- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03414385
Effect of Exercise on Genes That Control Muscle Function
Epigenomic Remodeling of Metabolism by Exercise
Study Overview
Detailed Description
Exercise is a first-line treatment for type 2 diabetes, and exerts its beneficial effects not only by burning off energy but also by causing prolonged metabolic changes through changing gene expression. Genes are our genetic materials and the expression of genes determines our biology. In our previous study in animals, we identified some factors that drive exercise-induced gene expression changes. Here we would like to address whether the result is also true in human. This work will provide molecular insights into how exercise remodels our metabolism and will potentially find a way to maximize the benefit we get from physical exercise.
The purpose of this study is to determine whether acute exercise activate certain molecular factors in human skeletal muscle. Participants will be asked to undergo an acute bout of aerobic exercise at ~ moderate intensity for about 2 hours. Before and after the exercise, the participants will undergo a muscle biopsy. The muscle tissues will be used for total RNA extraction and RT-qPCR analysis of genes that include but are not limited to de facto JunD/AP-1 target genes and will also be analyzed by Jun D Chip-qPCT to assess binding of Jun D on its de facto target genes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Baylor College of Medicine/Michael E DeBakey VA Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 20 - 40 years
- BMI 18.5 - 29.9
- Stable body weight (not more than 2 kg change) during the past 6 months
- Moderate sedentary (regular exercise less than 1 hour per week for the last 6 months)
- Willing to provide informed consent
Exclusion Criteria:
- Failure to provide informed consent
- Any major chronic disease or any condition that would interfere with exercise, in which exercise is contraindicated, or that would interfere with interpretation of results
- Severe orthopedic and or neuromuscular disease that would contraindicate participation in exercise
- Other significant co-morbid disease that would impair ability to exercise
- Uncontrolled hypertension (BP greater than 160/90)
- History of malignancy during the past 5 years
- Diabetes mellitus as determined by self-report with verification (medical records, current treatment, confirmation from health care provider), or HbA1c of exceeding 6.5%
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise group
Research volunteers will be asked to undergo an acute bout of aerobic exercise at moderate intensity for ~120 minutes.
Before and after the exercise the volunteer will undergo leg biopsy.
|
Acute bout of aerobic exercise at moderate intensity for 2 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in JunD/AP-1 signaling in human skeletal muscle
Time Frame: Immediately after about 2 hours exercise
|
JunD/AP-target genes
|
Immediately after about 2 hours exercise
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Zheng Sun, PhD, Baylor College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-40366
- 1R01DK111436-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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