- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02109380
Bed-rest, Muscle Mass and Insulin Sensitivity
April 27, 2015 updated by: Lex Verdijk, Maastricht University Medical Center
The Impact of Short-term Bed-rest on Skeletal Muscle Mass and Insulin Sensitivity in Healthy, Young Men
In the present study, the effects of 7 days of bed rest on muscle mass, muscle fiber characteristics and insulin sensitivity will be determined.
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maastricht, Netherlands
- Maastricht University Medical Centre
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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 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- Aged from 18-35 years
- 18.5 < BMI < 30 kg/m2
Exclusion Criteria:
- Smoking
- Performing regular resistance training (3+ times per week, carrying out progressive training) in the previous 6 months
- Hypertension (according to WHO criteria) and/or cardiovascular disease
- Any back/leg/knee/neck/postural complaints
- Use of any prescribed medication
- Type 2 diabetes mellitus
- Any family history of thrombosis
- All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
- Myocardial infarction within the last 3 years
- Use of anti-coagulants
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Bed rest
One week of bed rest.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in quadriceps muscle cross-sectional area
Time Frame: One day before and directly after cessation of bed rest.
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One day before and directly after cessation of bed rest.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in lower back cross-sectional area
Time Frame: One day before and directly after cessation of bed rest.
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One day before and directly after cessation of bed rest.
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Change in leg and whole body lean tissue mass
Time Frame: One day before and directly after cessation of bed rest.
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One day before and directly after cessation of bed rest.
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Change in muscle fiber size
Time Frame: One day before and directly after cessation of bed rest.
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One day before and directly after cessation of bed rest.
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Change in muscle strength
Time Frame: One day before and directly after cessation of bed rest.
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Measured by 1-Repetition Maximum testing
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One day before and directly after cessation of bed rest.
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Change in insulin sensitivity
Time Frame: One day before and directly after cessation of bed rest.
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Measured by hyperinsulinemic-euglycemic clamp
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One day before and directly after cessation of bed rest.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dirks ML, Wall BT, van de Valk B, Holloway TM, Holloway GP, Chabowski A, Goossens GH, van Loon LJ. One Week of Bed Rest Leads to Substantial Muscle Atrophy and Induces Whole-Body Insulin Resistance in the Absence of Skeletal Muscle Lipid Accumulation. Diabetes. 2016 Oct;65(10):2862-75. doi: 10.2337/db15-1661. Epub 2016 Jun 29.
- Dirks ML, Backx EM, Wall BT, Verdijk LB, van Loon LJ. May bed rest cause greater muscle loss than limb immobilization? Acta Physiol (Oxf). 2016 Sep;218(1):10-2. doi: 10.1111/apha.12699. Epub 2016 May 20. No abstract available.
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
June 1, 2014
Primary Completion (ACTUAL)
April 1, 2015
Study Registration Dates
First Submitted
April 1, 2014
First Submitted That Met QC Criteria
April 4, 2014
First Posted (ESTIMATE)
April 9, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
April 28, 2015
Last Update Submitted That Met QC Criteria
April 27, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC 14-3-013
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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