- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05468255
The Impact of Removal of Exercise on Glycemic Control and Vascular Health in Older Active Adults
April 9, 2024 updated by: Leryn Reynolds, Old Dominion University
The Impact of Removal of Exercise on Glycemic Control and Vascular Health in Older Active
The purpose of this study is to determine if an acute bout of removal of exercise reduces enothelial function and glycemic control in an active, older adult population; and whether a 3 day return to exercise restores this response.
Glycemic control is the blood glucose response following the consumption of a meal.
It is an indicator of insulin resistance (or type 2 diabetes) and impaired glycemic control has been suggested to lead to cardiovascular disease.
Endothelial function has been shown to be improved by chronic or acute increases in physical activity.
Both of these have been shown to be impaired to acute bouts of inactivity in young populations; however the impact of acute inactivity in older adults is less understood.
In this proposal the investigators will examine 1)how quickly impairments in glycemic control occur to acute physical inactivity in older adults who exercise, 2) how quickly impairments in endothelial function occur to acute inactivity in older adults who exercise, and 3) whether 3 days of a return to exercise restores these responses.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Leryn Reynolds
- Phone Number: 757-683-4974
- Email: lreynold@odu.edu
Study Locations
-
-
Virginia
-
Norfolk, Virginia, United States, 23529
- Recruiting
- Old Dominion University
-
Contact:
- Leryn J Reynolds
- Phone Number: 757-683-4974
- Email: lreynold@odu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 55 years and older, 18-40 years old
- Healthy, physically active, performing at least 90 min/week of physical activity
- Free of physical limitations that may interfere with alterations in daily physical activity levels
Exclusion Criteria:
- Physician diagnosed HIV, hepatitis, or tuberculosis.
- Body weight change of greater than 5% within the previous 2 months
- Smoking within the previous 2 months.
- Taking medications that alter blood glucose levels
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Metabolic
Metabolic: Participants will have their blood glucose levels measured via continuous glucose monitoring for 3 days while participating in their normal exercise routines (EX).
Participants will also have their blood glucose levels measured for 3 days while not exercising (NOEX), following immediately by 3 days of a return to normal activity(REX).
Participants will be randomized to participate in the EX or NOEX/REX phases first.
The EX and NOEX/REX phases will be separated by at least 1 week
|
Subjects will stop doing their normal exercise routines for 3 or 5 days and then subjects will resume doing their normal exercise routines for 3 days.
Other Names:
|
|
Experimental: Vascular
Vascular: Participants will have their blood vessel health measured while performing their normal exercise routines (EX) and while undergoing 1, 3, 5 days of no exercise (NOEX) followed immediately by 1 and 3 days of return to exercise (REX).
|
Subjects will stop doing their normal exercise routines for 3 or 5 days and then subjects will resume doing their normal exercise routines for 3 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Continuous glucose monitoring
Time Frame: 3 days before removal of exercise
|
3 days before removal of exercise
|
|
|
Continuous glucose monitoring
Time Frame: After removal of exercise for 5 days
|
After removal of exercise for 5 days
|
|
|
Continuous glucose monitoring
Time Frame: After return to exercise for 3 days
|
After return to exercise for 3 days
|
|
|
Flow mediated dilation
Time Frame: 3 days before removal of exercise
|
This measure assess blood vessel health non-invasively
|
3 days before removal of exercise
|
|
Flow mediated dilation (vascular health)
Time Frame: After removal of exercise for 5 days
|
This measure assess blood vessel health non-invasively
|
After removal of exercise for 5 days
|
|
Flow mediated dilation (vascular health)
Time Frame: After return to exercise for 3 days
|
This measure assess blood vessel health non-invasively
|
After return to exercise for 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2022
Primary Completion (Estimated)
January 30, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
May 9, 2022
First Submitted That Met QC Criteria
July 19, 2022
First Posted (Actual)
July 21, 2022
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGEGLYFMD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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