Disuse AtrophyNCT02109380
Bed-rest, Muscle Mass and Insulin Sensitivity
A study testing Bed rest in people with Disuse Atrophy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Disuse Atrophy
- What is being tested?
- Bed rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged from 18-35 years
- 18.5 < BMI < 30 kg/m2
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Disuse Atrophy
- Being tested
- Bed rest
- Medical subject headings
- Muscular Disorders, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed restBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Bed rest | Experimental | One week of bed rest. Receives: Behavioral: Bed rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quadriceps muscle cross-sectional area
Measured: One day before and directly after cessation of bed rest.
Secondary outcomes (5)
Change in lower back cross-sectional area
Measured: One day before and directly after cessation of bed rest.
Change in leg and whole body lean tissue mass
Measured: One day before and directly after cessation of bed rest.
Change in muscle fiber size
Measured: One day before and directly after cessation of bed rest.
Change in muscle strength
Measured by 1-Repetition Maximum testing
Measured: One day before and directly after cessation of bed rest.
Change in insulin sensitivity
Measured by hyperinsulinemic-euglycemic clamp
Measured: One day before and directly after cessation of bed rest.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disuse AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lex Verdijk, Maastricht University Medical Center
- Investigators
- Luc JC van Loon, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109380
- Sponsor's protocol ID
- METC 14-3-013
- Status last verified
- Apr 2015
- First submitted
- 1 Apr 2014
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27358494Dirks 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.
PubMed 27124248
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Short-term Bed-rest on Skeletal Muscle Mass and Insulin Sensitivity in Healthy, Young Men
- ClinicalTrials.gov ID
- NCT02109380
- Acronym / sponsor ID
- METC 14-3-013
- Conditions
- Disuse Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bed rest | Experimental | Behavioral: Bed restOne week of bed rest. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- Aged from 18-35 years
- 18.5 < BMI < 30 kg/m2
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bed rest | Behavioural | Bed rest |
Primary outcome
Change in quadriceps muscle cross-sectional area
Time frame: One day before and directly after cessation of bed rest.
5 secondary outcomes
Change in lower back cross-sectional area
Time frame: One day before and directly after cessation of bed rest.
Change in leg and whole body lean tissue mass
Time frame: One day before and directly after cessation of bed rest.
Change in muscle fiber size
Time frame: One day before and directly after cessation of bed rest.
Change in muscle strength
Time frame: One day before and directly after cessation of bed rest.
Change in insulin sensitivity
Time frame: One day before and directly after cessation of bed rest.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Derived from this study: PubMed 27358494Dirks 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.
- Derived from this study: PubMed 27124248Dirks 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.
Related trials for Disuse Atrophy
Recruiting
Heat Therapy During Reduced Physical Activity
Physical Inactivity, Vascular Dysfunction
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Effect of Knee Position on Muscle Loss During Leg Immobilization
Muscle Atrophy, Disuse Atrophy
Active, not recruiting
Sex-specific Determinants of Early-phase Recovery From Skeletal Muscle Disuse
Atrophy of Muscle Due to Disuse, Rehabilitation
Not yet recruiting
Cross-education of Skill and Strength in Healthy People Subjected to an Upper-limb Disuse Model
Disuse Atrophy, Immobilization
Recruiting
Exercise and Monitoring With Post-Hospitalization Muscle Atrophy to Sustain Intrinsic Capacity and Strength
Chronic Kidney Disease (CKD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc JC van Loon, PhD principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bed rest in people with Disuse Atrophy, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quadriceps muscle cross-sectional area (time frame: One day before and directly after cessation of bed rest.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02109380, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.