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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06129110
Collaborator
National Institutes of Health (NIH) (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
70
2
71

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Diet Weight Loss
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effect of Weight Loss on Intermuscular Adipose Tissue (IMAT) Signaling
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Dec 1, 2028
Anticipated Study Completion Date :
Dec 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diet Weight Loss

Low calorie meal replacement shakes

Behavioral: Diet Weight Loss
Low calorie diet of meal replacement shakes

No Intervention: Delayed Intervention

Normal feeding

Outcome Measures

Primary Outcome Measures

  1. Insulin Sensitivity [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 [12 weeks]

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

  3. IMAT Content [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 [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 [12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT06129110
Other Study ID Numbers:
  • 23-0545
  • 1R01DK134706-01A1
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Colorado, Denver
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023