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NCT Number: NCT06129110

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

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.

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Key information

Conditions

Obesity Adiposity Body Weight Body Weight Changes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Metabolic Diseases Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Bryan Bergman, PhD

CONTACT

Bryan Bergman, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet Weight Loss

Behavioral

Low calorie diet of meal replacement shakes

Primary outcomes

  1. Insulin Sensitivity

    Time frame: 12 weeks

    Participants will undergo a standard 3-hour hyperinsulinemic/euglycemic clamp with insulin infused at 80 mU/m2/min, and glucose clamped at 90 mg/dl with a variable dextrose infusion.

  2. Body Weight

    Time frame: 12 weeks

    Participant weight will be measured using BodyTrace scales during the 12 week intervention.

  3. IMAT Content

    Time frame: 12 weeks

    A multi-slice MRI will be used to quantify IMAT and muscle content in both legs with acquisition of ~20 axial images (10 mm thickness) with 10 mm spacing between images starting superior to the patella. IMAT content will be quantified using the well-validated Sirlin 6-echo method and normalized to muscle volume.

  4. Muscle Mass

    Time frame: 12 weeks

    A multi-slice MRI will be used to quantify IMAT and muscle content in both legs with acquisition of ~20 axial images (10 mm thickness) with 10 mm spacing between images starting superior to the patella. Muscle volume will be quantified using standard methods with anatomical cross-sectional area evaluated in each T1 weighted, high resolution, gradient echo profile scan, and multiplied by the length of the muscle.

  5. Muscle Strength

    Time frame: 12 weeks

    Participants will perform quadriceps muscle strength testing using an isokinetic dynamometer.

Study contacts

Contact information is provided by the study sponsor or research team.

Bryan Bergman, PhD

CONTACT

[email protected]

3037243919

Sophia Bowen

CONTACT

[email protected]

3037240487

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 13, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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