Recruiting

Exercise Effects

Sponsor:

University of Michigan

Code:

NCT04812314

Conditions

Obesity

Metabolic Syndrome

Metabolic Disease

Insulin Resistance

Weight Loss

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Exercise

No exercise

Study Details

Brief summary:

Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.

Conditions

Obesity

Metabolic Syndrome

Metabolic Disease

Insulin Resistance

Weight Loss

Study ID

NCT04812314

Start date

Mar 1, 2021

Status verified date

Jun, 2026

Completion date

Mar 1, 2030

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age: 18-40
  • Body Mass Index: 27-45 kg/m2
  • No regularly planned exercise/physical activity for at least 6 months
  • Women must have regularly occurring menses and must be premenopausal

Exclusion Criteria:

  • Evidence/history of cardiovascular or metabolic disease
  • Medications known to affect lipid or glucose metabolism, or inflammation
  • Weight instability ≥ ± 6 pounds in the last 3 months
  • Tobacco or e-cigarette users
  • Women must not be pregnant or actively lactating

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Exercise

This exercise prescription represents a common or "conventional" form of physical activity (e.g., moderate/brisk walking). If assigned to this group, participants will perform 45 minutes of moderate intensity continuous steady-state exercise at 70% maximal heart rate (HRmax) to expend 250 calories 4 days per week.

experimental: No exercise

Subjects assigned to this group are to remain sedentary (no planned physical exercise) throughout the duration of the study.

Interventions

Exercise

Participants will complete a moderate intensity continuous exercise 4 days/week.

No exercise

Participants will remain sedentary throughout the duration of the study.

Primary outcome measure

  • Oral Glucose Tolerance Test (OGTT) [ Time Frame: 2 hours ]
  • Adipose Tissue Fibrosis [ Time Frame: 30 minutes ]
  • Muscle Capillarization [ Time Frame: 30 minutes ]
  • Adipose Capillarization [ Time Frame: 30 minutes ]
  • Fat Cell Size [ Time Frame: 3 minutes ]

Central Contacts and Locations

Central contacts

Suzette Howton

734-647-9850smlstudies@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Jeffrey F Horowitz

7346471076jeffhoro@umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-06-04.