Weight Loss and Muscle Health Study

This study is looking at how weight loss affects the fat found within your muscles (intermuscular adipose tissue or IMAT) in people with obesity. Researchers want to understand how inflammatory molecules from IMAT contribute to muscle insulin resistance (when your body's cells don't respond well to insulin) and muscle weakness, and if these molecules decrease after losing weight. You could join if you are generally healthy, aged 18-70, have a BMI between 30-40, and exercise less than one hour per week. The study involves a 12-week low-calorie diet using meal replacement shakes. Success will be measured by changes in your insulin sensitivity, body weight, and the amount of IMAT after 12 weeks. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 70 participants. It will compare outcomes in individuals who lose weight to those who do not.
What's involved
You will have screening visits including body composition measures, blood tests, strength tests, and a thigh muscle biopsy. You will then follow a 12-week dietary intervention, followed by the same tests and biopsies.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks, with primary endpoints measured at that time.

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NCT06129110

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

Recruiting
NAAges 18–70InterventionalBasic science
University of Colorado, Denver
~70 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Diet Weight Loss

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insulin Sensitivity
Measured over 12 weeks
+4 more outcomes measured
Obesity
Insulin Sensitivity
Muscle Weakness
Adiposity
Insulin Resistance
1 sites across 1 states
Colorado1

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Eligibility criteria

Inclusion

Generally healthy men and women aged 18-70
BMI between 30-40
Less than 1 hour of exercise per week
Women:

Exclusion

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:
  • Insulin Sensitivity12 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.

  • Body Weight12 weeks

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

  • IMAT Content12 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.

  • Muscle Mass12 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.

  • Muscle Strength12 weeks

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