[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":467},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,67,0,25,[9,44,69,93,113,135,163,185,208,229,253,273,286,295,304,313,323,332,342,367,376,385,395,417,443],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053383","assessing-the-impact-of-perceptions-of-unpredictability-on-objective-measures-of-food-consumption-and-metabolism-100053383",false,"NCT06690294","Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism","Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism: A Natural History Study","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* 18-60 years of age.\n* Able to read and understand English proficiently (to be able to complete the multiple study questionnaires and instruments).\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Diabetes\n\n  * Fasting glucose \\>= 126 mg\u002Fdl or HbA1c \\>= 6.5% or\n  * Self-reported history of type 1 or type 2 diabetes.\n* Endocrine disorders, such as\n\n  --Self-reported history of Cushing's disease, pituitary disorders, or hypo- and hyperthyroidism\n* TSH \\\u003C0.1 or \\>= 10 uIU\u002FmL\n* Pulmonary disorders\n\n  --Self-reported history of chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol (investigator judgment)\n* Cardiovascular diseases,\n\n  --Self-reported history of coronary heart disease, heart failure, arrhythmias, and peripheral artery disease that which would limit ability to follow the protocol (investigator judgment)\n* Liver disease,\n\n  * Advanced liver disease (as determined by history, labs, exams, and patient self-report) that which would limit ability to follow the protocol (investigator judgment)\n  * AST or ALT elevations \\> 3 times upper limit of normal\n* Gastrointestinal Surgery\n\n  --Self-reported history of bariatric surgery\n* Renal disease\n\n  * Self-reported history of renal replacement therapy\n  * Abnormal kidney function (defined as eGFR \\\u003C60 mL\u002Fmin\u002F1.73m\\^2) determined at screening (eGFR values are computed using the 2021 CKD-epi equation)\n* Central nervous system disease:\n\n  --Including self-reported history of previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders\n* Infectious disease:\n\n  --Self-reported history of active tuberculosis, HIV, chronic coccidiomycosis or other chronic or acute infections\n* For Females: pregnancy, \\\u003C=6 months postpartum, currently breastfeeding, or on birth control (i.e., ingested, injected or implanted; non-hormonal methods such as copper IUD will be allowed)\n* Measured weight: greater than or equal to 450 lb. (maximum weight allowed on the DXA scanning tables by the manufacturer)\n* Inability to provide informed consent.\n* Self-reported history of psychological conditions including (but not limited to), active psychosis, schizophrenia, eating disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study.\n* Current use of medications\u002Fdietary supplements\u002Falternative therapies known to alter energy metabolism.\n* Inability to consume provided food during ad libitum food intake or snack food test based on a food allergy or intolerances or diet restrictions.\n* Any disorder not covered by any other exclusion criteria which, in the investigator's and\u002For team's opinion jeopardizes the safety of the participant or others or would interfere with adherence to the protocol.\n* Alcohol Abuse as defined by \\>= 8-point score on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire will be an exclusion criterion.\n* Current use of tobacco products that exceed \"Very Low Dependence\" on the Fagerstrom Test for Nicotine Dependence Tool (score greater than 2) will be an exclusion criterion.\n\nNon-English-speaking subjects as a population will be excluded from participation in this protocol. Primary and secondary hypotheses of the protocol relate to a battery of psychological questionnaires and performances tests which are administered throughout the study. There are currently no validated, translated forms of these questionnaires and tests available; therefore, we will restrict enrollment to English speaking subjects only.","ALL","18 Years","60 Years",{"count":21,"type":22},110,"ESTIMATED","OBSERVATIONAL","Background:\n\nMany people in the United States are overweight or obese. This natural history study will look into how life events during childhood can impact eating behaviors and weight gain as adults.\n\nObjective:\n\nTo explore how childhood experiences affect adult eating behaviors.\n\nEligibility:\n\nHealthy people aged 18 to 60 years.\n\nDesign:\n\nParticipants will have 3 clinic visits.\n\nThey will be screened with blood tests. They will answer questions about their alcohol and tobacco use.\n\nAt the next visit, participants will undergo these activities:\n\nParts of their body (such as waist, neck, and thighs) will be measured with a tape.\n\nThey will have an imaging scan to find out how much body fat they have.\n\nThey will start wearing a device like a wristwatch that measures their physical activity. They will wear this device for up to 10 days.\n\nThey will wear a device on their upper arm or belly that measures blood glucose (sugar) levels. Participants will wear this for 7-10 days.\n\nThey will answer questions about their education, childhood, and routines.\n\nThey will receive a kit to collect a stool sample at home.\n\nAt the last visit, participants will have these tests:\n\nParticipants will relax and breathe normally while wearing a clear, plastic canopy that fits over their entire head.\n\nBlood samples will be taken before and after participants drink a sugary drink.\n\nParticipants will be offered a large selection of foods for lunch. They will eat as much as they want. Then they will answer questions about how they feel about food and themselves.",[26,27],"Healthy Volunteer","Obestity",[26,29,30],"Obesity","Eating Behavior","NOT_YET_RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":22},"2026-07-16",{"date":39,"type":22},"2027-01-30",{"name":41,"class":42},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":66,"leadSponsor":68,"locationsCount":43},"100053534","phase-1-ketoconazole-effects-on-the-daily-cortisol-rhythm-in-mild-autonomous-cortisol-secretion-100053534","NCT07649317","Ketoconazole Effects on the Daily Cortisol Rhythm in Mild Autonomous Cortisol Secretion","Ketoconazole Effects on Cortisol Circadian Rhythm in Mild Autonomous Cortisol Secretion: A Pilot Study","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Aged 18 years or older.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Agreement to adhere to Lifestyle Considerations throughout the study.\n\nA. Subjects with Mild Autonomous Cortisol Secretion (MACS):\n\n1. Co-enrollment in protocol 19DK0066.\n2. Abnormal low-dose overnight dexamethasone suppression test (morning serum cortisol \\>1.8 mcg\u002FdL following 1 mg oral dexamethasone between 2300-0000h the evening prior)\n3. One or more \\>=1 cm adrenal nodule(s) on one or both adrenal glands on CT or MRI\n4. One normal 24-hour urine free cortisol value (per the reference range of the assay used).\n5. One morning plasma ACTH value \\\u003C10 pg\u002FmL.\n\nB. Healthy volunteers:\n\n1. In good general health as evidenced by medical history and physical examination; and in a stable state of health without ongoing acute\u002Ftemporary illness per the clinical judgment of the investigator.\n2. Normal low-dose overnight dexamethasone suppression test (morning serum cortisol \\\u003C=1.8 mcg\u002FdL following 1 mg oral dexamethasone between 2300-0000h the evening prior)\n3. Matching a participant with MACS who has completed testing in regard to:\n\n   * Age: Birth year within 5 years of that of the participant with MACS.\n   * Sex\n   * BMI (kg\u002Fm2) category: \\\u003C18.5 (underweight); 18.5-24.9 (normal weight); 25-29.9 (overweight); 30-34.9 (obesity class 1); 35-39.9 (obesity class 2); \\>=40 (obesity class 3).\n   * For women: menopausal status as judged by absence of menses for one year and FSH\\>15 mIU\u002FmL.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Inability to comply with all study procedures and visits.\n2. Inability of subject to understand or to sign a written informed consent document.\n3. Pregnancy or breastfeeding.\n4. Use of estrogen-containing oral contraceptives or oral estrogen therapy within 6 weeks before inpatient admission, due to possible increases in serum corticosteroid-binding globulin, and thereby total cortisol.\n5. Use of medications within 2 weeks before inpatient admission that can block glucocorticoid production or action: ketoconazole (systemic), levoketoconazole, metyrapone, osilodrostat, mifepristone.\n6. Use of oral, injectable, or inhaled glucocorticoids (unless intermittent, for symptomatic asthma) within the year before inpatient admission. Use of topical non-hydrocortisone containing potent glucocorticoids on more than 36 square inches within six months before inpatient admission.\n7. Anemia (hemoglobin \\\u003C13.7 g\u002FdL for males, \\\u003C11.2 g\u002FdL for females).\n8. Daily alcohol risk use (\\>2 standard drinks per day by self-report during screening visit).\n9. Severely uncontrolled diabetes mellitus (HbA1c \\>9.0%).\n10. Highly irregular sleep schedule in the week leading up to inpatient admission (e.g. shift work).\n11. Any contraindication to intravenous catheter use.\n12. Previous participation in this protocol.\n13. Any condition that in the opinion of the Investigator would jeopardize the participant s appropriate participation in this study.\n14. Any hematology or chemistry screening laboratory value drawn at screening that the Investigator deems clinically significant for exclusion.\n\nA. Subjects with Mild Autonomous Cortisol Secretion (MACS):\n\n1. Evidence of hyperaldosteronism, which must have been ruled out with serum aldosterone and plasma renin activity measurements if the participant has a history of hypertension or hypokalemia, per standard clinical care.\n2. Evidence of pheochromocytoma, which must have been ruled out with plasma or 24-hour urine metanephrines if an unenhanced adrenal nodule is \\>10 HU, per standard clinical care.\n3. Known allergy or hypersensitivity to ketoconazole.\n4. Significant liver disease or alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\>3xULN, and\u002For total bilirubin \\>1.5xULN during Screening.\n5. Prolonged QTc interval (\\>500 msec) on screening ECG.\n6. Use of medications in the 2 weeks before inpatient admission that can:\n\n   * Prolong QT when combined with ketoconazole (KTZ):\n\n     \\-- dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, ranolazine.\n   * Cause toxicity from increased concentration due to KTZ-induced CYP3A4 inhibition:\n\n     --methadone, disopyramide, dronedarone, ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine, methylergometrine, irinotecan, lurasidone, oral midazolam, alprazolam, triazolam, felodipine, nisoldipine, ranolazine, tolvaptan, eplerenone, lovastatin, simvastatin and colchicine.\n   * Inhibit CYP3A4 and increase KTZ bioavailability:\n\n     \\-- ritonavir, darunavir, fosamprenavir.\n   * Induce CYP3A4 and decrease KTZ bioavailability:\n\n     * Isoniazid, rifabutin, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine.\n7. Inability to pause, for 24 hours, use of medication that reduces KTZ absorption: proton pump inhibitors (dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole) and H2 antagonists (cimetidine, famotidine, nizatidine).\n\nInability to pause, for 3 hours, use of short-acting acid neutralizers that reduce KTZ absorption, e.g. aluminum hydroxide (acceptable if taken \\>=1 hour before or \\>=2 hours after KTZ).","100 Years",{"count":53,"type":22},36,"INTERVENTIONAL",[56],"PHASE1","Background:\n\nCortisol is a hormone in the blood. Cortisol levels normally go down at night and up in the morning. Mild autonomous cortisol secretion (MACS) is a disease in which the body makes too much cortisol. MACS can cause high blood pressure, diabetes, and\u002For weight gain. Researchers think these problems may be caused by higher cortisol levels at night.\n\nObjective:\n\nTo compare daily cortisol levels in people with MACS with those in healthy people. Also, to test a drug (ketoconazole) that may help lower cortisol levels in people with MACS.\n\nEligibility:\n\nPeople aged 18 years and older with MACS. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants with MACS will have a 2-night stay in the hospital.\n\nDay 1: A thin tube called a catheter will be inserted into a vein in the arm. Blood will be collected through the catheter every 2 hours starting at 8 PM. Participants will begin a 24-hour urine collection. Saliva will be collected every 6 hours for 24 hours.\n\nDay 2: Participants will take 2 tablets of the study drug ketoconazole with their evening meal. Blood will be collected via the catheter at regular intervals throughout the night.\n\nDay 3: Participants will leave the hospital in the morning.\n\nHealthy volunteers will be screened with a physical exam and blood tests. They will be tested to make sure they do not have MACS. To do this, they will take a drug (dexamethasone) at 11 PM on a day they choose; then they will return the next morning for a blood test.\n\nHealthy volunteers will have a 1-night stay in the hospital. They will have blood, urine, and saliva collected for 24 hours.",[59],"Mild Autonomous Cortisol Secretion",[61,62,59],"Cortisol","KETOCONAZOLE","RECRUITING",{"date":34,"type":35},{"date":37,"type":22},{"date":67,"type":22},"2027-12-31",{"name":41,"class":42},{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":17,"minAge":18,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":54,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":43},"100053438","phase-2-trial-of-the-combination-of-alpha-lipoic-acid-and-mirabegron-in-women-and-in-men-with-obesity-100053438","NCT05713799","Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity","Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity","* INCLUSION CRITERIA\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Adults 18 to 65 years of age\n2. BMI greater than or equal to 30 kg\u002Fm\\^2 and less than or equal to 45 kg\u002Fm\\^2\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Hypersensitivity and associated allergic reactions to mirabegron or alpha-lipoic acid (or similar drug substances or components).\n2. Abnormal bladder function, diagnosis of bladder outlet obstruction, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB).\n3. Type 1 diabetes mellitus; type 2 diabetes mellitus; or any person taking exogenous insulin therapy or any medication that is a hypoglycemic agent. (type 1 or Type 2 Diabetes mellitus, fasting serum glucose \\>125 mg\u002FdL, and\u002For an HbA1c test \\>6.5%).\n4. Elevated resting blood pressure \\>140\u002F90 mmHg.\n5. Individuals with eGFR \\\u003C60 ml\u002Fmin\u002F1.72 m\\^2 and a urinary albumin\u002Fcreatinine ratio UACR\\>300 mg\u002Fg.\n6. Hypo- or hyper-thyroid disease (TSH \\>5.0, or \\\u003C0.4 MIU\u002FL) that is controlled for less than one year or someone currently taking thyroid hormone replacement.\n7. Anemia, defined by hemoglobin \\\u003C11.5 g\u002FdL (females) or \\\u003C13.5 g\u002FdL (males); sickle cell anemia or other blood disorders; and\u002For wound healing problems.\n8. Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment.\n9. A clinically significant abnormal ECG and\u002For QTc interval above normal\n10. Moderate hepatic impairment (Child-Pugh Class B) or above\n11. Elevated liver enzymes \\>75 U\u002FL (ALT or AST)\n12. Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics\n13. Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months.\n14. Individuals that have been on a very low-calorie diet (\\\u003C800 kcal\u002Fd), self-reported weight loss \\>5% in the preceding six months, or those taking weight loss medications.\n15. History of seizure disorder.\n16. Addiction to alcohol or substances of abuse within the last 5 years.\n17. Self-reported current alcohol consumption of more than 2 servings of alcohol per day.\n18. Self-reported current use of nicotine and\u002For tobacco products.\n19. Current use of any drugs known to:\n\n    1. Have major drug-drug interactions with mirabegron or alpha-lipoic acid\n    2. Be CYP2D6 substrates\n    3. Prolong QT interval\n    4. Alter glucose metabolism or cause insulin resistance (in last six months)\n    5. Treat diabetes mellitus\n    6. Treat hypertension\n    7. Be drugs of abuse\n20. Inability to provide informed consent.\n21. Unwilling or unable to eat metabolic meals, as determined by dietitian consult.\n22. Individuals with significant medical comorbidities or other factors that would render the individual s participation unsafe or affect the outcome of the study as assessed by the investigator.",true,"65 Years",{"count":79,"type":22},60,[81],"PHASE2","Background:\n\nObesity and related illnesses cause at least 2.8 million deaths each year worldwide. Few treatments exist for obesity that are safe and widely available. A study drug (mirabegron \\[MG\\]) combined with a supplement (alpha-lipoic acid \\[ALA\\]) may help.\n\nObjective:\n\nTo learn how MG and ALA can help the body process food.\n\nEligibility:\n\nPeople aged 18 to 65 years with a body mass index between 30 and 45 kg\u002Fm2.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam. They will have blood and urine tests and a test of their heart function. They will speak with a dietician.\n\nThe study has two phases. Each phase begins with a 2-day stay in the clinic; then the participant will take the study drugs at home for about 4 weeks, followed by another 2-day stay in the clinic. They will also have outpatient visits about 2 weeks after each clinic stay.\n\nDuring the clinic stays, participants will undergo many tests:\n\nThey will have a plastic tube (catheter) inserted into a vein in each arm. These will be used to draw blood and to infuse glucose (sugar) and insulin.\n\nThey will have imaging scans.\n\nThey will have a clear hard plastic shield placed over their head to measure oxygen and carbon dioxide as they breathe.\n\nParticipants will take the study drugs at home. Both MG and ALA are taken by mouth with water. During one phase, participants will take MG plus a placebo. A placebo looks like the study drug but doesn t contain medicine....",[84,29],"Insulin Resistance",[29,86,84,87],"Insulin Sensitivity","Placebo",{"date":34,"type":35},{"date":37,"type":22},{"date":91,"type":22},"2030-03-01",{"name":41,"class":42},{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":110,"leadSponsor":112,"locationsCount":43},"100053269","hepatic-lipid-metabolism-alcohol-use-disorder-100053269","NCT07191561","Hepatic Lipid Metabolism-Alcohol Use Disorder","Mechanisms in Hepatic Lipid Metabolism in Alcohol Use Disorder: From Genomics, Transcriptomics to Metabolomics","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Any individual \\>=18 years of age who is enrolled in 14-AA-0181 and is seeking inpatient treatment.\n* Vibration Controlled Elastography parameters with initial CAP of \\>295dB\u002Fm.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnancy\n* Existing diagnosis of hyperlipidemia or essential hypertension\n* Hemoglobin A1c \\>= 6.5%\n* Waist to hip ratio: \\>=0.90 in males, \\>=0.85 in females\n* Existing use of cholesterol lowering medications including statins, fibrates, or other similar medications used for the purposes of treating hyperlipidemia.\n* Those with evidence of severe alcoholic hepatitis with a Maddrey s Discriminant Function \\> 32\n* Those with other chronic liver diseases including chronic hepatitis B (positive hepatitis B surface Ag on admission), hepatitis C (positive hepatitis C RNA), or autoimmune hepatitis (clinical diagnosis based on high titer of positive ANA and or anti smooth muscle Ab and a history of autoimmune disease)\n* HIV infection\n* Contraindication or inability to perform a liver biopsy.\n\n  * Participants with coagulopathy (PT\u002FPTT values that are prolonged (Bullet) 3 seconds from the upper limit of the normal, including treatment with oral and parenteral anticoagulants), thrombocytopenia (\\\u003C 70,000), abnormal bleeding time or platelet dysfunction. Antiplatelet agents taken for cardiovascular prevention will not exclude participants, unless they cannot be stopped safely for the performance of a liver biopsy.\n  * Hemoglobin level \\\u003C 11 g\u002FdL\n  * Inability to provide informed consent.",{"count":7,"type":22},"Patients with hepatic steatosis due to alcohol will be offered liver biopsies when they enter a detoxification program. The first biopsy will occur in the first week of admission and the second in the fourth week when the steatosis has resolved. The hepatic transcriptome will be compared,",[103],"Alcohol Use Disorder",[105,106,107],"Alcohol","Liver","Biopsy",{"date":34,"type":35},{"date":37,"type":22},{"date":111,"type":22},"2029-11-30",{"name":41,"class":42},{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":17,"minAge":119,"maxAge":77,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":132,"leadSponsor":134,"locationsCount":43},"100053739","evaluation-of-the-clinical-spectrum-of-diabetes-and-obesity-in-youth-and-adults-100053739","NCT07388537","Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age 8 years to 65 years\n2. Meet at least one of the following:\n\n   a. Overweight\u002FObesity:\n\n   i. For participants under 18 years of age: BMI \\>= 85th percentile for age and sex\n\nii. For participants \\>= 18 years of age: BMI \\>= 25 kg\u002Fm\\^2 (\\>=23 kg\u002Fm\\^2 for self-reported Asian race\u002Fethnicity)\n\nb. Suspected or evidence of hyperglycemia:\n\ni. Diagnosis of prediabetes or diabetes in medical history or by participant\u002Fguardian\u002FLegally Authorized Representative (LAR) report, OR\n\nii. Fasting blood glucose \\>= 100 mg\u002FdL in medical record, OR\n\niii. Postprandial blood sugar \\>= 140 mg\u002FdL in medical record, OR\n\niv. Hemoglobin A1c \\>= 5.7% in medical record\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History of significant medical illnesses that the investigators feel may interfere with potential evaluations, i.e. individuals who are critically ill, unstable, or with severe organ failure that may affect\u002Flimit the endocrine evaluation and place unsustainable demands on Clinical Center or NIDDK resources.\n2. History of any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the participant.\n3. Inability or unwillingness of participant, parent\u002Fguardian, or LAR to provide informed consent.","8 Years",{"count":121,"type":22},1000,"Background:\n\nDiabetes and obesity are chronic diseases. They can affect blood flow and how the body processes nutrients, and complications over time can lead to early death. Diabetes can affect children as well as adults, but the disease seems to be more severe and to progress faster when it appears in younger people. Researchers want to understand more about how diabetes and obesity develop and change over time.\n\nObjective:\n\nTo collect data and samples regularly from people with obesity and diabetes.\n\nEligibility:\n\nPeople aged 8 to 65 years. They must be overweight or obese; or have high blood sugar; or have problems with how their body uses food for energy.\n\nDesign:\n\nParticipants will have additional procedures during routine care visits at the NIH clinic.\n\nData collected for the study will include the following:\n\nInformation from the participant s medical chart will be kept for research.\n\nQuestionnaires will ask about participant s eating habits, feelings, sleep, and substance use. They will take 30 to 60 minutes. Care providers will address any issues revealed in these surveys.\n\nBlood, saliva, urine, and stool samples will be collected. Samples may be used for genetic tests.\n\nData and samples will be kept for future research.\n\nParticipants may remain in the study up to 30 years.",[29,124,125],"Diabetes","Metabolic Disorders",[127,29,128,129],"Clinical Spectrum of Diabetes","Hyperglycemia","Metabolic Disease",{"date":34,"type":35},{"date":37,"type":22},{"date":133,"type":22},"2055-04-30",{"name":41,"class":42},{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":54,"phases":145,"briefSummary":146,"conditions":147,"keywords":152,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":160,"leadSponsor":162,"locationsCount":43},"100054144","phase-2-effects-of-meal-macronutrients-on-postprandial-lipids-100054144","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\n1. BMI \\>30 kg\u002Fm\\^2 (or \\>=27 kg\u002Fm\\^2 in participants of Asian descent), OR\n2. 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\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       2\\. Elevated triglycerides defined as EITHER\n\n       2a. Fasting triglycerides \\>= 150 mg\u002FdL at screening, OR\n\n       2b. Specific treatment for hypertriglyceridemia\n\n       3\\. Low HDL cholesterol, defined as EITHER\n\n       3a. HDL \\\u003C40 mg\u002FdL (males) or \\\u003C50 mg\u002FdL (females) at screening, OR\n\n       3b. Specific treatment for low HDL\n\n       4\\. Elevated blood pressure defined as EITHER\n\n       4a. Systolic BP \\>= 130 at screening, OR\n\n       4b. Diastolic BP \\>= 85 mm Hg at screening, OR\n\n       4c. Treatment of previously diagnosed hypertension\n\n       5\\. Elevated glucose defined as EITHER\n\n       5a. HbA1c \\>= 5.7% (at screening), OR\n\n       5b. Fasting serum glucose \\>= 100 mg\u002FdL (at screening), OR\n\n       5c. 2-hour post-load glucose levels \\>= 140 mg\u002FdL (by history), OR\n\n       5d. Prior diagnosis of type 2 diabetes\n\n   Lipodystrophy-specific inclusion criteria:\n   1. 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 aminimum, the gluteofemoral depot).\n   2. 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\n   Nephrotic syndrome specific inclusion criteria\n   1. History of biopsy proven non-diabetic glomerular disease (any histology)\n   2. Nephrotic range proteinuria defined by ANY of the following:\n\n   2a. Protein\u002Fcreatinine ratio uPCR \\>= 3.5 g\u002Fg at screening, OR\n\n   2b. 24 hour protein excretion \\>= 3.5 gr\u002F24hr) at screening, OR\n\n   2c. 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\n   EXCLUSION CRITERIA:\n\n   Common exclusion criteria (all groups):\n\n   An individual who meets any of the following criteria will be excluded from participation in this study:\n   1. Consuming extreme macronutrient diet (e.g., very low-carbohydrate, high fat diets such as ketogenic, paleo or Atkins diets, among others).\n   2. 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).\n   3. 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.\n   4. Body weight \\>450 lbs (upper limit that can be accommodated by DXA scanner).\n   5. 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.\n   6. Uncontrolled diabetes, defined as HbA1c \\>9% at screening.\n   7. Lipemia defined as fasting or non-fasting triglycerides of \\>1000 mg\u002FdL at screening.\n   8. Renal dysfunction defined as eGFR \\\u003C50 mL\u002Fmin\u002F1.73 m\\^2 at screening.\n   9. 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.\n   10. History of hypertriglyceridemia-induced pancreatitis within 3 months prior to screening.\n   11. Positive pregnancy test or breastfeeding at screening.\n   12. Clinically significant abnormalities in thyroid function, blood counts, as assessed by screening labs.\n   13. Acute cardiovascular events within the past 6 months\n   14. Anemia (Hgb \\\u003C10 mg\u002FdL in women or \\\u003C12 mg\u002FdL in men) at screening\n   15. 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).\n   16. Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.\n   17. Subjects treated with tamoxifen, estrogens, or progestins that have not been stable for \\>4 weeks prior to screening.\n   18. Blood donation in the last 2 weeks or planned blood donation during the study\n   19. Subjects requiring regular transfusions for any reason.\n   20. Subjects with known gastroparesis\n   21. Inability to adhere to Lifestyle Considerations throughout study duration.\n   22. Inability of the subject to understand and the unwillingness to sign a written informed consent document.\n   23. Unwillingness to comply with all study procedures and unavailable for the duration of the study\n   24. Any other condition or medication which, in the opinion of the investigator, increases risk to the subject, prevents the subject from complying with study procedures, prevents the subject from completing the study, or interferes with the interpretation of study results.","120 Years",{"count":144,"type":22},100,[81],"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....",[148,149,150,26,124,151],"Nephrotic Syndrome","Lipodystrophy","Metabolic Syndrome","Metabolic Associated Steatotic Liver Disease",[153,154,155,156,157],"postprandial lipids","macronutrient","CARBOHYDRATES","FATS","Proteins",{"date":34,"type":35},{"date":37,"type":22},{"date":161,"type":22},"2031-08-01",{"name":41,"class":42},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":171,"conditions":172,"keywords":176,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":182,"leadSponsor":184,"locationsCount":43},"100053628","longitudinal-immunophenotyping-of-patients-with-inflammatory-bowel-disease-100053628","NCT07619547","Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nAffected Participant cohort:\n\n1. Adults 18 - 85 years of age\n2. History of:\n\n   1. a verifiable diagnosis of Crohn's disease, ulcerative colitis, or IBD known to be associated with a co-existing condition (such as CTLA4 deficiency or common variable immune deficiency) and which is supported by characteristic clinical features, radiographic or endoscopic findings, or consistent histopathologic mucosal changes related to chronic inflammation; and\u002For\n   2. a defined genetic syndrome\u002Fmutation linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD\n3. Presence of a referring community physician who would be able to manage care outside of NIH\n\nUnaffected family member of participant:\n\nImmediate relative to the enrolled participant (mother, father, sibling, or adult child) may be recruited and enrolled to improve interpretation of genetic results or expand the phenotype of the IBD\n\n1. Adults 18 - 99 years of age\n2. In good general health\n3. No medical diagnosis of IBD\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Unable or unwilling to provide informed consent\n2. Evidence of significant medical illnesses that the investigators feel may interfere with study evaluations and procedures","85 Years",{"count":144,"type":22},"Background:\n\nInflammatory bowel disease (IBD) is a term used to describe disorders that cause long-term inflammation in the digestive tract. Symptoms include stomach pain, diarrhea, and bleeding. Crohn's disease and ulcerative colitis are the 2 main types of IBD. Researchers want to conduct a natural history study to learn more about whether genetic factors can cause IBD; how immune cells contribute to IBD; and how diet, drugs, and disease affect those cells.\n\nObjective:\n\nTo better understand IBD over time.\n\nEligibility:\n\nAdults aged 18 to 85 years with Crohn's disease, ulcerative colitis, or another IBD. Their healthy relatives are also needed.\n\nDesign:\n\nAffected participants will have clinic visits every 6 months for 3 years.\n\nOnce a year, they will have these procedures:\n\nA physical exam with blood and stool samples.\n\nUltrasound of the abdomen. A wand will be rolled over the skin. It uses sound waves to capture images of the intestines.\n\nMagnetic resonance imaging (MRI) scan. They will lie on a table that slides into a tube. Magnetic fields will capture images of the intestines.\n\nColonoscopy. A long, flexible tube with a video camera will be inserted into the rectum to view the entire colon. Up to 12 tissue samples may be taken.\n\nUpper endoscopy, for those with Crohn's disease. A long, thin tube with a camera will be inserted through the mouth and into the first part of the small intestine. Up to 12 small tissue samples may be taken.\n\nQuestionnaires. Participants will answer questions about their disease and their diet.\n\nMidyear visits will include a physical exam, blood and stool collection, ultrasound, and questionnaires\n\nHealthy relatives will have 1 blood draw for genetic tests.",[173,174,175],"Inflammatory Bowel Disease","Crohn's Disease","Ulcerative Colitis",[177,178,179],"Immune System","Inflammation","gastroenterology",{"date":34,"type":35},{"date":37,"type":22},{"date":183,"type":22},"2036-06-01",{"name":41,"class":42},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":192,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":205,"leadSponsor":207,"locationsCount":43},"100054296","prevalence-and-development-of-liver-dysfunction-in-hematopoietic-stem-cell-transplant-100054296","NCT05722210","Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant","Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant: A Prospective Natural History Study","* INCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be included in this study:\n\n* Male and female adults \\>=18 years of age and children 3-17 years of age\n* Undergoing evaluation for hematopoietic stem cell transplant at the NIH Clinical Center\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this\n\nstudy:\n\n* Pregnancy or lactation\n* Unable to comply with study procedures\n* Inability to provide written informed consent","3 Years","90 Years",{"count":195,"type":22},500,"Background:\n\nHematopoietic stem cell transplant (HSCT) is a common treatment for many cancers and other illnesses. But many people who have HSCT go on to develop liver dysfunction. Researchers want to know more about how and why this happens. In this natural history study, they will try to learn what factors lead to liver dysfunction; how underlying liver disease may affect the results of HSCT; and how HSCT may contribute to liver dysfunction.\n\nObjective:\n\nTo understand the links between HSCT and liver dysfunction.\n\nEligibility:\n\nAdults aged 18 years or older and children 3 to 17 years who are being evaluated for HSCT.\n\nDesign:\n\nThis study involves 11 visits in 4 years. Most visits will be in the first year.\n\nBefore and after their HSCT, participants will undergo these tests:\n\nPhysical exam, including blood tests and a test of heart function. Participants will provide stool samples.\n\nLiver biopsies. Samples of liver tissue will be removed. This may be done either by inserting a needle through the right side of the chest, or with a thin tube threaded to the liver from a vein in the neck. Adult participants will undergo this procedure 2 times: once before the HSCT and once about a year later.\n\nImaging scans. Participants will lie on a bed that moves into either a cylinder or a donut-shaped machine.\n\nUltrasound. Participants will lie still. A probe that uses sound waves will be slid over their skin to get pictures of the liver.\n\nFibroscan exam. This is like an ultrasound that uses a special probe to measure the toughness of the liver.\n\n...",[198],"Hematopoietic Stem Cell Transplant",[200,201,202],"Liver Disease","Liver Dysfunction","Natural History",{"date":34,"type":35},{"date":37,"type":22},{"date":206,"type":22},"2031-06-30",{"name":41,"class":42},{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":215,"targetDuration":4,"studyType":54,"phases":217,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":226,"leadSponsor":228,"locationsCount":43},"100054224","phase-1-177lu-dota-eb-tate-in-adult-patients-with-metastatic-radioactive-iodine-non-responsive-oncocytic-hurthle-cell-thyroid-cancer-100054224","NCT06991738","177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer","Phase 1\u002F2, Open-Label Study of the Safety, Dosimetry and Efficacy of a 3-Dose Regimen of Escalating Doses of 177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Aged 18 years or older.\n* Metastatic RAI-non-responsive and\u002For RAI-non-avid oncocytic (Hurthle cell) thyroid cancer.\n* Progressive disease by RECIST 1.1 criteria, with or without symptoms within the last 12 months. This applies to patients with non-measurable disease by RECIST 1.1 criteria, who will be eligible if they have evidence of progression as defined by the development of new lesions within the last 12 months.\n* High expression of SSTR2 in at least one metastatic lesion as documented by 68Ga-DOTATATE PET\u002FCT with SUVmax \\> SUVmax of the liver consistent with Krenning score of \\>2 or SUVmax \\>= 13 based on scan performed within 12 weeks of anticipated enrollment.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant or breastfeeding.\n* NET\u002FPET score of 5 by imaging with 68Ga-DOTATATE PET\u002FCT and 18FDG-PET\u002FCT and defined more than 2 lesions that are SSTR2 negative but 18FDG positive and\u002For more than 2 lesions that have significantly higher uptake of 18FDG than 68Ga-DOTATATE\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTA-EB-TATE as assessed from medical record.\n* Patient weight \\> 500 lbs. (due to the PET scanner table limit).\n* Inability to tolerate at least one modality of diagnostic anatomic imaging, such as CT or MRI.\n* Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 4 weeks or 4 half-lives (whichever is longer), before the first administration of study drug.\n* Previous surgery \\\u003C 6 weeks prior to the start of participation in this study, or participant has not fully recovered from major surgery, or has suffered significant traumatic injury prior the first dose of study drug or expects to have major surgery during the study period or within 3 months after the last dose of study drug.\n* Life expectancy \\\u003C 6 months as assessed by the treating physician.\n* Karnofsky performance status scale \\\u003C 70%.\n* Inability or unwillingness to use adequate contraception prior to study entry and for the duration of study participation, including follow-up (7 months after the last dose of study drug for women and 4 months for men). The adequate contraception consists of intrauterine device, contraceptive implant, hormonal contraception or a double-barrier method. If the patient is status post tubal ligation, status post hysterectomy and\u002For oophorectomy, or their male partners are status post vasectomy, no additional method of contraception is required.\n* Deteriorated renal function, as indicated by a creatinine clearance \\\u003C60 mL\u002Fmin calculated by the Cockcroft-Gault Equation. The calculated creatinine clearance can be confirmed by measured creatinine clearance.\n* Having only one functional kidney, due to potential nephrotoxicity.\n* Patients who have had any prior EBRT dose to either kidney.\n* Deteriorated bone marrow function, as indicated by:\n\n  * Hemoglobin (Hb) \\\u003C 8.0 g\u002FdL\n  * White blood cell (WBC) \\\u003C 2 x10\\^3\u002FuL\n  * Absolute neutrophil count (ANC) \\\u003C 1.0 x 10\\^3\u002FL\n  * Platelets \\\u003C100 x 10\\^3\u002FmicroL\n* Deteriorated liver function, as indicated by one or more of the following:\n\n  * International normalized ratio (INR) \\> 2.0 for patients that are not on Coumadin\n  * Prothrombin time (PTT) \\> 2 x ULN\n  * Total bilirubin \\> 3 mg\u002FdL\n  * Serum albumin \\\u003C 3.0 g\u002FdL unless prothrombin time is within the normal range\n  * Alanine aminotransferase (ALT) \\> 3 x ULN\n  * Aspartate aminotransferase (AST) \\> 3 x ULN.\n* Previous local therapy \\\u003C4 weeks prior to study entry.\n* Extended QTc interval above 480 ms confirmed by 2 ECGs. If the first ECG conducted at the screening visit shows extended QTc interval, potential participants will be asked to repeat an ECG within 30 days to confirm. The second ECG can be conducted at NIH CC or at their outside provider, at their potential expense.\n* Toxicities from prior therapies that have not resolved to grade 1 or grade 0 excluding dry mouth syndrome from previous RAI and grade 2 anemia\u002Fleukopenia as Hgb\\>=8 g\u002Fdl, WBC \\>=2 x10\\^3\u002FuL and ANC \\>= 1.0 x 10\\^3 are acceptable for enrollment.\n* Active and clinically significant bacterial, fungal, or viral infection, including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness. Radiolabeled ligands may affect the immune response, so people with active and clinically significant infections may become too immunocompromised through participation in this study.\n* Known brain metastases and\u002For carcinomatous meningitis unless these metastases have been treated and stabilized.\n* Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Prior external beam radiation therapy involving \\>25% of the bone marrow.\n* Unmanageable urinary incontinence rendering the administration of 177Lu-DOTA-EB-TATE unsafe.\n* Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence.\n* Is unwilling or unable to establish care with a local provider outside of NIH CC\n* Inability to understand or unwilling to sign a written informed consent document.",{"count":216,"type":22},18,[56,81],"Background:\n\nOncocytic (Hurthle cell) thyroid cancer (HTC) is a rare disease with few treatment options. Researchers are developing a radioactive drug that targets a protein that appears in high numbers on HTC cancer cells.\n\nObjective:\n\nTo test a radioactive drug (177LuDOTA-EB-TATE) in people with HTC.\n\nEligibility:\n\nPeople aged 18 years and older with HTC. The HTC must have failed to respond to conventional radioactive treatment; it must also have spread to other parts of the body.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have imaging scans and a test of their heart function.\n\n177LuDOTA-EB-TATE is infused into a vein. Participants will receive 4 infusions spaced 8 to 12 weeks apart. They will stay in the hospital for 4 to 10 days after each infusion. During and after each infusion, participants will remain in a lead-lined room until their radiation levels go down; this usually takes about 24 hours.\n\nParticipants will have 4 to 6 follow-up visits in the weeks after each infusion. Procedures will vary at each visit, but may include more imaging scans; blood and urine tests; and tests of heart function. Participants will have 2 single-photon emission computerized tomography (SPECT) scans. SPECT scans show where the study drug is sticking to tumors or maybe other parts of their body. They will lie on a table while a machine rotates around them. Participants will fill in questionnaires about how their thyroid condition affects their life.\n\nParticipants will have follow-ups visits for 5 years after their last study treatment.",[220],"Thyroid Cancer",[220,222,223],"H(SqrRoot) rthle cell thyroid cancer","177Lu-DOTA-EB-TATE",{"date":34,"type":35},{"date":37,"type":22},{"date":227,"type":22},"2032-08-01",{"name":41,"class":42},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":54,"phases":238,"briefSummary":240,"conditions":241,"keywords":243,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":252,"locationsCount":43},"100053884","diet-order-effects-of-low-fat-vs-low-carb-diets-on-body-fat-change-100053884","NCT06325722","Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Adults aged 18-50 years\n3. Weight stable (\\\u003C +\u002F- 5% over past 6 months) as determined by volunteer report\n4. Body mass index (BMI) \\>= 25 kg\u002Fm\\^2\n5. Agreement to adhere to Lifestyle Considerations throughout the study duration\n\nEXCLUSION CRITERIA:\n\n1. Subjects with cardiac pacemakers or other implants that may be affected by or affect the DXA measurements\n2. Inadequate access to equipment required for the study (e.g., too little refrigerator storage space or a microwave oven that is too small) as determined by discretion of PI and\u002For study team\n3. Evidence of diseases or conditions that may influence appetite (e.g., cancer, diabetes, alterations of smell or taste post COVID-19), diseases or conditions that affect the immune system, or other conditions at the discretion of the PI and\u002For study team\n4. Taking prescription medications or other drugs that may influence metabolism (including but not limited to diet\u002Fweight-loss medication, some psychiatric medications, or other medications at the discretion of the PI and\u002For study team)\n5. People unlikely to adhere to a relatively consistent daily and weekly routine and avoid travel during their participation in the study. For example, people with occupations such as pilots, flight attendants, or frequently travel for work or pleasure.\n6. People unlikely to abstain from off study food or supplements that may impact metabolism or appetite at the discretion of the study team\n7. Positive pregnancy test or lactating as determined by volunteer report (women only)\n8. Inability or unwillingness to use birth control between screening and completion of the study (women only)\n9. Symptoms or signs of perimenopause or menopause by volunteer report (women only)\n10. Regular vigorous exercise \\>150 min per week as determined by volunteer report\n11. Alcohol consumption \\> 3 drinks per day as determined by volunteer report\n12. Regular use of tobacco (smoking, chewing, or vaping), nicotine replacement therapy, or illicit drugs over past 6 months as determined by volunteer report. Subjects may also be excluded based on a urine drug test.\n13. Psychological conditions as determined by DSM-5 Self-rated Level 1 Cross-cutting Symptom Measure such as (but not limited to) eating disorders, depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators\n14. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) or a reported dislike of a significant fraction of the study foods\n15. Volunteers unwilling or unable to give informed consent\n16. Non-English speakers due to unavailability of required questionnaires in other languages\n17. Resting Energy Expenditure test result within 10% of the 2500 calorie requirement at rest","50 Years",{"count":237,"type":22},42,[239],"NA","Background:\n\nIn a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home.\n\nObjective:\n\nTo test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks.\n\nEligibility:\n\nAdults aged 19 to 50 years with a body mass index of 25 or more.\n\nDesign:\n\nParticipants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples.\n\nParticipants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants' homes. They will eat only the foods delivered.\n\nParticipants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period....",[242,29],"Overweight",[244,245,246,247],"Diet","Body Fat","Nutrition","weight-loss",{"date":34,"type":35},{"date":250,"type":35},"2024-08-28",{"date":111,"type":22},{"name":41,"class":42},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":270,"leadSponsor":272,"locationsCount":43},"100054147","discovering-determinants-of-food-intake-by-application-of-artificial-intelligence-to-complex-high-dimensional-data-100054147","NCT07637656","Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data","Discovering Determinants of Food Intake by Application of Machine Learning to Complex, High-Dimensional Data","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Age 18 to 60\n3. In good general health as evidenced by medical history and physical exam\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Weight \\>=204 kg (\\>=450 pounds, maximum weight of the iDXA machine as per manufacturer s manual), or weight \\\u003C45.4 kg (\\\u003C100 pounds, minimum weight allowed based on the NIH guidelines of blood drawing for research purposes)\n2. Unstable weight (+\u002F-5%) within past 6 months as determined by volunteer self-report.\n3. Current use of medications, dietary supplements, or alternative therapies known to alter energy metabolism\n4. Inability to consume provided food based on food allergy or intolerance or other food restrictions (e.g., kosher, vegan, or vegetarian)\n5. Current pregnancy, or recent pregnancy within past 6 months or currently lactating\n6. History or clinical manifestation of:\n\n6i. Diabetes, including fasting glucose \\>= 126 mg\u002Fdl or HbA1c \\>= 6.5%, or history\n\n6ii. Surgery for treatment of obesity\n\n6iii. Endocrine disorders, such as Cushing s disease, pituitary disorders, or hypo- and hyperthyroidism (TSH \\\u003C0.1 or \\>= 10 uIU\u002FmL)\n\n6iv. Pulmonary disorders including chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol\n\n6v. History of coronary artery disease, heart failure, arrhythmias, and peripheral artery disease that which would limit ability to follow the protocol\n\n6vi. Liver disease, including cirrhosis, active hepatitis B or C based on history, and AST or ALT \\>= 3x normal\n\n6vii. Gastrointestinal disease including Crohn's disease, ulcerative colitis, celiac disease, or other malabsorptive disorders by history\n\n6viii. Hematologic disorders including significant anemia (male hemoglobin \\\u003C 13.0 g\u002FdL or female hemoglobin \\\u003C 11.0 g\u002FdL)\n\n6ix. Renal disease including abnormal kidney function (eGFR \\\u003C60 mL\u002Fmin\u002F1.73m\\^2)\n\n6x. Central nervous system disease, including cerebrovascular accidents, dementia, and neurodegenerative disorders by history\n\n6xi. Cancer requiring treatment in the past 5 years, except for nonmelanoma skin cancers or cancers that have clearly been cured\n\n6xii. Infectious disease such as active tuberculosis, HIV (by self-report), chronic coccidiomycosis or other chronic infections that might influence appetite\n\n6xiii. Diagnosis of binge eating disorder, anorexia, or major psychiatric disorders including depression, schizophrenia, and psychosis\n\n6xiv. Menopausal transition (late) to early postmenopause (e.g., \\>= 2 skipped cycles and an interval of amenorrhea \\>= 60 days and \\\u003C12 months)\n\n7\\. Alcohol abuse as defined by \\>= 8-point score on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire interview\n\n8\\. Inability to provide informed consent\n\n9\\. Any disorder, unwillingness, or inability not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators, such as those that jeopardize the safety of the participant or others, or would interfere with completion of study procedures",{"count":261,"type":22},800,"Background:\n\nMany people in the United States are overweight or obese. Researchers want to learn why some people can overeat and not gain weight, whereas others who do not overeat still gain weight.\n\nObjective:\n\nTo study factors related to food intake that can lead to weight gain over time.\n\nEligibility:\n\nHealthy adults aged 18 to 60 years.\n\nDesign:\n\nParticipants will have 6 to 8 clinic visits over 2 years. The first 3 or 4 study visits will be 1 week apart.\n\nProcedures during visits may include the following:\n\nCollection of blood, hair, urine, and stool samples.\n\nMeasurement of the waist, neck, thighs, and other parts of the body.\n\nDual energy x-ray absorption (DXA) scan: Participants will lie still on a padded table while they are scanned to measure body fat.\n\nPhysical activity monitor: Participants will wear a monitor on the wrist for 2 weeks.\n\nCognitive tests: Participants will perform tasks to measure attention, memory, and brain function.\n\nContinuous glucose monitor. Participants will wear a device that measures their blood glucose for 1 week.\n\nMixed meal test and stomach emptying test. Participants will drink a breakfast shake and swallow a dose of acetaminophen. Blood will be drawn over the next 4 hours.\n\nResting metabolic rate: Participants will wear a clear hood over their head while they rest for 20 minutes. The hood will measure the gases they breathe.\n\nBreakfast and lunch test. Participants will eat a standard breakfast. They will be allowed to select from foods and eat as much as they like at lunch. They will be asked how hungry or full they are.\n\nQuestionnaires. Participants will answer questions about their health, sleep, physical activity, and eating.",[26],[265,266,267],"Food Intake","Energy Expenditure","Artificial Intelligence",{"date":34,"type":35},{"date":37,"type":22},{"date":271,"type":22},"2037-07-01",{"name":41,"class":42},{"id":274,"slug":4,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":275,"targetDuration":4,"studyType":54,"phases":276,"briefSummary":57,"conditions":277,"keywords":278,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":285,"locationsCount":43},"100641283",{"count":53,"type":22},[56],[59],[61,62,59],"2026-07-01",{"date":281,"type":35},"2026-07-02",{"date":283,"type":22},"2026-07-07",{"date":67,"type":22},{"name":41,"class":42},{"id":287,"slug":4,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":169,"enrollmentInfo":288,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":171,"conditions":289,"keywords":290,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":293,"leadSponsor":294,"locationsCount":43},"100641419",{"count":144,"type":22},[173,174,175],[177,178,179],{"date":281,"type":35},{"date":283,"type":22},{"date":183,"type":22},{"name":41,"class":42},{"id":296,"slug":4,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":262,"conditions":298,"keywords":299,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":302,"leadSponsor":303,"locationsCount":43},"100641549",{"count":261,"type":22},[26],[265,266,267],{"date":281,"type":35},{"date":283,"type":22},{"date":271,"type":22},{"name":41,"class":42},{"id":305,"slug":4,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":17,"minAge":119,"maxAge":77,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":122,"conditions":307,"keywords":308,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":311,"leadSponsor":312,"locationsCount":43},"100622816",{"count":121,"type":22},[29,124,125],[127,29,128,129],{"date":281,"type":35},{"date":283,"type":22},{"date":133,"type":22},{"name":41,"class":42},{"id":314,"slug":4,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":315,"targetDuration":4,"studyType":54,"phases":316,"briefSummary":146,"conditions":317,"keywords":318,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":321,"leadSponsor":322,"locationsCount":43},"100617066",{"count":144,"type":22},[81],[148,149,150,26,124,151],[153,154,155,156,157],{"date":281,"type":35},{"date":283,"type":22},{"date":161,"type":22},{"name":41,"class":42},{"id":324,"slug":4,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":101,"conditions":326,"keywords":327,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":330,"leadSponsor":331,"locationsCount":43},"100607669",{"count":7,"type":22},[103],[105,106,107],{"date":281,"type":35},{"date":283,"type":22},{"date":111,"type":22},{"name":41,"class":42},{"id":333,"slug":4,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":334,"targetDuration":4,"studyType":54,"phases":335,"briefSummary":218,"conditions":336,"keywords":337,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":338,"startDateStruct":339,"completionDateStruct":340,"leadSponsor":341,"locationsCount":43},"100592308",{"count":216,"type":22},[56,81],[220],[220,222,223],{"date":281,"type":35},{"date":283,"type":22},{"date":227,"type":22},{"name":41,"class":42},{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":76,"sex":17,"minAge":349,"maxAge":350,"enrollmentInfo":351,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":353,"conditions":354,"keywords":356,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":366},"100572195","youth-onset-type-2-diabetes-and-heart-disease-the-young-at-heart-prospective-cohort-study-100572195","NCT06730113","Youth-Onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study","Youth-onset Type 2 Diabetes and Heart Disease: The Young at Heart Prospective Cohort Study","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet the following criteria according to their group:\n\nFour categories of participants will be included in this study and the inclusion criteria for each group are given below:\n\n1. Participants with Y-T2DM\n\n1a.Age 12-25 years\n\n1b.Type 2 diabetes mellitus as defined by fasting blood glucose \\>= 126 mg\u002FdL OR postprandial blood sugar \\>= 200 mg\u002FdL OR Hemoglobin A1c \\>= 6.5% per American Diabetes Association Criteria and one element from the medical history consistent with ADA or AAP guidelines including: family history of diabetes and obesity, maternal or personal history of gestational diabetes, high-risk race and ethnicity, history of cardiovascular disease, hypertension, dyslipidemia, polycystic ovary syndrome, physical inactivity, other clinical conditions associated with insulin resistance (e.g. severe obesity, acanthosis nigricans, prediabetes), small or large for gestational age birth weight, history of breastfeeding, gestational history of illicit drugs including alcohol, smoking OR documentation of type 2 diabetes diagnosed at \\\u003C=25 years of age with verified medical history (as above).\n\n2\\. Youth with overweight\u002F obesity (Y-OW)\n\n2a. Age 12-25 years\n\n2b. For participants \\\u003C 18 years of age, BMI \\>= 85th percentile (overweight) and \\>= 95th percentile (obesity) for age and sex OR\n\n2c. For participants \\>= 18 years of age, BMI \\>=25\\\u003C30 kg\u002Fm\\^2 (overweight) or \\>=30 kg\u002Fm\\^2 (obesity)\n\n2d. Participants with obesity may have a diagnosis of prediabetes, defined as fasting blood glucose 100-125 mg\u002FdL OR postprandial blood sugar 140-199 mg\u002FdL OR HbA1c 5.7-6.4 percent (either during testing at NIH or as previously documented on outside medical record).\n\n3\\. Healthy control lean participants (Y-Lean)\n\n3a. Age 12-25 years\n\n3b. For participants \\\u003C 18 years of age, BMI \\\u003C= 85th percentile for age and sex OR\n\n3c. For participants \\>=18 years of age, BMI 18-24.99 kg\u002Fm\\^2.\n\n3d. HbA1c \\\u003C5.7 percent (either during testing at NIH or as previously documented on outside medical record).\n\n4\\. Biological parents of Y-T2DM, Y-OW and Y-Lean participants\n\n4a. Biological parent of enrolled Y-T2DM, Y-OW and Y-Lean by self-report.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria for their specific group will be excluded from participation in this study:\n\n1\\. Y-T2DM, Y-OW and Y-Lean Participants:\n\n1a. Type 1 diabetes or the presence of \\>2 diabetes auto-antibodies (e.g., GAD-65, IA-2 antigen, Zinc transporter 8 autoantibodies).\n\n1. b. Medical, psychiatric or cognitive disorders that will, in the opinion of the investigators, limit the subject s ability to comply with study procedures (specific obesity-related comorbidities are explicitly permitted, including hypertension, hyperlipidemia, obstructive sleep apnea and non-alcoholic steatohepatitis).\n\n1c. Serious medical illnesses or diseases thought to alter metabolism (including moderate to severe renal disease (\\\u003C 30 mL\u002Fmin\u002F1.73m\\^2), congenital heart disease, Cushing s syndrome, cancer, or other metabolic diseases associated with diabetes or excess weight).\n\n1d. For participants enrolled at the NIH, dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.\n\n1e. Unwilling to comply with all study procedures or to adhere to Lifestyle Considerations throughout study duration.\n\n1f. Pregnancy at the time of the screening visit.\n\n1g. Clinically significant anemia OR Hematocrit below the lower limit of normal for age and sex cutoffs.\n\n1. h. For Y-OW Participants- Meet lab and medical history criteria for Y-T2DM as described in inclusion criterion 1b above.\n\n2\\. Y-Lean participants:\n\nIn addition to the above exclusion criteria, any Y-Lean participant who meets any of the following additional criteria will be excluded from the study:\n\n2a. Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications, vitamins, and hormonal contraceptives. Other medications may be permitted at the discretion of the investigators.\n\n2b. Recent (past 2 months) use of drugs or supplements that alter glucose or lipid metabolism (e.g., niacin, fish oil, red yeast rice)\n\n2c. History of diabetes or abnormal glucose tolerance\n\n2d.. Abnormal screening labs, including the following:\n\ni) ALT or AST \\>2 times the upper limit of normal\n\nii) Glycosuria\n\niii) Low eGFR (\\\u003C90 mL\u002Fmin\u002F1.73m\\^2)Any other abnormality that, in the opinion of the investigator, will increase risk to the subject from participation, or interfere with interpretation of study data\n\n2e. Meet lab and medical history criteria for Y-T2DM as described in inclusion criterion 1b above.\n\n3\\. Biological Parents\n\n-No Exclusion Criteria","12 Years","25 Years",{"count":352,"type":22},930,"Background:\n\nType 2 diabetes is a disease that affects blood sugar levels. Complications can include heart and blood vessel (vascular) diseases. Rates of type 2 diabetes have tripled in children and young adults over the last 40 years. Vascular diseases are also increasing in young people.\n\nObjective:\n\nTo learn more about factors, including type 2 diabetes, that may cause vascular disease in young people.\n\nEligibility:\n\nPeople aged 12 to 25 years who (1) have type 2 diabetes; (2) are overweight but not diabetic; (3) or are lean and healthy. Biological parents are also needed.\n\nDesign:\n\nYoung participants will visit the NIH clinic once a year for up to 25 years. Each visit will take 4 days. Before each visit, participants will wear devices to track their sleep, activity, and blood sugar levels for 7 to 10 days.\n\nAt each visit, participants will have tests including:\n\nSamples: They will provide blood, urine, and stool samples.\n\nHeart: They will ride a stationary bike for 6 minutes with stickers applied to their chest.\n\nScans: They will lie on a bed that slides into a tube; the machine will take pictures of the inside of their body.\n\nEnergy: They will wear a hood over their head to measure the air they breathe.\n\nSocial stress: They will give a speech for 10 minutes to show their body s response to stress.\n\nGlucose: They will drink a sweet drink to see how their blood sugar changes.\n\nBiological parents will have 1 study visit. They will have blood tests. They will fill in questionnaires about their lifestyle and stress.\n\n...",[29,355],"Type 2 Diabetes",[357,242,29,358,359],"Cardiovascular Disease","Youth Onset Type 2 Diabetes","Lean",{"date":281,"type":35},{"date":362,"type":35},"2025-03-12",{"date":364,"type":22},"2033-10-31",{"name":41,"class":42},2,{"id":368,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":370,"keywords":371,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":374,"leadSponsor":375,"locationsCount":43},"100569134",{"count":21,"type":22},[26,27],[26,29,30],{"date":281,"type":35},{"date":283,"type":22},{"date":39,"type":22},{"name":41,"class":42},{"id":377,"slug":4,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":17,"minAge":192,"maxAge":193,"enrollmentInfo":378,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":196,"conditions":379,"keywords":380,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":383,"leadSponsor":384,"locationsCount":43},"100494748",{"count":195,"type":22},[198],[200,201,202],{"date":281,"type":35},{"date":283,"type":22},{"date":206,"type":22},{"name":41,"class":42},{"id":386,"slug":4,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":17,"minAge":18,"maxAge":77,"enrollmentInfo":387,"targetDuration":4,"studyType":54,"phases":388,"briefSummary":82,"conditions":389,"keywords":390,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":393,"leadSponsor":394,"locationsCount":43},"100494101",{"count":79,"type":22},[81],[84,29],[29,86,84,87],{"date":281,"type":35},{"date":283,"type":22},{"date":91,"type":22},{"name":41,"class":42},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":193,"enrollmentInfo":401,"targetDuration":4,"studyType":54,"phases":403,"briefSummary":404,"conditions":405,"keywords":406,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":411,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":43},"100350346","phase-2-the-use-of-124-i-petct-whole-body-and-lesional-dosimetry-in-differentiated-thyroid-cancer-100350346","NCT03841617","The Use of 124-I-PET\u002FCT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer","* INCLUSION CRITERIA:\n* Patients with established thyroid cancer diagnosis based on the pathology report reviewed at the National Institutes of Health, who:\n\n  * underwent total thyroidectomy plus or minus neck lymph node dissection as clinically indicated,\n  * are presenting with known per structural imaging (US neck, CT or MRI neck\u002Fchest\u002Fabdomen\u002Fpelvis) persistent\u002Frecurrent disease either locally advanced or presenting with distant metastases; or\n  * are presenting with suspected persistent\u002Frecurrent locoregional or distant metastases based on the high risk features such as advanced tumor per pathology report (tumor size \\>4 cm, exrathyroidal extension, higher risk pathology such as tall cell, columnar cell, poorly differentiated variant, follicular thyroid cancer with gross vascular invasion, positive margins after the surgery, bulky lymphadenopathy in the central and\u002For lateral neck), detectable\u002Fincreasing baseline\u002Fsuppressed thyroglobulin (Tg) level or detectable\u002Fincreasing anti-Tg antibody titers if anti-Tg antibodies are present.\n  * are either RAI -naive or requiring repeated RAI therapy for locally advanced disease or distant metastases or underwent therapy with BRAF inhibitor (dabrafenib or vemurafenib\\*) or selumetinib\\*\\* for at least 4 weeks that may re-induce RAI uptake.\n  * Underwent imaging with either a CT or MRI of the brain and spine with gadolinium contrast to screen for the brain\u002Fspine metastases.\n\n    * Age greater than or equal to 18 years of age.\n    * 24 hour urine iodine excretion of less than or equal to 150 micro grams\u002F24 hour.\n\n      * BRAF inhibitors are recommended by 2021 NCCN guidelines as one of the management options for BRAF mutant tumors(13,14)\n\n        * Selumetinib has an FDA orphan drug designation for adjuvant treatment of metastatic thyroid cancer to re-induce RAI uptake\n\nEXCLUSION CRITERIA:\n\n-Patients with RAI-non avid disease documented by negative post-therapy whole body scans performed after previous RAI treatments and not subjected to re-differentiation therapy.\n\n* Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma, severe depression which might be exacerbated by thyroid hormone withdrawal.\n* Patients with spinal or brain metastases as they are at risk of TSH-stimulation induced swelling of metastatic lesions leading to potentially detrimental side effects. These patients will be evaluated per the standard of care protocol 77-DK-0096.\n\n  * Pregnant or lactating women per self report.\n  * Adults who are incapable of providing informed consent.",{"count":402,"type":22},30,[81],"Study rationale\n\nHigh risk patients with differentiated thyroid cancer (DTC) require therapy with 131 I under thyroid stimulating hormone (TSH) stimulation. There are two methods of TSH stimulation endogenous by thyroid hormone withdrawal (THW) leading to hypothyroidism and exogenous by injection of human recombinant TSH (rhTSH Thyrogen). The appropriate 131-I activity utilized for treatment is either based on empiric fixed dosage choice or individually determined activity based on 131 I dosimetric calculations. Although dosimetry utilizing radioactive iodine isotope 131 I enables calculation of maximum safe dose, it does not estimate the tumoricidal activity necessary to destroy the metastatic lesions. The alternative radioactive isotope of iodine -124 I, used for positron emission tomography (PET) imaging, might be used for calculation not only the maximum safe131 I dose, but also to predict the absorbed dose in the metastatic lesions.\n\nStudy objectives\n\nThe primary objective of this study is to compare the 124 I -PET\u002FCT lesional and whole body dosimetry in each individual patient with metastatic radioiodine (RAI)-avid thyroid cancer under preparation with rhTSH and THW. The secondary objective is to evaluate the predicted by PET\u002FCT lesional uptake with the early response to therapy.\n\nStudy design\n\nThis is a phase 2 pilot prospective cohort study comparing the lesional and whole body dosimetry within each patient undergoing exogenous (rhTSH) and endogenous (THW) TSH stimulation and followed for 5 years.\n\nInterventions\n\nEach study participant will undergo rhTSH and THW-aided 124 I-PET\u002FCT dosimetric evaluations and will be subsequently treated with THW-aided RAI activity based on dosimetric calculations enabling maximum safe dosage. The patients will be followed in 12+\u002F-3 months intervals for 5 years.\n\nSample size and population\n\nThis pilot study will include 30 patients with high risk differentiated thyroid cancer presenting with distant and\u002For loco-regional metastases.",[220],[220,407,408,409,410],"PET\u002FCT","124-I","Radioiodine","Metastases",{"date":281,"type":35},{"date":413,"type":35},"2019-07-29",{"date":415,"type":22},"2035-11-01",{"name":41,"class":42},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":76,"sex":17,"minAge":423,"maxAge":424,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":427,"conditions":428,"keywords":432,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":43},"100469897","a-natural-history-study-of-metabolic-sizing-in-health-and-disease-100469897","NCT05398783","A Natural History Study of Metabolic Sizing in Health and Disease","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all the following criteria for their cohort:\n\nCohort 1 - Healthy Volunteers\n\n* Male or female, aged \\>=2 years\n* In good general health as evidenced by medical history\n\nCohort 2 - Patients\n\n* Male or female, aged \\>=2 years\n* Diagnosed with diseases thought to alter metabolism or body composition (such as weight loss or gain, diabetes, renal disease, obesity, cancer, etc.) or taking medications thought to alter metabolism or body composition.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Participants over 200 kg due to the weight limit of the equipment.\n* Presence of any implanted device that would interfere with measurements.\n* Any moderate to severe limitations in mobility that would impede participation\n* Hemoglobin less than 10 g\u002FdL (in participants who would have blood drawn for research purposes).\n* Participants with dietary allergies, intolerances or eating patterns that would preclude them from consuming metabolic meals.\n* Participants unwilling or unable to give informed consent.\n* Participants with any other significant physical, medical, or psychiatric limitations, illness or conditions that may preclude them from completing the majority of the tests in this study per the discretion of the PI.","2 Years","99 Years",{"count":426,"type":22},2000,"Background:\n\nScientists have long used simple measures (such as height and weight) to estimate how much a person s body uses food (calories) as energy, as commonly called the metabolic rate. But metabolism varies among people with similar body sizes. Scientists now believe the old formulas for estimating metabolic rates may not work well for all people. Researchers want to find more accurate ways to measure a person s metabolism.\n\nObjective:\n\nThis natural history study will examine the relationships between metabolism, body composition, and body surface area in a wide range of people.\n\nEligibility:\n\nHealthy children and adults aged 2 years or older. Also, people aged 2 years or older with conditions that may alter metabolism. These may include diabetes, obesity, renal disease, or cancer.\n\nDesign:\n\nParticipants will spend 2 days and 1 night in the hospital. They will provide a medical history and answer questions about their activity levels, the foods they eat, and their lifestyle. They will also eat a special diet.\n\nParticipants will undergo many tests:\n\nThey will lie in a bed with a clear hood covering their head for 30 to 45 minutes to measure the gases in their breath.\n\nThey will lie on a padded table for about 15 minutes while their body is scanned.\n\nThey will stand on a platform while a 3D scanner measures their body.\n\nThey will have a test to measure how fast an electric signal moves through their body.\n\nThey will grip an instrument to measure the strength of their hands.\n\nThey will drink salty water and provide blood and urine samples.\n\nParticipants may be invited to return for these 2-day visits up to 8 times per year. Return visits must be at least 2 weeks apart.",[125,429,430,124,431],"Cancer","Chronic Kidney Disease","Normal Physiology",[433,434,435,202],"Body Composition","Metabolism","Body Surface Area","2026-06-30",{"date":279,"type":35},{"date":439,"type":35},"2022-10-25",{"date":441,"type":22},"2031-07-01",{"name":41,"class":42},{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":76,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":450,"targetDuration":4,"studyType":54,"phases":452,"briefSummary":453,"conditions":454,"keywords":457,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":43},"100353606","phase-2-non-alcoholic-fatty-liver-disease-the-hepatic-response-to-oral-glucose-and-the-effect-of-semaglutide-nafld-heroes-100353606","NCT03884075","Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)","Non-Alcoholic Fatty Liver Disease, the Hepatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)","* INCLUSION CRITERIA:\n\n  1. Male or female Aged \\>= 18 years of age.\n  2. Histological evidence of hepatic steatosis on a liver biopsy within 12 months OR evidence of fatty liver disease, as documented by imaging (ultrasound, CT, MRI, MRI-PDFF, MR spectroscopy, or Fibroscan CAP \\>= 285 db\u002FM25) within 12 months.\n  3. Estimated average alcohol consumption \\\u003C 30 g\u002Fd for men or \\\u003C 20 g\u002Fd for women in the 6 months prior to enrollment and no binge-drinking behavior.\n  4. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nAdditional Inclusion Criteria for Treatment Phase\n\n1. Presence of NAFLD (steatosis grade greater than or equal to 1 on NASH-CRN scoring scale) on baseline admission liver biopsy.\n2. Liver fat content greater than or equal to 10% by 1H-MRS on initial admission.\n\nEXCLUSION CRITERIA:\n\n1. Pregnant or breast-feeding\n2. Chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who were treated successfully for HCV and achieved sustained virological response can be eligible for enrollment \\> 18 months after treatment cessation. Patients receiving antiviral therapy are ineligible.\n3. HIV infection.\n4. Concomitant liver disease such as autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson s disease, alpha-1 antitrypsin deficiency, hereditary hemochromatosis.\n5. Presence of definite or probable drug-induced liver injury. In the case of lipid-lowering, anti-hypertensive or anti-diabetic medications that are suspected to cause aminotransferase elevation, patients will be eligible if treatment is associated with stable enzyme levels for at least 6 months.\n6. Decompensated advanced liver disease, defined as direct bilirubin \\> 0.5 g\u002FdL, PT \\> 18 , albumin \\\u003C 3 g\u002FdL, MELD score \\> 12 (applicable only in patients without Gilbert s syndrome), or history of ascites, encephalopathy, variceal bleeding, spontaneous bacterial peritonitis or liver transplant\n7. Treatment with medications known to cause fatty liver disease such as atypical neuroleptics, tetracycline, methotrexate or tamoxifen\n8. Uncontrolled hypo- or hyperthyroidism.\n9. Thyroid nodules with ultrasonographic features suggestive of an increased risk of thyroid cancer per radiologist reporting (hypoechoic, microcalcifications, twinkling on B flow imaging, central vascularity, irregular margins, incomplete halo, nodule taller than wide and documented enlargement of a nodule), or nodules associated with an abnormal TSH (0.4 to 5 mU\u002FL).\n10. Active coronary artery disease, defined as persistent angina pectoris, reversible ischemia on cardiac stress test or imaging, or the presence of significant coronary artery disease on imaging or catheterization. Patients with coronary artery disease that was treated by angioplasty or bypass surgery may be eligible if they have no evidence of active disease \\>= 1 year after intervention, can safely stop antiplatelet and anticoagulant medications before the performance of invasive procedures, and have adequate ventricular function as assessed by echocardiography or cardiology consultation. These patients will require cardiology consultation and clearance prior to enrollment.\n11. Congestive heart failure.\n12. Chronic kidney disease, with creatinine clearance \\\u003C 60 ml\u002Fmin or eGFR \\\u003C 60\u002Fml\u002Fmin\u002Fm(2).\n13. Uncontrolled diabetes mellitus with HbA1c \\> 9% will exclude subjects. Patients with diabetes may be enrolled only if they have HbA1c \\\u003C=9%, have been on stable therapy with lifestyle and\u002For metformin for at least 3 months prior to enrollment, and are not foreseen to require change of antidiabetic medication or dose during the trial.\n14. Use of insulin, sulfonylurea agents, thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists or DPP-4 inhibitors unless discontinued greater than or equal to 3 months before enrollment.\n15. Contraindication or inability to perform a liver biopsy.\n\n    1. Patients with coagulopathy (PT\u002FPTT values that are prolonged greater than or equal to 3 seconds from the upper limit of the normal, including treatment with oral and parenteral anticoagulants), thrombocytopenia (\\\u003C 70,000), abnormal bleeding time or platelet dysfunction. Antiplatelet agents taken for cardiovascular prevention will not exclude patients, unless they cannot be stopped safely for the performance of a liver biopsy.\n    2. Hemoglobin level \\\u003C 11 g\u002FdL\n16. Contraindications to MRI (heart pacemakers, unless MRI safe, insulin pumps, implanted hearing aids, neurostimulators, intracranial metal clips, metallic bodies in the eye, metal hip replacements, sutures, extreme anxiety or fear of small spaces.)\n17. History of gastric bypass or other bariatric surgery, partial or complete gastrectomy and known maldigestion or malabsorption.\n18. Treatment with orlistat.\n19. Patients with uncontrolled eating disorders including anorexia and bulimia nervosa.\n20. Patients with proliferative diabetic retinopathy.\n21. Use of medications or supplements to treat NAFLD (approved or unapproved) unless withdrawn greater than or equal to 3 months prior to enrollment or taken at a stable dose for greater than or equal to 6 months.\n22. Patients who had a liver biopsy performed less than or equal to 2 years before enrollment, unless they are willing to undergo all of the trial biopsies, knowing that these biopsies are purely for research and are not clinically indicated. This will be clearly documented in the patients charts prior to enrollment.\n23. Inability or unwillingness to receive subcutaneous injections.\n24. Known or suspected allergy to trial medication(s), excipients, or related products.\n25. Alcohol or substance abuse within the past 12 months.\n26. For women of childbearing potential, breast-feeding, pregnancy or inability or unwillingness to practice contraception for the duration of the study.\n27. Personal or first-degree family member with history of medullary thyroid carcinoma or subjects with known multiple endocrine neoplasia syndrome type 2 (MEN-2).\n28. Actively pursuing an intensive weight loss regiment, aimed at losing \\> 10% of current body weight, by following a different diet or exercise regimen over the study time period or recent (\\\u003C3 months) significant weight loss (\\>10%).\n29. The receipt of any investigational drug within 3 months prior to enrollment in this trial.\n30. Assessment by the principal investigator that the subject will be unlikely to complete the study procedures, or that enrollment puts the subject at a significant risk unspecified by the criteria above.\n\nINCLUSION CRITERIA for Healthy Volunteers (arm C)\n\n1. Male or female Aged greater than or equal to 18 years of age.\n2. No evidence of hepatic steatosis by imaging or histology.\n3. No history of known liver disease.\n4. Individuals on regular systemic medications may be considered eligible, and their eligibility will be determined by the principal investigator.\n5. BMI less than or equal to 25 kg\u002Fm2\n6. Non-diabetic.\n7. Normal transaminases (ALT less than or equal to 31 U\u002FL for men or less than or equal to 19 U\u002FL for women, and AST less than or equal to 30 U\u002FL).\n8. Fasting glucose less than or equal to 95 mg\u002FdL.\n9. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA for Healthy Volunteers (arm C)\n\n1. Pregnant or breastfeeding\n2. Excessive alcohol consumption, defined as an average alcohol consumption over \\> 1 drink per day over the past month\n3. Assessment by the principal investigator that the subject is unsuitable for participation in the study or that enrollment puts the subject at significant risk.",{"count":451,"type":22},104,[81],"Background:\n\nIn non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication can help.\n\nObjective:\n\nTo find out how the liver in people with NAFLD responds to feeding, and how this relates to their response to the drug semaglutide.\n\nEligibility:\n\nPeople with NAFLD and healthy volunteers ages 18 and older\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood tests\n\nImaging: A machine will take pictures of the participant s body.\n\nWithin 2-8 weeks of enrollment, participants will stay in the clinic for several days. This includes:\n\nBlood, urine, heart, and imaging tests\n\nFor NAFLD participants only: A needle-like device will remove a small biopsy of the liver and fatty tissue.\n\nParticipants will be alone in a special room for 5 hours. They will breathe through a tube under the nostrils. They will have blood drawn several times.\n\nThe baseline visit concludes participation for healthy volunteers but NAFLD participants will contine.\n\nAbout 6 weeks after discharge, participants will stay in the clinic again and repeat the tests. They will get their first semaglutide dose by injection.\n\nParticipants will have visits weeks 1, 2, 4, 8, 12, 16, 20, and 24 of treatment. Visits include blood tests.\n\nParticipants will inject semaglutide once a week at home.\n\nAt week 30, participants will stay in the clinic again and repeat the tests.\n\nParticipants will have a final visit 12 weeks after stopping treatment. This includes blood and urine tests.\n\n...",[455,456],"Non-Alcoholic Steatohepatitis","Non-Alcoholic Fatty Liver Disease",[458,459,460],"Non-Alcoholic Steatohepatitis (NASH)","Steatosis","Caloric Load",{"date":279,"type":35},{"date":463,"type":35},"2019-07-24",{"date":465,"type":22},"2026-10-02",{"name":41,"class":42},""]