[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06571474":3,"trial-entities:NCT06571474":100,"trial-summary:NCT06571474":105},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":22,"study_type":23,"primary_purpose":15,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":44,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":68,"locations":71,"central_contacts":86,"overall_officials":94,"references":98,"see_also_links":99},"NCT06571474","2098077A","Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity (ATM)","Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity-Associated Diseases","RECRUITING","2028-03","2026-08","2026-08-06","2024-08-01","Bettina Mittendorfer","OTHER",null,"The goal of this study is to evaluate the role of transcription factor EB (TFEB) in adipose (fat) tissue macrophages (ATM) in regulating adipose tissue and systemic metabolic function in obesity. The investigators will assess the differences in ATM lipid metabolism in people with metabolically abnormal obesity and lean individuals.\n\nBoth groups will have:\n\n* screening visit\n* imaging (body composition testing - dual-energy x-ray absorptiometry (DEXA) scans, magnetic resonance imaging \\[MRI\\] and magnetic resonance spectroscopy \\[MRS\\] scans)\n* Overnight visit with intravenous infusion (IV), muscle, and fat tissue biopsies",[18,19,20,21],"Obesity","Non-Alcoholic Fatty Liver Disease","Diabetes Mellitus, Type 2","Healthy",[],"OBSERVATIONAL",[],{"count":26,"type":27},60,"ESTIMATED",[],[30,34,36,39],{"measure":31,"description":32,"timeFrame":33},"Insulin sensitivity","Sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure","Within 2 weeks of Clinical Visit",{"measure":35,"timeFrame":33},"24-hour plasma glucose concentration",{"measure":37,"description":38,"timeFrame":33},"Macrophage isolation in adipose tissue biopsy","macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS)",{"measure":40,"description":38,"timeFrame":33},"Macrophage isolation in skeletal muscle tissue",[],"ALL","18 Years","70 Years",true,{"inclusion":47,"exclusion":66,"raw_text":67},[48,49,50,51,52,53,54,55,56,57,58,59,55,56,60,58,61,62,63,64,58,65],"age: ≥18 but ≤70 years","not pregnant or breastfeeding","weight stable and sedentary before enrollment","no use tobacco products, excessive amounts of alcohol, or dietary supplements, or medications known to or suspected to affect glucose and lipid metabolism (aside from certain medications used to treat diabetes in the metabolically abnormal obesity \\[MAO\\]-Type 2 Diabetes group)","no evidence of significant organ system dysfunction or disease (e.g. chronic severe kidney disease, cancer)","Body mass index (BMI) ≥18.5 but \\\u003C25.0 kg\u002Fm2","Intrahepatic triglyceride (IHTG) content \\\u003C5%","fasting blood glucose concentration: \\\u003C100 mg\u002Fdl","blood glucose concentration 2 h after a 75 g oral glucose challenge: \\\u003C140 mg\u002Fdl","Hemoglobin A1C (HbA1c) \\\u003C5.7 %","BMI ≥30.0 but \\\u003C45.0 kg\u002Fm2","IHTG content \\\u003C5%","HbA1c \\\u003C5.7 %","IHTG content \\>7.5%","fasting blood glucose concentration: ≥100 but \\\u003C126 mg\u002Fdl","blood glucose concentration 2 h after a 75 g oral glucose challenge: ≥140 but \\\u003C200 mg\u002Fdl","HbA1c: ≥5.7 but \\\u003C6.4 %","clinical diagnosis of type 2 diabetes or fasting blood glucose concentration \\>126 mg\u002Fdl or blood glucose concentration 2 h after a 75 g oral glucose challenge\\>200 mg\u002Fdl or HbA1c \\>6.4 % without medication if not diagnosed and medically treated for diabetes",[],"Inclusion Criteria :\n\n* age: ≥18 but ≤70 years\n* not pregnant or breastfeeding\n* weight stable and sedentary before enrollment\n* no use tobacco products, excessive amounts of alcohol, or dietary supplements, or medications known to or suspected to affect glucose and lipid metabolism (aside from certain medications used to treat diabetes in the metabolically abnormal obesity \\[MAO\\]-Type 2 Diabetes group)\n* no evidence of significant organ system dysfunction or disease (e.g. chronic severe kidney disease, cancer)\n* participants must fulfil all of the following group-specific inclusion criteria below:\n\nLean group:\n\n* Body mass index (BMI) ≥18.5 but \\\u003C25.0 kg\u002Fm2\n* Intrahepatic triglyceride (IHTG) content \\\u003C5%\n* fasting blood glucose concentration: \\\u003C100 mg\u002Fdl\n* blood glucose concentration 2 h after a 75 g oral glucose challenge: \\\u003C140 mg\u002Fdl\n* Hemoglobin A1C (HbA1c) \\\u003C5.7 %\n\nMetabolically normal obesity (MNO) group:\n\n* BMI ≥30.0 but \\\u003C45.0 kg\u002Fm2\n* IHTG content \\\u003C5%\n* fasting blood glucose concentration: \\\u003C100 mg\u002Fdl\n* blood glucose concentration 2 h after a 75 g oral glucose challenge: \\\u003C140 mg\u002Fdl\n* HbA1c \\\u003C5.7 %\n\nMetabolically abnormal obesity (MAO)-insulin resistance and non-alcoholic fatty liver disease (NAFLD) group:\n\n* BMI ≥30.0 but \\\u003C45.0 kg\u002Fm2\n* IHTG content \\>7.5%\n* fasting blood glucose concentration: ≥100 but \\\u003C126 mg\u002Fdl\n* blood glucose concentration 2 h after a 75 g oral glucose challenge: ≥140 but \\\u003C200 mg\u002Fdl\n* HbA1c: ≥5.7 but \\\u003C6.4 %\n\nMAO-type 2 diabetes group:\n\n* BMI ≥30.0 but \\\u003C45.0 kg\u002Fm2\n* clinical diagnosis of type 2 diabetes or fasting blood glucose concentration \\>126 mg\u002Fdl or blood glucose concentration 2 h after a 75 g oral glucose challenge\\>200 mg\u002Fdl or HbA1c \\>6.4 % without medication if not diagnosed and medically treated for diabetes\n\nExclusion Criteria:\n\n\\- Individuals that do not meet all inclusion Criterion",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":83},"University of Missouri School of Medicine","Columbia","Missouri","65212","United States",[79],{"name":13,"role":80,"phone":81,"email":82},"CONTACT","573-882-9377","b.mittendorfer@missouri.edu",{"lat":84,"lon":85},38.95171,-92.33407,[87,91],{"name":88,"role":80,"phone":89,"email":90},"Heather McHatton","573-882-7619","heathermchatton@health.missouri.edu",{"name":92,"role":80,"email":93},"Aman Pritish Aher","amanpritishaher@missouri.edu",[95],{"name":13,"affiliation":96,"role":97},"University of Missouri-Columbia","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":101,"biomarkers":104},[21,102,18,103],"Nonalcoholic Fatty Liver Disease","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":45,"summary":106,"prompt_version":116},{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This is an observational study involving 60 participants. It compares individuals with metabolically abnormal obesity to lean individuals.","completed","Understanding Fat Metabolism in Obesity","This observational study, called ATM, aims to understand how fat cells (adipose tissue) and immune cells (macrophages) process fats in people with obesity, especially those with conditions like non-alcoholic fatty liver disease and type 2 diabetes. Researchers will compare these processes in individuals with metabolically abnormal obesity and healthy, lean individuals. The study is looking for 60 participants between 18 and 70 years old who are not pregnant or breastfeeding, are weight-stable, and don't use tobacco or excessive alcohol. Success will be measured by changes in insulin sensitivity, 24-hour blood sugar levels, and how macrophages are isolated from fat tissue biopsies, all within two weeks of a clinical visit. The study's current status is unclear.","Measurements for insulin sensitivity, 24-hour plasma glucose, and macrophage isolation are taken within two weeks of a clinical visit.",115,"You would have a screening visit, imaging tests (DEXA scans, MRI, and MRS scans), and an overnight visit including an intravenous infusion (IV) and biopsies of muscle and fat tissue.","Not stated in the trial record.",[],"v2"]