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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06129110
Enrollment
70
Registered
2023-11-13
Start date
2024-01-31
Completion date
2028-09-01
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adiposity, Insulin Resistance, Insulin Sensitivity, Muscle Weakness, Obesity

Keywords

IMAT, Intermuscular Adipose Tissue, Weight Loss, Diet

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.

Interventions

Low calorie diet of meal replacement shakes

Sponsors

University of Colorado, Denver
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Insulin Sensitivity12 weeksParticipants 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 weeksParticipant weight will be measured using BodyTrace scales during the 12 week intervention.
IMAT Content12 weeksA 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 weeksA 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 weeksParticipants will perform quadriceps muscle strength testing using an isokinetic dynamometer.

Countries

United States

Contacts

CONTACTBryan Bergman, PhD
bryan.bergman@cuanschutz.edu3037243919
CONTACTSophia Bowen
sophia.bowen@cuanschutz.edu3037240487

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026