Metabolic Adaptations to Weight Loss With and Without Exercise
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 40 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how losing 10% of body weight, with or without exercise, changes belly fat and how the body uses energy. It is for adults ages 18–40 with obesity who do not exercise regularly. Participants are assigned by chance to an exercise or no-exercise group, and the study lasts about 10–13 months.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18–40.
- Body mass index (BMI), a measure of weight compared to height, of 30–40.
- Weight has stayed within about 3 kilograms (6.6 pounds) for at least about 2 months.
- No regularly planned exercise or physical activity.
- Women must have regular periods and must not have reached menopause.
Who can't join
- Abnormal results on an EKG, a test of the heart’s electrical activity.
- Signs or a history of heart or blood vessel disease, diabetes, or another disease affecting how the body uses energy.
- Taking medicines known to affect how the body handles fats or sugar.
- Pregnant or breastfeeding.
- Using tobacco or e-cigarettes.
- Past allergic or sensitivity reactions to insulin, human albumin, potassium chloride injections, or amide-type numbing medicines such as lidocaine.
- A history of high blood potassium, or a risk of developing it, including from certain medicines.
- For the biopsy (taking a small tissue sample): taking blood thinners such as Coumadin or rivaroxaban, or having a lidocaine allergy or sensitivity.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
MI
- University of Michigan · Ann Arbor, MI 48109Suzette Howton · Study contact · 7346479850 · suzetter@med.umich.eduJeff F Horowitz, PhD · Principal investigatorMore trials in Ann Arbor