Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity

Part of paid clinical trials in Columbia, Missouri.

Sponsor
Bettina Mittendorfer
Study ID
NCT06335771
Status
Recruiting
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Conditions

  • Diabetes Type 2
  • Healthy
  • Nonalcoholic Fatty Liver
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Dietary consultation weight loss intervention — OTHER
    Participants will meet with a member of the study team biweekly for about 6 months.

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Jul 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • No Intervention: Lean Individuals
    No intervention will be administered.
  • Experimental: Metabolically abnormal obese Individuals (obesity with normoglycemia and abnormal liver fat content)
    Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.
  • Experimental: Metabolically normal obese Individuals (obesity with normoglycemia and normal liver fat content)
    Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.
  • Experimental: Individuals with Type 2 Diabetes Mellitus
    Participants will undergo a dietary weight loss intervention to achieve 10% weight loss over about 6 months.

Primary Outcome Measure

Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure. [ Time Frame: up to 6 months after the intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Missouri School of MedicineColumbiaMissouri65212
Bettina Mittendorfer
[email protected]
573-882-9377

Find similar trials in Columbia, MO

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Missouri School of Medicine· Columbia, MO

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