Effect of Exercise on Genes That Control Muscle Function
Epigenomic Remodeling of Metabolism by Exercise
2 other identifiers
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Feb 2018
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2018
CompletedFirst Posted
Study publicly available on registry
January 29, 2018
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedMarch 23, 2023
March 1, 2023
1.9 years
January 17, 2018
March 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in JunD/AP-1 signaling in human skeletal muscle
JunD/AP-target genes
Immediately after about 2 hours exercise
Study Arms (1)
Exercise group
EXPERIMENTALResearch 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor College of Medicine/Michael E DeBakey VA Medical Center
Houston, Texas, 77030, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis T Villareal, MD
Baylor College of Medicine
- PRINCIPAL INVESTIGATOR
Zheng Sun, PhD
Baylor College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 17, 2018
First Posted
January 29, 2018
Study Start
February 1, 2018
Primary Completion
December 31, 2019
Study Completion
May 31, 2022
Last Updated
March 23, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share