Bed-rest, Muscle Mass and Insulin Sensitivity

Disuse Atrophy Clinical Trial

Official title:

The Impact of Short-term Bed-rest on Skeletal Muscle Mass and Insulin Sensitivity in Healthy, Young Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109380
• Other study ID #: METC 14-3-013
• Status: Completed
• Phase: N/A
• First received: April 1, 2014
• Last updated: April 27, 2015
• Start date: June 2014

Study information

• Verified date: April 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Disuse Atrophy

Intervention

Behavioral:
• Bed rest

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quadriceps muscle cross-sectional area		One day before and directly after cessation of bed rest.	No
Secondary	Change in lower back cross-sectional area		One day before and directly after cessation of bed rest.	No
Secondary	Change in leg and whole body lean tissue mass		One day before and directly after cessation of bed rest.	No
Secondary	Change in muscle fiber size		One day before and directly after cessation of bed rest.	No
Secondary	Change in muscle strength	Measured by 1-Repetition Maximum testing	One day before and directly after cessation of bed rest.	No
Secondary	Change in insulin sensitivity	Measured by hyperinsulinemic-euglycemic clamp	One day before and directly after cessation of bed rest.	No