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Recruiting NCT06335771

Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity

No phase Interventional Obesity Nonalcoholic Fatty Liver Diabetes Type 2 Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dietary consultation weight loss intervention.
Who it may be relevant to
Registry conditions: Obesity, Nonalcoholic Fatty Liver, Diabetes Type 2, Healthy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity-Associated Diseases

Overview

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.

Interventions

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

Primary outcome measures

  • Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure. [Time frame: up to 6 months after the intervention]
  • 24-hour plasma glucose concentration [Time frame: up to 6 months after the intervention]
  • Macrophage isolation in adipose tissue biopsy [Time frame: up to 6 months after the intervention]
  • Macrophage isolation in skeletal muscle tissue [Time frame: up to 6 months after the intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Missouri School of Medicine — Columbia

Identifiers

NCT: NCT06335771 · 2098077 · R01DK131188

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗