Metabolic Adaptations to Chronic and Acute Exercise in Overweight Adults (ATX-Study) (ATX)
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise session
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
Eligibility Criteria
Inclusion Criteria:
- Age: 18-40
- Body Mass Index: 25-35 kg/m2
- Regular exercisers: (≥4 days/wk of aerobic exercise; 30-60min/session at moderate and vigorous intensities)
- Non-exercisers: no regularly planned exercise/physical activity
- Women must have regularly occurring menses and must be premenopausal
Exclusion Criteria:
- Blood pressure > 140/90 mm Hg
- Pregnant or lactating
- Evidence/history of cardiovascular or metabolic disease
- Medications known to affect lipid or glucose metabolism
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Exercise session
Arm Description
Subjects will exercise at a moderate intensity for 60 minutes. There are no different arms in this study.
Outcomes
Primary Outcome Measures
PPARg mRNA expression
The study team will quantify the abundance of key adipogenic markers in adipose tissue biopsy samples
Cytokine abundance in adipose tissue
The study team will measure cytokine proteins in adipose tissue
Secondary Outcome Measures
Total Cholesterol
Plasma concentrations of total- cholesterol will be measured.
Full Information
NCT ID
NCT02701751
First Posted
January 21, 2016
Last Updated
March 18, 2022
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT02701751
Brief Title
Metabolic Adaptations to Chronic and Acute Exercise in Overweight Adults (ATX-Study)
Acronym
ATX
Official Title
Metabolic Adaptations to Chronic and Acute Exercise in Overweight Adults (ATX-Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 24, 2016 (Actual)
Study Completion Date
October 24, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to examine the effects of chronic exercise training and an acute session of exercise on key risk factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile, and blood pressure) and alterations in subcutaneous adipose tissue structure and metabolic function in overweight adults.
Detailed Description
Subjects will be asked to complete the Substrate Metabolism Laboratory General Screening Questionnaire and American Heart Association Health/Fitness Questionnaire to determine if they are eligible to complete the preliminary testing procedures. If eligible, subjects will be asked to visit the Substrate Metabolism Laboratory to participate in the preliminary testing procedures (listed below) before participating in the experimental trial.
PRELIMINARY TESTING PROCEDURES:
Blood pressure, height and weight measurements
Body Composition Assessment (~20 min)
Exercise Fitness Test (~10 min)
Resting Metabolic Rate (RMR) measurement (~30 min)
3 hour Oral Glucose Tolerance Test (OGTT)
EXPERIMENTAL TRIAL:
The evening before the experimental trial, subjects will eat a standardized dinner meal and snack. The meal and snack must be eaten at specific times as indicated by the research staff. After eating the snack, subjects will need to fast (no food or beverages - besides water) overnight.
Participants who exercise regularly will be instructed to exercise exactly 3 days before the experimental trial, and then abstain from their exercise training program until after the study is complete.
In the morning, subjects will return to the Substrate Metabolism Laboratory. The research team will collect a blood sample from the subject's hand or forearm and a small sample of fat tissue in the subject's abdomen with a needle. Next, subjects will exercise on a treadmill at a moderate intensity for about 1 hour. Immediately after exercising the research team will collect a second blood sample. Subjects will remain in the laboratory for 1 hour after exercising, and then the research team will collect another blood and fat tissue sample. Upon completion of the experimental trial, subjects will be provided a snack before leaving the laboratory.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
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
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise session
Arm Type
Other
Arm Description
Subjects will exercise at a moderate intensity for 60 minutes. There are no different arms in this study.
Intervention Type
Other
Intervention Name(s)
Exercise session
Intervention Description
A blood sample and fat biopsy will be obtained before and after the 60 minute moderate exercise session. There is no drug or device intervention in this study.
Primary Outcome Measure Information:
Title
PPARg mRNA expression
Description
The study team will quantify the abundance of key adipogenic markers in adipose tissue biopsy samples
Time Frame
change from baseline at 1 hour post exercise
Title
Cytokine abundance in adipose tissue
Description
The study team will measure cytokine proteins in adipose tissue
Time Frame
change from baseline at 1 hour post exercise
Secondary Outcome Measure Information:
Title
Total Cholesterol
Description
Plasma concentrations of total- cholesterol will be measured.
Time Frame
change from baseline at 1 hour post exercise
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
Body Mass Index: 25-35 kg/m2
Regular exercisers: (≥4 days/wk of aerobic exercise; 30-60min/session at moderate and vigorous intensities)
Non-exercisers: no regularly planned exercise/physical activity
Women must have regularly occurring menses and must be premenopausal
Exclusion Criteria:
Blood pressure > 140/90 mm Hg
Pregnant or lactating
Evidence/history of cardiovascular or metabolic disease
Medications known to affect lipid or glucose metabolism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey F Horowitz
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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Metabolic Adaptations to Chronic and Acute Exercise in Overweight Adults (ATX-Study)
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