NCT03414385

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

January 17, 2018

Last Update Submit

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

EXPERIMENTAL

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

Acute bout of aerobic exercise at moderate intensity for 2 hours

Exercise group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dennis T Villareal, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR
  • Zheng Sun, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

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

Locations