- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04812392
Physical Inactivity Impacts on Blood Vessel Health and Glucose Levels in an Aging Population
The Impact of 3 Days of Reduced Physical Activity on Endothelial Function and Glycemic Control in Active Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects will undergo testing in 2 study phases separated by at least 2 weeks: 1) active phase: subjects will have post meal glucose levels measured across 3 days of participating in their normal exercise routines. Blood vessel health will also be measured via flow mediated dilation at the end of the 3 day monitoring period. 2) physically inactive phase: subjects will stop participating in exercise for 3 days while post meal glucose levels are measured. Blood vessel health will also be assessed on days 1, 3 of removal of exercise. The subject will need to come into the lab on these days of inactivity to have blood vessel health measured.
The study procedures are described below.
Continuous Glucose Monitoring The investigators would like to gain more information about how blood sugar levels change over the course of a day in a free living setting. To do this the investigators will use a continuous glucose monitoring system (CGMS). This system is what individuals with diabetes frequently use to monitor their glucose levels over the course of the day. Subjects will be asked to wear the CGMS for 3 consecutive, full days on 2 different occasions. This includes 3 days during their normal regular physical activity, then for 3 days following during the no exercise protocol. The CGMS is worn on the stomach, and it is a tiny glucose sensor which is inserted just under the skin. This device measures and records blood glucose values throughout the day. In addition, subjects will be asked to make at least four finger stick blood glucose readings taken with a standard glucose meter at different times each day and record these numbers on a log sheet. During the continuous glucose monitoring, subjects will need to consume the same type and quantity of foods at the same time each day (i.e. whatever the subjects consumes on day 1 of baseline testing, they need to eat that exact same food, volume of food and at the same time on days 1-3 of the study). Meals and snacks consumed are also entered into a paper-based diary.
Blood Vessel Health Measurement (Flow Mediated Dilation: FMD) Subjects will be asked to perform their normal exercise routines 12-16 hours prior to blood vessel health being measured in the active phase as well as prior to the first blood vessel health measurement in the inactive phase to control for the acute effects of exercise on blood vessel health. Blood vessel health will be measured at the end of the active phase in both groups of subjects. Further blood vessel health will be measured following 1, 3 days of being inactive in both groups of subjects. Blood flow to the leg will be measured by applying blood pressure cuffs around the ankle. Pre flow mediated dilation diameter and velocity are recorded for 3 minutes prior to a blood pressure cuff being inflated for 5 minutes. Following cuff deflation, a 2-minute diameter and velocity recording is collected.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Norfolk, Virginia, United States, 23508
- Old Dominion University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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 metabolic disease, 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
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acute Physical Inactivity
Subjects will undergo 3 days of reduced physical activity.
|
Subjects will wear a continuous glucose monitoring system for 3 days during the 3 day reduced physical activity phase.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in glycemic control during a reduced physical activity state
Time Frame: The change of blood glucose values from pre-inactivity and following 3 days of inactivity
|
The change in blood glucose levels measured following consumption of a meal will be assessed before inactivity and following 3 days of inactivity.
|
The change of blood glucose values from pre-inactivity and following 3 days of inactivity
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leryn Reynolds, Ph.D., Old Dominion University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERP-2021-12576
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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