- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02701751
Metabolic Adaptations to Chronic and Acute Exercise in Overweight Adults (ATX-Study) (ATX)
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Exercise session
Subjects will exercise at a moderate intensity for 60 minutes.
There are no different arms in this study.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PPARg mRNA expression
Time Frame: change from baseline at 1 hour post exercise
|
The study team will quantify the abundance of key adipogenic markers in adipose tissue biopsy samples
|
change from baseline at 1 hour post exercise
|
|
Cytokine abundance in adipose tissue
Time Frame: change from baseline at 1 hour post exercise
|
The study team will measure cytokine proteins in adipose tissue
|
change from baseline at 1 hour post exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Cholesterol
Time Frame: change from baseline at 1 hour post exercise
|
Plasma concentrations of total- cholesterol will be measured.
|
change from baseline at 1 hour post exercise
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00102522
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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