NCT06335771Recruiting
Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity
Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity-Associated Diseases
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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. Both groups will have: * screening visit * imaging (body composition testing - dual-energy x-ray absorptiometry (DEXA) scans, magnetic resonance imaging \[MRI\] and magnetic resonance spectroscopy \[MRS\] scans) * 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 14 Mar 2024
- Start date
- Aug 2024
- Primary completion date
- Mar 2028
- Lead sponsor
- Bettina Mittendorfer
- NCT number
- NCT06335771
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Aug 2024 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- Individuals that do not meet all inclusion Criterion
Who the study is looking for
- 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)
- participants must fulfil all of the following group-specific inclusion criteria below:
- Lean group:
- Body mass index (BMI) ≥18.5 but \<25.0 kg/m2
- Intrahepatic triglyceride (IHTG) content \<5%
- fasting blood glucose concentration: \<100 mg/dl
- blood glucose concentration 2 h after a 75 g oral glucose challenge: \<140 mg/dl
- Hemoglobin A1C (HbA1c) \<5.7 %
- Metabolically normal obesity (MNO) group:
- BMI ≥30.0 but \<45.0 kg/m2
- IHTG content \<5%
- fasting blood glucose concentration: \<100 mg/dl
- blood glucose concentration 2 h after a 75 g oral glucose challenge: \<140 mg/dl
- HbA1c \<5.7 %
- Metabolically abnormal obesity (MAO)-insulin resistance and non-alcoholic fatty liver disease (NAFLD) group:
- BMI ≥30.0 but \<45.0 kg/m2
- IHTG content \>7.5%
- fasting blood glucose concentration: ≥100 but \<126 mg/dl
- blood glucose concentration 2 h after a 75 g oral glucose challenge: ≥140 but \<200 mg/dl
- HbA1c: ≥5.7 but \<6.4 %
- MAO-type 2 diabetes group:
- BMI ≥30.0 but \<45.0 kg/m2
- clinical diagnosis of type 2 diabetes or fasting blood glucose concentration \>126 mg/dl or blood glucose concentration 2 h after a 75 g oral glucose challenge\>200 mg/dl or HbA1c \>6.4 % without medication if not diagnosed and medically treated for diabetes
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Missouri School of Medicine Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.