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Recruiting NCT06129110

Effect of Weight Loss on Intermuscular Adipose Tissue (IMAT) Signaling

No phase Interventional Obesity Insulin Sensitivity Muscle Weakness Adiposity

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: Diet Weight Loss.
Who it may be relevant to
Registry conditions: Obesity, Insulin Sensitivity, Muscle Weakness, Adiposity. 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 →

Overview

The goal of this intervention study is to learn about how weight loss impacts molecular signaling of intermuscular adipose tissue (IMAT) in individuals with obesity. The main question it aims to answer is how inflammatory molecules secreted by IMAT promote muscle insulin resistance and inflammation, and how these same molecules are diminished after weight loss. Following screening visits involving body composition measures, blood testing, strength testing, and a thigh muscle biopsy, participants will go through a 12-week dietary intervention for weight loss. After 12 weeks, this will be followed by the same testing and biopsies that were completed before the intervention. Researchers will then compare outcomes of individuals who lost weight to individuals who did not lose weight.

Interventions

  • Behavioral Diet Weight Loss
    Low calorie diet of meal replacement shakes

Primary outcome measures

  • Insulin Sensitivity [Time frame: 12 weeks]
  • Body Weight [Time frame: 12 weeks]
  • IMAT Content [Time frame: 12 weeks]
  • Muscle Mass [Time frame: 12 weeks]
  • Muscle Strength [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • Generally healthy men and women aged 18-70
  • BMI between 30-40
  • Less than 1 hour of exercise per week
  • Women:
  • may be pre or post menopausal

Exclusion criteria

  • Type 1 or Type 2 diabetes
  • Thyroid disease
  • History of lung disease
  • Active use of nicotine
  • Severe plasma lipid disorders
  • Taking hormone replacement drugs, blood thinners, or thiazoladinediones
  • Women:
  • Currently going through menopause or peri-menopause
  • Pregnant or breastfeeding
  • History of Polycystic Ovary Syndrome

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

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Colorado Anschutz — Aurora

Identifiers

NCT: NCT06129110 · 23-0545 · 1R01DK134706-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗