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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02284932
Other study ID # COPD-20739
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 8, 2014
Last updated September 7, 2016
Start date September 2011
Est. completion date September 2018

Study information

Verified date September 2016
Source Laval University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational [Patient Registry]

Clinical Trial Summary

Limb muscle dysfunction, characterized by atrophy and weakness, is amongst the most troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to poor functional status and premature mortality.

One prevailing hypothesis stipulates that the deterioration in muscle structure and function during COPD results from a spillover of inflammatory mediators from the lungs to the systemic circulation and then to the muscles.


Description:

The investigators objective is to investigate the impact of COPD on key signaling pathways involved in the muscle atrophy. Moderate to severe COPD patients (FEV1 under 60% of predicted) and healthy controls will be recruited. All of the investigators patients will undergo a thorough baseline assessment in pulmonary capacity, muscle force and body composition. Blood sampling and biopsy of the quadriceps will be done. Key proteins of signaling intramuscular pathways involved in protein synthesis and degradation will be measured in the quadriceps.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 36
Est. completion date September 2018
Est. primary completion date September 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 55 Years to 75 Years
Eligibility Inclusion Criteria:

- male

- COPD with an FEV1 of under 60% of predicted

- non-smoker

- between 55 and 75 years old

Exclusion Criteria:

- all inflammatory disease (HIV, cancer, renal and cardiac deficiency)

- hormonal dysregulation

- inferior limb pathology

- neuromuscular pathology

- history of tobacco or alcool abuse

- oxygen dependent

- recent exacerbation (2 months) of the symptoms of COPD

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
No specific intervention for this study
No specific intervention for this study

Locations

Country Name City State
Canada Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec Quebec

Sponsors (2)

Lead Sponsor Collaborator
Laval University Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decrease of protein degradation in muscles of wasted COPD patients At baseline (COPD in a stable state of the disease) No
Secondary Increase of protein synthesis in muscles of wasted COPD patients At baseline (COPD in a stable state of the disease) No
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