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The Impact of Removal of Exercise on Glycemic Control and Vascular Health in Older Active Adults

Primary Purpose

Glucose Intolerance, Exercise, Vascular Function

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
removal of exercise
Sponsored by
Old Dominion University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Intolerance

Eligibility Criteria

undefined - undefined (Child, 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 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

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Metabolic

    Vascular

    Arm Description

    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

    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).

    Outcomes

    Primary Outcome Measures

    Continuous glucose monitoring
    Continuous glucose monitoring
    Continuous glucose monitoring
    Flow mediated dilation
    This measure assess blood vessel health non-invasively
    Flow mediated dilation (vascular health)
    This measure assess blood vessel health non-invasively
    Flow mediated dilation (vascular health)
    This measure assess blood vessel health non-invasively

    Secondary Outcome Measures

    Full Information

    First Posted
    May 9, 2022
    Last Updated
    July 19, 2022
    Sponsor
    Old Dominion University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05468255
    Brief Title
    The Impact of Removal of Exercise on Glycemic Control and Vascular Health in Older Active Adults
    Official Title
    The Impact of Removal of Exercise on Glycemic Control and Vascular Health in Older Active
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 25, 2022 (Anticipated)
    Primary Completion Date
    January 30, 2025 (Anticipated)
    Study Completion Date
    April 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Old Dominion University

    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.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glucose Intolerance, Exercise, Vascular Function

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Metabolic
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Vascular
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    removal of exercise
    Other Intervention Name(s)
    return to exercise
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Continuous glucose monitoring
    Time Frame
    3 days before removal of exercise
    Title
    Continuous glucose monitoring
    Time Frame
    After removal of exercise for 5 days
    Title
    Continuous glucose monitoring
    Time Frame
    After return to exercise for 3 days
    Title
    Flow mediated dilation
    Description
    This measure assess blood vessel health non-invasively
    Time Frame
    3 days before removal of exercise
    Title
    Flow mediated dilation (vascular health)
    Description
    This measure assess blood vessel health non-invasively
    Time Frame
    After removal of exercise for 5 days
    Title
    Flow mediated dilation (vascular health)
    Description
    This measure assess blood vessel health non-invasively
    Time Frame
    After return to exercise for 3 days

    10. Eligibility

    Sex
    All
    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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Leryn Reynolds
    Phone
    757-683-4974
    Email
    lreynold@odu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    The Impact of Removal of Exercise on Glycemic Control and Vascular Health in Older Active Adults

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