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

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ClinicalTrials.gov Identifier: NCT03877822
Recruitment Status : Withdrawn (Study protocol no longer relevant after progression of the scientific field)
First Posted : March 18, 2019
Last Update Posted : November 17, 2021
Sponsor:
Information provided by (Responsible Party):
University of Exeter

Study Description
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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

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Habitual activity Behavioral: Bed rest Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will firstly undergo 2 days of habitual physical activity, followed by 2 days of bed rest
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : September 1, 2021
Actual Primary Completion Date : September 1, 2021
Actual Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Habitual activity and 2 days bed rest
Participants will undergo 2 days of habitual activity and 2 days bed rest
 Behavioral: Habitual activity
Two days of habitual physical activity, under normal free-living conditions

Behavioral: Bed rest
Two days of bed rest, to induce whole-body physical inactivity


Outcome Measures
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Primary Outcome Measures :
  1. Change in whole-body insulin sensitivity [ 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 ]
    Change in whole-body insulin sensitivity via meal tolerance test


Secondary Outcome Measures :
  1. Change in cumulative muscle protein synthesis [ Time Frame: During 2 days of habitual physical activity and 2 days of bed rest ]
    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

  2. Change in continuous glucose [ Time Frame: Continuous glucose, during the 2 days of habitual activity and 2 days of bed rest ]
    Change in continuous glucose via continuous glucose monitoring.

  3. Change in muscle volume [ Time Frame: Immediately before and immediately after the 2-day bed rest period ]
    Change in muscle volume via MRI


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877822


Sponsors and Collaborators
University of Exeter
Investigators
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Principal Investigator: Marlou L Dirks, PhD University of Exeter
More Information
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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT03877822    
Other Study ID Numbers: 190206/B/05
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases