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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129110
• Other study ID #: 23-0545
• Secondary ID: 1R01DK134706-01A
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 1, 2029

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: Bryan Bergman, PhD
• Phone: 3037243919
• Email: bryan.bergman[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 1, 2029
• Est. primary completion date: December 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Insulin Resistance
• Insulin Sensitivity
• Muscle Weakness
• Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Anschutz	Aurora	Colorado

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Primary	Body Weight	Participant weight will be measured using BodyTrace scales during the 12 week intervention.	12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	Muscle Strength	Participants will perform quadriceps muscle strength testing using an isokinetic dynamometer.	12 weeks