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Two-day Bed Rest, Insulin Sensitivity and Muscle Protein Synthesis (2d-BR)

Primary Purpose

Healthy

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Habitual activity
Bed rest
Sponsored by
University of Exeter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Male
  • Aged 18-40

Exclusion Criteria:

  • Smoker
  • Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
  • Any diagnosed cardiovascular disease (e.g. deep vein thrombosis or hypertension)
  • Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism).
  • A personal or family history of thrombosis, epilepsy, seizures or schizophrenia.
  • Any known disorders in muscle metabolism
  • Regular use of nutritional supplements (i.e. ingestion more than twice per week during the last month)
  • Metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws).
  • Allergy to lidocaine
  • Recent (within the last 6 months) or current musculoskeletal injury (e.g. leg fracture)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Habitual activity and 2 days bed rest

    Arm Description

    Participants will undergo 2 days of habitual activity and 2 days bed rest

    Outcomes

    Primary Outcome Measures

    Change in whole-body insulin sensitivity
    Change in whole-body insulin sensitivity via meal tolerance test

    Secondary Outcome Measures

    Change in cumulative muscle protein synthesis
    Cumulative muscle protein synthesis via deuterium oxide ingestion. The incorporation of deuterated alanine in muscle is expressed relative to body water enrichments, to obtain muscle protein synthesis in %/day
    Change in continuous glucose
    Change in continuous glucose via continuous glucose monitoring.
    Change in muscle volume
    Change in muscle volume via MRI

    Full Information

    First Posted
    February 28, 2019
    Last Updated
    November 9, 2021
    Sponsor
    University of Exeter
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03877822
    Brief Title
    Two-day Bed Rest, Insulin Sensitivity and Muscle Protein Synthesis
    Acronym
    2d-BR
    Official Title
    The Impact of Two Days of Bed Rest Versus Two Days of Habitual Activity on Insulin Sensitivity and Cumulative Muscle Protein Synthesis in Healthy Young Males
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study protocol no longer relevant after progression of the scientific field
    Study Start Date
    September 1, 2021 (Actual)
    Primary Completion Date
    September 1, 2021 (Actual)
    Study Completion Date
    September 1, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Exeter

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The impact of two days bed rest versus two days of habitual activity on insulin sensitivity and cumulative muscle protein synthesis will be investigated in healthy young males
    Detailed Description
    To study the mechanisms underlying inactivity-induced muscle atrophy, the impact of two days bed rest versus two days of habitual activity on insulin sensitivity and cumulative muscle protein synthesis will be investigated in healthy young males

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Participants will firstly undergo 2 days of habitual physical activity, followed by 2 days of bed rest
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Habitual activity and 2 days bed rest
    Arm Type
    Experimental
    Arm Description
    Participants will undergo 2 days of habitual activity and 2 days bed rest
    Intervention Type
    Behavioral
    Intervention Name(s)
    Habitual activity
    Intervention Description
    Two days of habitual physical activity, under normal free-living conditions
    Intervention Type
    Behavioral
    Intervention Name(s)
    Bed rest
    Intervention Description
    Two days of bed rest, to induce whole-body physical inactivity
    Primary Outcome Measure Information:
    Title
    Change in whole-body insulin sensitivity
    Description
    Change in whole-body insulin sensitivity via meal tolerance test
    Time Frame
    During 2 days of habitual physical activity and 2 days of bed rest. Blood glucose and insulin are monitored for 2 hours following ingestion of a standardized meal
    Secondary Outcome Measure Information:
    Title
    Change in cumulative muscle protein synthesis
    Description
    Cumulative muscle protein synthesis via deuterium oxide ingestion. The incorporation of deuterated alanine in muscle is expressed relative to body water enrichments, to obtain muscle protein synthesis in %/day
    Time Frame
    During 2 days of habitual physical activity and 2 days of bed rest
    Title
    Change in continuous glucose
    Description
    Change in continuous glucose via continuous glucose monitoring.
    Time Frame
    Continuous glucose, during the 2 days of habitual activity and 2 days of bed rest
    Title
    Change in muscle volume
    Description
    Change in muscle volume via MRI
    Time Frame
    Immediately before and immediately after the 2-day bed rest period

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male Aged 18-40 Exclusion Criteria: Smoker Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes) Any diagnosed cardiovascular disease (e.g. deep vein thrombosis or hypertension) Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism). A personal or family history of thrombosis, epilepsy, seizures or schizophrenia. Any known disorders in muscle metabolism Regular use of nutritional supplements (i.e. ingestion more than twice per week during the last month) Metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws). Allergy to lidocaine Recent (within the last 6 months) or current musculoskeletal injury (e.g. leg fracture)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marlou L Dirks, PhD
    Organizational Affiliation
    University of Exeter
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Two-day Bed Rest, Insulin Sensitivity and Muscle Protein Synthesis

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