Bed-rest, Muscle Mass and Insulin Sensitivity
Primary Purpose
Disuse Atrophy
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Bed rest
Sponsored by
About this trial
This is an interventional basic science trial for Disuse Atrophy
Eligibility Criteria
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
Sites / Locations
- Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bed rest
Arm Description
One week of bed rest.
Outcomes
Primary Outcome Measures
Change in quadriceps muscle cross-sectional area
Secondary Outcome Measures
Change in lower back cross-sectional area
Change in leg and whole body lean tissue mass
Change in muscle fiber size
Change in muscle strength
Measured by 1-Repetition Maximum testing
Change in insulin sensitivity
Measured by hyperinsulinemic-euglycemic clamp
Full Information
NCT ID
NCT02109380
First Posted
April 1, 2014
Last Updated
April 27, 2015
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02109380
Brief Title
Bed-rest, Muscle Mass and Insulin Sensitivity
Official Title
The Impact of Short-term Bed-rest on Skeletal Muscle Mass and Insulin Sensitivity in Healthy, Young Men
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the present study, the effects of 7 days of bed rest on muscle mass, muscle fiber characteristics and insulin sensitivity will be determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disuse Atrophy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bed rest
Arm Type
Experimental
Arm Description
One week of bed rest.
Intervention Type
Behavioral
Intervention Name(s)
Bed rest
Primary Outcome Measure Information:
Title
Change in quadriceps muscle cross-sectional area
Time Frame
One day before and directly after cessation of bed rest.
Secondary Outcome Measure Information:
Title
Change in lower back cross-sectional area
Time Frame
One day before and directly after cessation of bed rest.
Title
Change in leg and whole body lean tissue mass
Time Frame
One day before and directly after cessation of bed rest.
Title
Change in muscle fiber size
Time Frame
One day before and directly after cessation of bed rest.
Title
Change in muscle strength
Description
Measured by 1-Repetition Maximum testing
Time Frame
One day before and directly after cessation of bed rest.
Title
Change in insulin sensitivity
Description
Measured by hyperinsulinemic-euglycemic clamp
Time Frame
One day before and directly after cessation of bed rest.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc JC van Loon, PhD
Organizational Affiliation
Maastricht UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
27358494
Citation
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.
Results Reference
derived
PubMed Identifier
27124248
Citation
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.
Results Reference
derived
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Bed-rest, Muscle Mass and Insulin Sensitivity
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