Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity

Not Applicable

Recruiting

• Conditions: Diabetes Type 2; Obesity; Healthy; Nonalcoholic Fatty Liver
• Interventions: Other: Dietary consultation weight loss intervention

• Registration Number: NCT06335771
• Lead Sponsor: Bettina Mittendorfer

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-28
• Status Verified: 2024-08
• Study Start: 2024-08-01
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

• Individuals that do not meet all inclusion Criterion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metabolically abnormal obese Individuals (obesity with normoglycemia and abnormal liver fat content)	Dietary consultation weight loss intervention	Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.
Metabolically normal obese Individuals (obesity with normoglycemia and normal liver fat content)	Dietary consultation weight loss intervention	Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.
Individuals with Type 2 Diabetes Mellitus	Dietary consultation weight loss intervention	Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure.	up to 6 months after the intervention
24-hour plasma glucose concentration	up to 6 months after the intervention
Macrophage isolation in adipose tissue biopsy	up to 6 months after the intervention	macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS)
Macrophage isolation in skeletal muscle tissue	up to 6 months after the intervention	macrophage gene expression using RNA sequencing and fluorescent activated cell sorting (FACS)

Trial Locations

Locations (1)

University of Missouri School of Medicine; 🇺🇸 Columbia, Missouri, United States