Exercise Effects on Adipose Tissue Structure and Function

NCT ID: NCT04812314

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2030-03-01

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.

Detailed Description

Exercise is among the first line treatments for obesity and obesity-related diseases, yet it is shocking how little is known about how exercise works to improve health. Expanding the knowledge about novel exercise-induced adaptations in fat tissue of obese individuals and furthering the understanding about mechanisms underlying these adaptations could lead to innovative approaches for preventing and treating insulin resistance and obesity-related diseases.

Overall, the researchers believe that exercise training modifies key processes in subcutaneous fat tissue that may contribute to an increase body fat storage capacity (without increasing fat mass). The research team anticipates that exercise will evoke an even more potent adaptive response when fat tissue is dynamically changing in response to alterations in nutritional status (i.e., weight loss and weight regain).

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. After the participant completes the study, the study team will help the participant to lose more weight. Total involvement in the study for each participant will likely be about 8-10 months.

Conditions

Obesity; Metabolic Syndrome; Metabolic Disease; Insulin Resistance; Weight Loss; Weight Gain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

No exercise

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

Group Type: EXPERIMENTAL

No exercise

Intervention Type: BEHAVIORAL

Participants will remain sedentary throughout the duration of the study.

Interventions

Exercise

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

Intervention Type: BEHAVIORAL

No exercise

Participants will remain sedentary throughout the duration of the study.

Intervention Type: BEHAVIORAL

Other Intervention Names

Control group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey F Horowitz

professor of Movement Science and director of the Substrate Metabolism Laboratory (SML) at the University of Michigan School of Kinesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey F Horowitz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan, School of Kinesiology

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Suzette Howton

Role: CONTACT

smlstudies@umich.edu

734-647-9850

Facility Contacts

Jeffrey F Horowitz

Role: primary

jeffhoro@umich.edu

7346471076

Other Identifiers

HUM00175528

Identifier Type: -

Identifier Source: org_study_id