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Exercise Effects on Adipose Tissue Structure and Function (LG)

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ClinicalTrials.gov Identifier: NCT04812314
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Jeffrey F Horowitz, University of Michigan

Study Description
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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
Obesity Metabolic Syndrome Metabolic Disease Insulin Resistance Weight Loss Weight Gain Behavioral: Exercise Behavioral: No exercise Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 1, 2021
Estimated Primary Completion Date : March 1, 2026
Estimated Study Completion Date : March 1, 2030
Arms and Interventions
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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 Name: Control group


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04812314


Contacts
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Contact: Suzette Howton 734-647-9850 smlstudies@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jeffrey F Horowitz    734-647-1076    jeffhoro@umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Jeffrey F Horowitz, PhD University of Michigan, School of Kinesiology
More Information
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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: March 23, 2021    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Metabolic Diseases
Body Weight
Weight Loss
 Weight Gain
Body Weight Changes
Hyperinsulinism
Glucose Metabolism Disorders