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Muscle Atrophy In Patients With Chronic Obstructive Pulmonary Disease

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284932
First Posted: November 6, 2014
Last Update Posted: September 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Annie Dubé, Laval University
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease Other: No specific intervention for this study

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Weeks
Official Title: Muscle Atrophy In Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Annie Dubé, Laval University:

Primary Outcome Measures:
  • Decrease of protein degradation in muscles of wasted COPD patients [ Time Frame: At baseline (COPD in a stable state of the disease) ]

Secondary Outcome Measures:
  • Increase of protein synthesis in muscles of wasted COPD patients [ Time Frame: At baseline (COPD in a stable state of the disease) ]

Biospecimen Retention:   Samples With DNA
Blood sample and muscle biopsy of vastus lateralis (quadriceps)

Estimated Enrollment: 36
Study Start Date: September 2011
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
COPD patients
Group : COPD patients No specific intervention for this study
Other: No specific intervention for this study
No specific intervention for this study
Healthy controls
Group : healthy volunteers No specific intervention for this study
Other: No specific intervention for this study
No specific intervention for this study

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with COPD
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284932


Locations
Canada
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: François Maltais, MD, PhD Institut universitaire de cardiologie et de pneumologie de Québec
  More Information

Responsible Party: Annie Dubé, Professionelle de recherche, Laval University
ClinicalTrials.gov Identifier: NCT02284932     History of Changes
Other Study ID Numbers: COPD-20739
First Submitted: October 8, 2014
First Posted: November 6, 2014
Last Update Posted: September 8, 2016
Last Verified: September 2016

Keywords provided by Annie Dubé, Laval University:
COPD
atrophy
muscle

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Atrophy
Muscular Atrophy
Respiratory Tract Diseases
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms