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NCT Number: NCT04812314

Exercise Effects on Adipose Tissue Structure and Function

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.

Recruiting

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Jeffrey F Horowitz

CONTACT

[email protected]

7346471076

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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

No exercise

Behavioral

Participants will remain sedentary throughout the duration of the study.

Other names: Control group

Primary outcomes

  1. Oral Glucose Tolerance Test (OGTT)

    Time frame: 2 hours

    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. Adipose Tissue Fibrosis

    Time frame: 30 minutes

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

  3. Muscle Capillarization

    Time frame: 30 minutes

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

  4. Adipose Capillarization

    Time frame: 30 minutes

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

  5. Fat Cell Size

    Time frame: 3 minutes

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

Secondary outcomes

  1. Blood Lipid Profile

    Time frame: 15 minutes

    A panel of blood tests that screens for abnormalities in blood lipids will be measured at each clinical visit appointment.

  2. Blood Pressure

    Time frame: 10 minutes

    The pressure of circulating blood against the walls of blood vessels will be measured at screening and each clinical visit appointment.

Study contacts

Contact information is provided by the study sponsor or research team.

Suzette Howton

CONTACT

[email protected]

734-647-9850

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: LG

Important dates

Study start
2021
Primary completion
2028
Study completion
2030
First posted
Mar 23, 2021
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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