Back to resultsComparing the Effects of Exercise on the Structure and Function of Fat Tissue (CAT)
Primary Purpose
Adiposity
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral Glucose Tolerance Test
Sponsored by
About this trial
This is an interventional basic science trial for Adiposity
Eligibility Criteria
Inclusion Criteria:
- Age: 18-40 years old
- Body Mass Index: 23-35 kg/m2
- 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 6 months
- Tobacco or e-cigarette users
- Women must not be pregnant or actively lactating
- Blood pressure > 140/90 mmHg
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oral Glucose Tolerance Test
Arm Description
Subjects will complete an Oral Glucose Tolerance Test in which glucose is given and blood samples are taken every 15 minutes over a 2 hour period to determine how quickly the glucose is cleared from the blood.
Outcomes
Primary Outcome Measures
Blood Glucose Level
mg/dL
Adipose tissue fibrosis
Pico-sirius Red stain (percent stained)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05328570
Brief Title
Comparing the Effects of Exercise on the Structure and Function of Fat Tissue
Acronym
CAT
Official Title
Effects of Exercise Training on the Structure and Metabolic Function of Fat Tissue
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 4, 2020 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (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
Assess differences in structure and biological function of abdominal subcutaneous adipose tissue samples collected from adults who exercise regularly vs. a well-matched cohort of non-exercisers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adiposity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral Glucose Tolerance Test
Arm Type
Experimental
Arm Description
Subjects will complete an Oral Glucose Tolerance Test in which glucose is given and blood samples are taken every 15 minutes over a 2 hour period to determine how quickly the glucose is cleared from the blood.
Intervention Type
Diagnostic Test
Intervention Name(s)
Oral Glucose Tolerance Test
Intervention Description
Subjects will complete an Oral Glucose Tolerance Test in which glucose is given and blood samples are taken every 15 minutes over a 2 hour period to determine how quickly the glucose is cleared from the blood.
Primary Outcome Measure Information:
Title
Blood Glucose Level
Description
mg/dL
Time Frame
2 hours at Experimental Trial
Title
Adipose tissue fibrosis
Description
Pico-sirius Red stain (percent stained)
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: 18-40 years old
Body Mass Index: 23-35 kg/m2
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 6 months
Tobacco or e-cigarette users
Women must not be pregnant or actively lactating
Blood pressure > 140/90 mmHg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey F Horowitz, PhD
Organizational Affiliation
University of Michigan
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
12. IPD Sharing Statement
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Comparing the Effects of Exercise on the Structure and Function of Fat Tissue
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