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Exercise Effects on Adipose Tissue Structure and Function (LG)

Primary Purpose

Obesity, Metabolic Syndrome, Metabolic Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
No exercise
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise

No exercise

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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..
Adipose Tissue Fibrosis
measured histologically using Sirus Red Staining, quantified using ImageJ software at each clinical visit appointment.
Muscle Capillarization
measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.
Adipose Capillarization
measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.
Fat Cell Size
measured histologically using Hematoxylin and eosin (H & E) staining, quantified using ImageJ software at each clinical visit appointment.

Secondary Outcome Measures

Blood Lipid Profile
A panel of blood tests that screens for abnormalities in blood lipids will be measured at each clinical visit appointment.
Blood Pressure
The pressure of circulating blood against the walls of blood vessels will be measured at screening and each clinical visit appointment.

Full Information

First Posted
March 19, 2021
Last Updated
June 15, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04812314
Brief Title
Exercise Effects on Adipose Tissue Structure and Function
Acronym
LG
Official Title
Exercise Effects on Adipose Tissue Structure and Function
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
March 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome, Metabolic Disease, Insulin Resistance, Weight Loss, Weight Gain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
No exercise
Arm Type
Experimental
Arm Description
Subjects assigned to this group are to remain sedentary (no planned physical exercise) throughout the duration of the study.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Participants will complete a moderate intensity continuous exercise 4 days/week.
Intervention Type
Behavioral
Intervention Name(s)
No exercise
Other Intervention Name(s)
Control group
Intervention Description
Participants will remain sedentary throughout the duration of the study.
Primary Outcome Measure Information:
Title
Oral Glucose Tolerance Test (OGTT)
Description
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..
Time Frame
2 hours
Title
Adipose Tissue Fibrosis
Description
measured histologically using Sirus Red Staining, quantified using ImageJ software at each clinical visit appointment.
Time Frame
30 minutes
Title
Muscle Capillarization
Description
measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.
Time Frame
30 minutes
Title
Adipose Capillarization
Description
measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.
Time Frame
30 minutes
Title
Fat Cell Size
Description
measured histologically using Hematoxylin and eosin (H & E) staining, quantified using ImageJ software at each clinical visit appointment.
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
Blood Lipid Profile
Description
A panel of blood tests that screens for abnormalities in blood lipids will be measured at each clinical visit appointment.
Time Frame
15 minutes
Title
Blood Pressure
Description
The pressure of circulating blood against the walls of blood vessels will be measured at screening and each clinical visit appointment.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzette Howton
Phone
734-647-9850
Email
smlstudies@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey F Horowitz, PhD
Organizational Affiliation
University of Michigan, School of Kinesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey F Horowitz
Phone
734-647-1076
Email
jeffhoro@umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

Exercise Effects on Adipose Tissue Structure and Function

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