4,"briefSummary":627,"conditions":628,"keywords":630,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":641},"100617321","omnipod-5-a-french-prospective-multicentric-study-in-real-world-optimal-b-100617321","NCT07317102","Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)","Inclusion Criteria:\n\n* Patient with T1D aged ≥ 2 years.\n* Patient prescribed, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor.\n* Patient has never used the Omnipod 5 System prior to inclusion.\n* Patient has not objected to the use of their personal data for this study.\n* Patient or legal guardian has an email address and mobile phone number.\n* Patient (and legal guardians if the patient is a minor) is able to understand study information and Non-Opposition form.\n* Patient (and legal guardians if the patient is a minor) is able to understand and complete questionnaires in French.\n* Patient is covered by the local social security system\n\nExclusion Criteria:\n\n* Patient is currently pregnant.\n* Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM).\n* Patient is unable to be followed by the same investigation site for the duration of the study or is unwilling or unable to maintain contact with the healthcare professional.\n* Patient is already participating in a clinical trial or in another study precluding their participation in other studies.\n* Adult under guardianship, curatorship or tutorship.\n* Adult otherwise deprived of liberty.",{"count":625,"type":21},152,"12 Months","The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.",[26,629,488],"Type 1 Diabetes",[631,632,633],"Omnipod","Automated Insulin Delivery","Post-market Registry",{"date":512,"type":36},{"date":636,"type":36},"2026-03-16",{"date":638,"type":21},"2027-11",{"name":640,"class":248},"Insulet Corporation",24,{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":646,"acronym":647,"eligibilityCriteria":648,"healthyVolunteers":84,"sex":16,"minAge":52,"maxAge":319,"enrollmentInfo":649,"targetDuration":4,"studyType":56,"phases":651,"briefSummary":653,"conditions":654,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":4},"100565714","early-phase-1-na-phenylbutyrate-vascular-trial-100565714","NCT06645769","Na-Phenylbutyrate VAscular Trial","NAPVAT","Inclusion Criteria:\n\n* Over 18 years of age and less than 60.\n* Healthy subjects will have no history of diabetes or prediabetes.\n* Diabetes subjects can be either insulin dependent or not.\n* Able to provide written consent and to comply with the procedures of the study protocol.\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>60\n* Pregnant or lactating women.\n* Subjects with hypertension or taking any vasodilatory medications, any steroidal drugs, haloperidol, or valproic acid.\n* Patients with congestive heart failure, severe renal insufficiency, hepatic failure, or known sodium retention with oedema.\n* Active alcohol or substance abuse.\n* Use of tobacco within the previous six months.\n* Unble to provide written consent and to comply with the procedures of the study protocol.",{"count":650,"type":21},30,[652],"EARLY_PHASE1","This study will investigate if the drug sodium phenylbutyrate (NaPB) impacts blood pressure and vascular function in healthy volunteers and in patients with diabetes.",[26],"2026-07-27",{"date":657,"type":36},"2026-07-28",{"date":659,"type":21},"2027-06-01",{"date":661,"type":21},"2029-06-01",{"name":663,"class":132},"University of Pennsylvania"]