Glucose IntoleranceNCT05468255
The Impact of Removal of Exercise on Glycemic Control and Vascular Health in Older Active Adults
A study testing removal of exercise in people with Glucose Intolerance and Exercise, run by Old Dominion University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance, Exercise, Vascular Function
- What is being tested?
- removal of exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2022to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Old Dominion University
Norfolk, Virginia, 23529
Leryn J Reynolds, 757-683-4974, lreynold@odu.edu
About this study
Official title: 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.
- Conditions
- Glucose Intolerance, Exercise, Vascular Function
- Being tested
- removal of exercise
- Medical subject headings
- Glucose Intolerance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
removal of exerciseOther
Also called return to exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| Metabolic | Experimental | 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 Receives: Other: removal of exercise |
| Vascular | Experimental | 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). Receives: Other: removal of exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous glucose monitoring
Measured: 3 days before removal of exercise
Continuous glucose monitoring
Measured: After removal of exercise for 5 days
Continuous glucose monitoring
Measured: After return to exercise for 3 days
Flow mediated dilation
This measure assess blood vessel health non-invasively
Measured: 3 days before removal of exercise
Flow mediated dilation (vascular health)
This measure assess blood vessel health non-invasively
Measured: After removal of exercise for 5 days
Flow mediated dilation (vascular health)
This measure assess blood vessel health non-invasively
Measured: After return to exercise for 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start25 Jul 2022
- Primary completion30 Jan 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Old Dominion University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leryn Reynolds, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468255
- Sponsor's protocol ID
- AGEGLYFMD
- Status last verified
- Apr 2024
- First submitted
- 9 May 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Removal of Exercise on Glycemic Control and Vascular Health in Older Active
- ClinicalTrials.gov ID
- NCT05468255
- Acronym / sponsor ID
- AGEGLYFMD
- Conditions
- Glucose Intolerance, Exercise, Vascular Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metabolic | Experimental | Other: removal of exerciseMetabolic: 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 |
| Vascular | Experimental | Other: removal of exerciseVascular: 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| removal of exerciseAlso: return to exerciseSubjects 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 | Metabolic, Vascular |
Primary outcome
Continuous glucose monitoring
Time frame: 3 days before removal of exercise
Continuous glucose monitoring
Time frame: After removal of exercise for 5 days
Continuous glucose monitoring
Time frame: 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
Flow mediated dilation (vascular health)
Time frame: After removal of exercise for 5 days
This measure assess blood vessel health non-invasively
Flow mediated dilation (vascular health)
Time frame: After return to exercise for 3 days
This measure assess blood vessel health non-invasively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing removal of exercise in people with Glucose Intolerance and Exercise, run by Old Dominion University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leryn Reynolds (757-683-4974, lreynold@odu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous glucose monitoring (time frame: 3 days before removal of exercise). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.