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CompletedNCT03414385Updated Mar 23, 2023

Effect of Exercise on Genes That Control Muscle Function

An interventional study of Exercise in Healthy, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-23.

Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 111 are open to participants now.

Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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%
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • 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

Interventions

  • OtherExercise

    Acute bout of aerobic exercise at moderate intensity for 2 hours

06

What researchers measure

Primary outcomes

  1. Change in JunD/AP-1 signaling in human skeletal muscle

    JunD/AP-target genes

    Time frame: Immediately after about 2 hours exercise

07

Study locations

1 site
  • Baylor College of Medicine/Michael E DeBakey VA Medical Center
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Dec 2019, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2018
First posted
Jan 29, 2018
StartActual
Feb 1, 2018
Primary completionActual
Dec 31, 2019
CompletionActual
May 31, 2022
Last update
Mar 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03414385
Responsible party
Dennis T. Villareal (Professor, Baylor College of Medicine) — Principal investigator
First posted
Jan 29, 2018
Start date
Feb 1, 2018
Primary completion
Dec 31, 2019
Completion
May 31, 2022
Last update
Mar 23, 2023

Study contacts

Dennis T Villareal, MD
principal investigator · Baylor College of Medicine
Zheng Sun, PhD
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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