Clinical trial NCT03414385: Effect of Exercise on Genes That Control Muscle Function
Official title: Epigenomic Remodeling of Metabolism by Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: US Department of Veterans Affairs
First posted: 2018-01-29
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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%

Primary outcomes:
measure: Change in JunD/AP-1 signaling in human skeletal muscle
timeFrame: Immediately after about 2 hours exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine/Michael E DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Dennis T Villareal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Zheng Sun, PhD
role: PRINCIPAL_INVESTIGATOR
References: