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Effect of Exercise on Genes That Control Muscle Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03414385
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : July 17, 2018
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
US Department of Veterans Affairs
Information provided by (Responsible Party):
Dennis T. Villareal, Baylor College of Medicine

Brief Summary:
The proposed project will examine how exercise counteracts metabolic disorders and type 2 diabetes through regulating gene expression. The project is highly relevant to public health because of the global pandemic of diabetes, obesity, and associated metabolic syndromes as well as the well-known metabolic benefit of physical exercise in correcting these disorders.

Condition or disease Intervention/treatment Phase
Healthy Other: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Epigenomic Remodeling of Metabolism by Exercise
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

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.
Other: Exercise
Acute bout of aerobic exercise at moderate intensity for 2 hours

Primary Outcome Measures :
  1. Change in JunD/AP-1 signaling in human skeletal muscle [ Time Frame: Immediately after about 2 hours exercise ]
    JunD/AP-target genes

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03414385

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Contact: Dennis Villareal, MD 713-794-7156
Contact: Zheng Sun, PhD 713-798-3164

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United States, Texas
Baylor College of Medicine/Michael E DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
US Department of Veterans Affairs
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Principal Investigator: Dennis T Villareal, MD Baylor College of Medicine
Principal Investigator: Zheng Sun, PhD Baylor College of Medicine

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Responsible Party: Dennis T. Villareal, Professor, Baylor College of Medicine Identifier: NCT03414385     History of Changes
Other Study ID Numbers: H-40366
1R01DK111436-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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