Health TrialsbyHealthPanel

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

ConditionsObesityInsulin SensitivityMuscle WeaknessAdiposityInsulin Resistance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Generally healthy men and women aged 18-70

BMI between 30-40

Less than 1 hour of exercise per week

may be pre or post menopausal

Disqualifiers

Type 1 or Type 2 diabetes

Thyroid disease

History of lung disease

Active use of nicotine

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diet Weight Loss

    Behavioral

    Low calorie diet of meal replacement shakes

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Diet Weight LossExperimental treatment 1 intervention
Group B: Delayed InterventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Insulin Sensitivity

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.

Time frame
12 weeks
2

Body Weight

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

Time frame
12 weeks
3

IMAT Content

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.

Time frame
12 weeks
4

Muscle Mass

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.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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