NCT05806801 Metabolic Adaptations to Weight Loss With and Without Exercise
| NCT ID | NCT05806801 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2023-07-19 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2023-07-19 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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.
Contact & Investigator
Jeffrey Horowitz, PhD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT05806801 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05806801 currently recruiting?
Yes, NCT05806801 is actively recruiting participants. Contact the research team at suzetter@med.umich.edu for enrollment information.
Where is the NCT05806801 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT05806801 clinical trial?
NCT05806801 is sponsored by University of Michigan. The principal investigator is Jeffrey Horowitz, PhD at University of Michigan. The trial plans to enroll 68 participants.
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