NCT06335771 · Bettina Mittendorfer
Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity
(ATM)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- \- Individuals that do not meet all inclusion Criterion
Where
- Columbia, Missouri
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 18, 2025 · Source of record for eligibility and locations