[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Foundation for the National Institutes of Health\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100652611","redefining-evaluation-of-adiposity-and-leanness-broadening-objective-diagnostics-for-obesity-100652611",false,"NCT07776678","Redefining Evaluation of Adiposity and Leanness: Broadening Objective Diagnostics for Obesity","Redefining Evaluation of Adiposity and Leanness: Broadening Objective Diagnostics for Obesity (REAL-BODY)","REAL-BODY","Inclusion Criteria:\n\n* Being willing to provide written informed consent prior to participation Being willing to complete the study visits and comply with the study procedures\n* Being willing to travel to the various study locations for On-site, DXA, MRI, and Phlebotomy visits\n* Being willing to change into appropriate form-fitting clothing for 3DO assessments and\u002For appropriate gowns for DXA and MRI imaging\n* Must have a BMI within the range of 18.5 - 45 kg\u002Fm2\n* Being willing to refrain from all food, drink, and substances for 8 hours prior to the On-site visit(s) and phlebotomy visit\n* Being willing to refrain from all food, drink, and substances for 4 hours prior to the DXA and MRI scan visits\n* Being willing to refrain from any exercise or vigorous physical activity for 24 hours prior to all visits\n* Stable weight (no more than 5 kg change) for 3 months prior to screening\n* If recruited in the Phoenix, AZ area, participants must be willing to drive yourself to the Phoenix Office location for the On-site Visits 1 and 2 (if applicable) located at the Exponent Phoenix Office.\n\nExclusion Criteria:\n\n* Being pregnant or attempting to become pregnant\n* Having medical implants, such as a pacemaker or metal joint replacements, or other metal implants contraindicated for MRI\n* Cosmetic implants, such as breast implants\n* Having a height greater than DXA scanning limit (77 inches)\n* Having a body weight greater than indicated for the equipment (400 lbs)\n* Prior amputation or major body-altering surgery that could invalidate body composition estimates\n* Having claustrophobia or a history of claustrophobia\n* Known HIV infection\n* Known Lipodystrophy\n* Known hydration abnormality (e.g., significant edema, end-stage renal disease, end-stage liver disease)\n* Severe illness or life-threatening conditions such as end-stage kidney, liver, lung disease, NYHA III-IV heart failure, or active malignancy","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to evaluate body composition across a variety of medical, professional, and commercial devices, including: bioelectrical impedance analysis (BIA) devices, 3-dimensional optical imaging (3DO), manual anthropometry measurements, dual-energy X-ray absorptiometry (DXA), magnetic resonance imaging (MRI), and blood tests. The secondary study purpose is to compare body composition measurements from BIA devices, 3DO, and manual anthropometry measurements within a 1-week period for a subset of the study population.\n\nThe study plans to enroll 300 healthy (having no life-threatening conditions or diseases; male and female) participants, 18 years of age or older.",[25],"Obesity & Overweight",[27],"Body Composition","RECRUITING","2026-08-17",{"date":31,"type":32},"2026-08-20","ACTUAL",{"date":34,"type":32},"2026-06-29",{"date":36,"type":21},"2027-03-30",{"name":38,"class":39},"Foundation for the National Institutes of Health","OTHER",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100602376","evaluation-of-non-invasive-tests-for-metabolic-liver-disease-100602376","NCT07122700","Evaluation of Non-Invasive Tests for Metabolic Liver Disease","Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) Study 2.0 - An FNIH Biomarkers Consortium Study","NIMBLE","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged \\> 18 years and \\\u003C 75 years\n4. Participants must exhibit some manifestations of metabolic dysregulation. Either:\n\nA. Physician-diagnosed T2DM for at least 90 days with HbA1c \\> 6.5 and antidiabetic therapy, if any, stable for at least 90 days prior to screening or B. At least any one of the following six metabolic syndrome criteria \\[6\\]\n\n1\\. body mass index (BMI) of \\> 25 kg\u002Fm2 2. waist circumference: i. \\> 102 cm for men ii. \\> 88.9 cm for women 3. fasting triglyceride concentration \\> 150 mg\u002FdL i. or ongoing treatment with triglyceride lowering medication 4. HDL-cholesterol concentration: i. \\\u003C 40 mg\u002FdL for men ii. \\\u003C 50 mg\u002FdL for women iii. or ongoing treatment with cholesterol lowering medication. 5. fasting glucose concentration \\> 100 mg\u002FdL 6. either semi-recumbent or supine blood pressure systolic \\> 130 mmHg and\u002F or diastolic \\> 85 mmHg i. or ongoing treatment with antihypertensive medication. 5. FIB-4 \\> 1.3 (age \\\u003C 65 years) and \\> 2.0 (age \\> 65 years) 6. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\n\nExclusion Criteria:\n\n1. Known history or evidence of other forms of chronic liver disease other than MASLD\u002FMASH including but not limited to viral hepatitis B or C, autoimmune liver disease, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease, hemochromatosis, drug-induced liver disease, conditions involving bile duct obstructions, liver cancer, past history of HCC or HCC treatment, listed for or history of liver transplantation, prior resection of liver, etc.\n2. Current or past evidence of decompensated liver disease defined by overt ascites that is clinically obvious and requires diuretic therapy, overt encephalopathy requiring therapy or history of variceal hemorrhage\n3. Circulating Alanine aminotransferase (ALT)\\> 5xULN\n4. Ongoing or recent (within the last two years prior to screening) consumption of significantly greater than moderate amounts of alcohol.\n\n   * A standard alcoholic drink is any drink that contains about 14 g of pure alcohol, such as 12 fluid ounces of regular beer 8-10 fluid ounces of malt liquor or flavored malt beverages such as hard seltzer 5 fluid ounces of table wine 3-4 fluid ounces of fortified wine such as sherry or port 2-3 fluid ounces of cordial liqueur or aperitif 1.5 fluid ounces (a single jigger or shot) of brandy, cognac, or distilled spirits such as gin, rum, tequila, vodka, whiskey, etc.\n   * Significantly greater than moderate alcohol consumption is defined as on average over a 2-year period prior to screening:\n\n   Women\n   * \\>1 standard drink per day and\u002For\n   * \\>14 standard drinks per week Men\n   * \\>2 standard drinks per day and\u002For\n   * \\>21 standard drinks per week in men\n\n     * An Alcohol Use Disorders Identification Test (AUDIT) score of 7 or higher\n     * A PEth test score of ≥ 20ng\u002Fml.\n5. In the opinion of the investigator, any contraindications to liver biopsy including but not limited to having significant uncorrected coagulopathy or thrombocytopenia, on chronic anticoagulation with Direct Oral Anticoagulants (DOACs), or on low dose heparin or Warfarin.\n6. Uncontrolled systolic blood pressure \\> 180 mmHg and diastolic blood pressure \\> 120 mmHg at screening. Blood pressure will be obtained after at least 10 minutes of resting in a semi-recumbent or supine position.\n7. Any systemic disease that in the opinion of the investigator precludes inclusion of the patient in the trial\n8. Unable or unwilling to provide informed consent\n9. Unwilling to undergo liver biopsy procedure\n10. Unable or unwilling to comply with requirements for study procedures (such as fasting)\n11. Unable to perform study procedures in the opinion of the investigator\n12. Participants who are unwilling or unable (e.g. due active implants such as pacemaker or having a waist diameter (calculated as: diameter = circumference \u002F π) 70cm, unless a wide-bore MRI machine is available) to undergo MRI procedures.\n13. Pregnancy or planned pregnancy within 4 months of screening.\n14. Participation in another clinical trial within 30 days, or dosing with an investigational agent within 90 days prior to signing the ICF for this study.","75 Years",{"count":51,"type":21},400,"The Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) study is a comprehensive, multi-year collaborative effort to standardize, validate and advance the regulatory qualification of blood- and imaging-based biomarkers to diagnose and stage Metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). MASH is characterized by liver inflammation accompanied by simultaneous fat accumulation in the liver.",[54,55,56,57,58,59,60,61],"Metabolic Associated Fatty Liver Disease","Metabolic Associated Steatotic Liver Disease","Cirrhosis, Liver","NASH","Liver Fibrosis","Liver Fat","Liver Steatoses","Liver Inflammation","2025-08-07",{"date":64,"type":32},"2025-08-14",{"date":66,"type":32},"2025-05-13",{"date":68,"type":21},"2026-07-31",{"name":38,"class":39},4,""]