Status:
RECRUITING
Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity (ATM)
Lead Sponsor:
Bettina Mittendorfer
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-70 years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06571474
Start Date
August 1 2024
End Date
March 1 2028
Last Update
July 22 2025
Active Locations (1)
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1
University of Missouri School of Medicine
Columbia, Missouri, United States, 65212