Effect of Exercise on Genes That Control Muscle Function

Sponsor

Baylor College of Medicine (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03414385

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), US Department of Veterans Affairs (U.S. Fed)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Epigenomic Remodeling of Metabolism by Exercise

Actual Study Start Date :

Feb 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in JunD/AP-1 signaling in human skeletal muscle [Immediately after about 2 hours exercise]
JunD/AP-target genes

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

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%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baylor College of Medicine/Michael E DeBakey VA Medical Center	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

Investigators

Principal Investigator: Dennis T Villareal, MD, Baylor College of Medicine
Principal Investigator: Zheng Sun, PhD, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dennis T. Villareal, Professor, Baylor College of Medicine

ClinicalTrials.gov Identifier:

NCT03414385

Other Study ID Numbers:

H-40366
1R01DK111436-01A1

First Posted:

Jan 29, 2018

Last Update Posted:

Feb 22, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 22, 2022