Exercise Effects on Adipose Tissue Structure and Function

NCT04812314 | Recruiting

• 1 other identifier: HUM00175528
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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; Weight Gain

Outcome Measures

Primary Outcomes (5)

• Oral Glucose Tolerance Test (OGTT)

  A test in which glucose is given and blood samples taken afterward to determine how quickly it is cleared from the blood will be completed at each clinical visit appointment..

  2 hours

• Adipose Tissue Fibrosis

  measured histologically using Sirus Red Staining, quantified using ImageJ software at each clinical visit appointment.

  30 minutes

• Muscle Capillarization

  measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.

  30 minutes

• Adipose Capillarization

  measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.

  30 minutes

• Fat Cell Size

  measured histologically using Hematoxylin and eosin (H \& E) staining, quantified using ImageJ software at each clinical visit appointment.

  3 minutes

Secondary Outcomes (2)

• Blood Lipid Profile

  15 minutes

• Blood Pressure

  10 minutes

Study Arms (2)

Exercise

EXPERIMENTAL

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.

Behavioral: Exercise

No exercise

EXPERIMENTAL

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

Behavioral: No exercise

Interventions

Exercise BEHAVIORAL

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

Exercise

No exercise BEHAVIORAL

Participants will remain sedentary throughout the duration of the study.

Also known as: Control group

No exercise

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

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

Interventions

Exercise; Control Groups

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Body Weight Changes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jeffrey F Horowitz, PhD

  University of Michigan, School of Kinesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzette Howton

CONTACT

734-647-9850; smlstudies@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of Movement Science and director of the Substrate Metabolism Laboratory (SML) at the University of Michigan School of Kinesiology

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2030
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)