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

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Enrolling

Conditions

Insulin Resistance
Adiposity
Muscle Weakness
Obesity
Insulin Sensitivity

Treatments

Behavioral: Diet Weight Loss

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06129110
23-0545
1R01DK134706-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Generally healthy men and women aged 18-70

  • BMI between 30-40

  • Less than 1 hour of exercise per week

  • Women:

    1. 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:

    1. Currently going through menopause or peri-menopause
    2. Pregnant or breastfeeding
    3. History of Polycystic Ovary Syndrome

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Diet Weight Loss
Experimental group
Description:
Low calorie meal replacement shakes
Treatment:
Behavioral: Diet Weight Loss
Delayed Intervention
No Intervention group
Description:
Normal feeding

Trial contacts and locations

1

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Central trial contact

Bryan Bergman, PhD; Sophia Bowen

Data sourced from clinicaltrials.gov

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