LG: Exercise Effects on Adipose Tissue Structure and Function

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT04812314
Collaborator
(none)
46
1
2
108
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise
  • Behavioral: No exercise
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Exercise Effects on Adipose Tissue Structure and Function
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2030

Arms and Interventions

Arm Intervention/Treatment
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.

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

Experimental: No exercise

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

Behavioral: No exercise
Participants will remain sedentary throughout the duration of the study.
Other Names:
  • Control group
  • Outcome Measures

    Primary Outcome Measures

    1. Oral Glucose Tolerance Test (OGTT) [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 [30 minutes]

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

    3. Muscle Capillarization [30 minutes]

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

    4. Adipose Capillarization [30 minutes]

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

    5. Fat Cell Size [3 minutes]

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

    Secondary Outcome Measures

    1. Blood Lipid Profile [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 [10 minutes]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age: 18-40

    • Body Mass Index: 30-45 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan

    Investigators

    • Principal Investigator: Jeffrey F Horowitz, PhD, University of Michigan, School of Kinesiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT04812314
    Other Study ID Numbers:
    • HUM00175528
    First Posted:
    Mar 23, 2021
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 11, 2022