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Physical Inactivity Impacts on Blood Vessel Health and Glucose Levels in an Aging Population

Primary Purpose

Aging, Cardiovascular Diseases, Glucose Intolerance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitoring System
Sponsored by
Leryn Reynolds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Aging focused on measuring diabetes, physical inactivity, vascular function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 55 years and older, 18-40 years old
  2. Healthy, physically active, performing at least 90 min/week of physical activity
  3. Free of physical limitations that may interfere with alterations in daily physical activity levels

Exclusion Criteria:

  1. Physician diagnosed metabolic disease, HIV, hepatitis, or tuberculosis.
  2. Body weight change of greater than 5% within the previous 2 months
  3. Smoking within the previous 2 months.
  4. Taking medications that alter blood glucose levels

Sites / Locations

  • Old Dominion University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute Physical Inactivity

Arm Description

Subjects will undergo 3 days of reduced physical activity.

Outcomes

Primary Outcome Measures

Change in glycemic control during a reduced physical activity state
The change in blood glucose levels measured following consumption of a meal will be assessed before inactivity and following 3 days of inactivity.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2021
Last Updated
August 2, 2022
Sponsor
Leryn Reynolds
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1. Study Identification

Unique Protocol Identification Number
NCT04812392
Brief Title
Physical Inactivity Impacts on Blood Vessel Health and Glucose Levels in an Aging Population
Official Title
The Impact of 3 Days of Reduced Physical Activity on Endothelial Function and Glycemic Control in Active Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leryn Reynolds

4. Oversight

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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Physical inactivity is known to increase post meal blood sugar levels in young, active populations. However, how quickly this may occur in active, older adults is not clear. Further, the relationship between blood vessel health and blood sugar disturbances which occur to acute physical inactivity is not clear. It is unknown if impairments in blood vessel function precede increases in blood sugar levels that occurs with inactivity in an aging population. This study aims to determine if short term reductions in physical activity impair blood vessel health and blood glucose control to a greater extent in an aging population compared to a young population. The investigators hypothesize that 3 days of reduced physical activity will result in impaired blood vessel function and glycemic control in an aged population.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Cardiovascular Diseases, Glucose Intolerance
Keywords
diabetes, physical inactivity, vascular function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute Physical Inactivity
Arm Type
Experimental
Arm Description
Subjects will undergo 3 days of reduced physical activity.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring System
Intervention Description
Subjects will wear a continuous glucose monitoring system for 3 days during the 3 day reduced physical activity phase.
Primary Outcome Measure Information:
Title
Change in glycemic control during a reduced physical activity state
Description
The change in blood glucose levels measured following consumption of a meal will be assessed before inactivity and following 3 days of inactivity.
Time Frame
The change of blood glucose values from pre-inactivity and following 3 days of inactivity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leryn Reynolds, Ph.D.
Organizational Affiliation
Old Dominion University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Old Dominion University
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23508
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Physical Inactivity Impacts on Blood Vessel Health and Glucose Levels in an Aging Population

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