- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03877822
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Withdrawn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
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
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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