Metabolic Adaptations to Weight Loss With and Without Exercise
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MICT Exercise, No Exercise (Control).
- Who it may be relevant to
- Registry conditions: Obesity, Metabolic Disease, Metabolic Syndrome, Insulin Sensitivity. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Behavioral MICT Exercise
Subjects randomized into this group will complete a moderate intensity continuous exercise 4 days/week. - Behavioral No Exercise (Control)
Subjects randomized into this group will remain sedentary throughout the duration of the study.
Primary outcome measures
- Insulin sensitivity [Time frame: 2 hours]
- Fatty acid turnover [Time frame: 2 hours]
- Adipose tissue capillarization [Time frame: 30 minutes]
- Adipose tissue fibrosis [Time frame: 30 minutes]
Secondary outcome measures (3)
- Body weight change [Time frame: 6 months]
- Body fat mass [Time frame: 30 minutes]
- Oral Glucose Tolerance Test (OGTT) [Time frame: 2 hours]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT05806801 · HUM00220220