Effects of weight loss with and without exercise on metabolic health
Metabolic Adaptations to Weight Loss With and Without Exercise
This study is testing whether losing weight with exercise helps improve metabolic health more than just losing weight through dieting alone for people with obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05806801 on ClinicalTrials.gov |
What this trial studies
This study investigates how combining caloric restriction with exercise influences metabolic health in individuals with obesity. It aims to understand the mechanisms behind the health benefits of exercise during weight loss, particularly focusing on changes in abdominal fat tissue. Participants will be assigned to either a moderate-intensity continuous training exercise group or a control group with no exercise, allowing researchers to compare the effects of these interventions on metabolic adaptations. The findings could lead to more effective lifestyle interventions for obesity-related disorders.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-40 with a BMI between 30-40 kg/m2 who are weight stable and do not engage in regular exercise.
Not a fit: Patients with cardiovascular disease, diabetes, or other metabolic diseases, as well as those on medications affecting metabolism, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that enhance the effectiveness of weight loss programs and improve metabolic health outcomes for patients with obesity.
How similar studies have performed: Other studies have shown that combining exercise with caloric restriction can lead to improved metabolic outcomes, suggesting this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Age: 18-40 * Body Mass Index: 30-40 kg/m2 * Weight stable (±3kg for greater than or equal to about 2 months) * No regularly planned exercise/physical activity * Women must have regularly occurring menses and must be premenopausal Exclusion criteria * EKG abnormalities * Evidence/history of cardiovascular disease, diabetes or other metabolic disease * Medications known to affect lipid or glucose metabolism * Pregnant or lactating * Tobacco or e-cigarette use * Prior experience of hypersensitivity to insulin, human albumin, and potassium chloride injection. * Allergies/hypersensitivity to local anesthetics of the amide type (e.g., lidocaine) * History of hyperkalemia or potential for developing hyperkalemia (including but not limited to taking drugs that may induce hyperkalemia such as cardiac glycosides or potassium sparing diuretics) * Anti-coagulant medication (e.g., Coumadin, Rivaroxaban) and Lidocaine allergy/sensitivity are exclusion criteria for the biopsy procedure.
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Horowitz, PhD — University of Michigan
- Study coordinator: Suzette M Howton
- Email: suzetter@med.umich.edu
- Phone: 734-647-9850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.