Recruiting

Weight Loss

Sponsor:

University of Colorado, Denver

Code:

NCT06129110

Conditions

Obesity

Insulin Sensitivity

Muscle Weakness

Adiposity

Insulin Resistance

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Diet Weight Loss

Study Details

Brief summary:

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.

Conditions

Obesity

Insulin Sensitivity

Muscle Weakness

Adiposity

Insulin Resistance

Study ID

NCT06129110

Start date

Jan 31, 2024

Status verified date

May, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Diet Weight Loss

Low calorie meal replacement shakes

no intervention: Delayed Intervention

Normal feeding

Interventions

Diet Weight Loss

Low calorie diet of meal replacement shakes

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Bryan Bergman, PhD

3037243919bryan.bergman@cuanschutz.edu

Sophia Bowen

3037240487sophia.bowen@cuanschutz.edu

Locations

University of Colorado Anschutz

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Bryan Bergman, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • IMAT
  • Intermuscular Adipose Tissue
  • Weight Loss
  • Diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-05-15.