Metabolic Adaptations to Weight Loss With and Without Exercise
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- University of Michigan
- Study ID
- NCT05806801
- Status
- Recruiting
Conditions
- Insulin Resistance
- Insulin Sensitivity
- Metabolic Disease
- Metabolic Syndrome
- Obesity
- Weight Loss
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 40 Years
- Healthy Volunteers
- Accepted
Interventions
- MICT Exercise — BEHAVIORALSubjects randomized into this group will complete a moderate intensity continuous exercise 4 days/week.
- No Exercise (Control) — BEHAVIORALSubjects randomized into this group will remain sedentary throughout the duration of the study.
Study Details
Study Purpose: The combination of caloric restriction and exercise is the most common first-line treatment for obesity-related disorders, yet we know very little about how these two very different treatments work together. A deeper understanding about mechanisms underlying the health benefits of adding exercise to a weight loss program will not only aid efforts to optimize more effective lifestyle interventions, but it can also uncover novel targets for the treatment/prevention of obesity-related diseases. Although a reduction in body fat is the fundamental adaptation to weight loss, we know almost nothing about the effects that adding exercise has on structural and functional changes within fat tissue that may further enhance metabolic health. This is very important because many obesity-related metabolic health complications are tightly linked with abnormalities in abdominal fat tissue. We argue exercise-induced modifications in abdominal fat tissue will reveal persistent health benefits even if some weight is regained Study Summary: 10% Weight Loss Phase - Subject participation in the study will involve a series of metabolic tests before, at midpoint, and after undergoing a 10% weight loss program (with or without exercise training depending on group randomization). During this, subjects will be randomized into one of two different experimental groups: 1. Moderate Intensity Continuous Training (MICT) exercise group 2. No exercise (control) group Follow-up Phase: After completing the metabolic testing post-weight loss, all study-related diet and exercise supervision will end and subjects will be free to make their own choices regarding diet and exercise/physical activity behavior. Subjects will then be asked to complete follow-up testing at 2-, 4- and 6- months post-weight loss. Total involvement in the study for each subject will likely be about 10-13 months (4-7 months during weight loss phase, 6 months during follow-up phase).
Key Dates
- Start date
- Jul 19, 2023
- Status verified
- Apr 2026
- Primary completion
- Aug 1, 2027
- Completion
- May 31, 2028
Study Design
- Enrollment
- 68 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Moderate Intensity Continuous Training (MICT) exercise group45 minutes of continuous steady-state exercise at 70% maximal heart rate throughout the 10% weight loss phase of the study
- Experimental: No exercise (Control)to remain sedentary (no planned physical exercise) throughout the duration of the 10% weight loss phase of the study
Primary Outcome Measure
Insulin sensitivity [ Time Frame: 2 hours ]
Central Contacts
- Suzette M Howton734-647-9850
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | Jeff F Horowitz, PhD (PRINCIPAL_INVESTIGATOR) |
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