[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06335771":3,"trial-entities:NCT06335771":108,"trial-summary:NCT06335771":113},{"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":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":38,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":76,"locations":79,"central_contacts":94,"overall_officials":102,"references":106,"see_also_links":107},"NCT06335771","2098077","Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity","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 Participants with obesity will complete meetings with study team members for a weight loss intervention to achieve a 10% body weight loss.",[18,19,20,21],"Obesity","Nonalcoholic Fatty Liver","Diabetes Type 2","Healthy",[],"INTERVENTIONAL","BASIC_SCIENCE",[26],"NA",{"count":28,"type":29},60,"ESTIMATED",[31],{"type":14,"name":32,"description":33,"armGroupLabels":34},"Dietary consultation weight loss intervention","Participants will meet with a member of the study team biweekly for about 6 months.",[35,36,37],"Individuals with Type 2 Diabetes Mellitus","Metabolically abnormal obese Individuals (obesity with normoglycemia and abnormal liver fat content)","Metabolically normal obese Individuals (obesity with normoglycemia and normal liver fat content)",[39,42,44,47],{"measure":40,"timeFrame":41},"Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure.","up to 6 months after the intervention",{"measure":43,"timeFrame":41},"24-hour plasma glucose concentration",{"measure":45,"description":46,"timeFrame":41},"Macrophage isolation in adipose tissue biopsy","macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS)",{"measure":48,"description":46,"timeFrame":41},"Macrophage isolation in skeletal muscle tissue",[],"ALL","18 Years","70 Years",true,{"inclusion":55,"exclusion":74,"raw_text":75},[56,57,58,59,60,61,62,63,64,65,66,67,63,64,68,66,69,70,71,72,66,73],"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",[77,78],"ADULT","OLDER_ADULT",[80],{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":91},"University of Missouri School of Medicine","Columbia","Missouri","65212","United States",[87],{"name":13,"role":88,"phone":89,"email":90},"CONTACT","573-882-9377","b.mittendorfer@missouri.edu",{"lat":92,"lon":93},38.95171,-92.33407,[95,99],{"name":96,"role":88,"phone":97,"email":98},"Heather McHatton","(573) 882-7619","heathermchatton@health.missouri.edu",{"name":100,"role":88,"email":101},"Aman Pritish Aher","amanpritishaher@umsystem.edu",[103],{"name":13,"affiliation":104,"role":105},"University of Missouri-Columbia","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":109,"biomarkers":112},[21,110,18,111],"Nonalcoholic Fatty Liver Disease","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":53,"summary":114,"prompt_version":124},{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an interventional study planning to enroll 60 participants. It compares individuals with obesity to lean individuals.","completed","Studying Macrophage Lipid Metabolism in Obesity","This study is looking at how fat tissue cells called macrophages (a type of immune cell) handle fats in people with obesity and those who are lean. Researchers want to understand the role of a specific protein, transcription factor EB (TFEB), in these macrophages and how it affects metabolism. Participants with obesity will receive a dietary consultation for weight loss, aiming for a 10% body weight reduction over about 6 months. The study will measure insulin sensitivity (how well your body uses insulin), 24-hour blood sugar levels, and examine macrophages from fat tissue. We are looking for adults aged 18 to 70 who are not pregnant or breastfeeding, are weight stable, and don't use tobacco or excessive alcohol. The study is currently unclear on its recruitment status.","Measurements will be taken up to 6 months after the intervention.",127,"You would have a screening visit, imaging (DEXA, MRI, MRS scans), and an overnight stay with an IV, muscle, and fat tissue biopsies. If you have obesity, you'll also have bi-weekly dietary consultations for about 6 months.","Not stated in the trial record.",[],"v2"]