Recruiting

Weight Loss & Exercise

Sponsor:

University of Michigan

Code:

NCT05806801

Conditions

Obesity

Metabolic Disease

Metabolic Syndrome

Insulin Sensitivity

Insulin Resistance

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

MICT Exercise

No Exercise (Control)

Study Details

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).

Conditions

Obesity

Metabolic Disease

Metabolic Syndrome

Insulin Sensitivity

Insulin Resistance

Study ID

NCT05806801

Start date

Jul 19, 2023

Status verified date

Apr, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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 Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Moderate Intensity Continuous Training (MICT) exercise group

45 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

Interventions

MICT Exercise

Subjects randomized into this group will complete a moderate intensity continuous exercise 4 days/week.

No Exercise (Control)

Subjects randomized into this group will remain sedentary throughout the duration of the study.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Suzette M Howton

734-647-9850suzetter@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Suzette Howton

7346479850suzetter@med.umich.edu

Principal Investigator:

Jeff F Horowitz, PhD

More Information

Sponsor

University of Michigan

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-04-14.