Effect of Weight Loss on Intermuscular Adipose Tissue (IMAT) Signaling
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Body Weight
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- 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
- •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
- •Currently going through menopause or peri-menopause
- •Pregnant or breastfeeding
- •History of Polycystic Ovary Syndrome
Arms & Interventions
Diet Weight Loss
Low calorie meal replacement shakes
Intervention: Diet Weight Loss (Behavioral)
Delayed Intervention
Normal feeding
Outcomes
Primary Outcomes
Body Weight
Time Frame: 12 weeks
Participant weight will be measured using BodyTrace scales during the 12 week intervention.
Insulin Sensitivity
Time Frame: 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.
IMAT Content
Time Frame: 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.
Muscle Strength
Time Frame: 12 weeks
Participants will perform quadriceps muscle strength testing using an isokinetic dynamometer.
Muscle Mass
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported