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

November 9, 2021 updated by: University of Exeter

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

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 Overview

Status

Withdrawn

Conditions

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Habitual activity and 2 days bed rest
Participants will undergo 2 days of habitual activity and 2 days bed rest
Two days of habitual physical activity, under normal free-living conditions
Two days of bed rest, to induce whole-body physical inactivity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Measures

Outcome Measure
Measure Description
Time Frame
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
During 2 days of habitual physical activity and 2 days of bed rest
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.
Continuous glucose, during the 2 days of habitual activity and 2 days of bed rest
Change in muscle volume
Time Frame: Immediately before and immediately after the 2-day bed rest period
Change in muscle volume via MRI
Immediately before and immediately after the 2-day bed rest period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marlou L Dirks, PhD, University of Exeter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

February 28, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 190206/B/05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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