Muscle Atrophy In Patients With Chronic Obstructive Pulmonary Disease

September 7, 2016 updated by: Annie Dubé, Laval University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with COPD

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease of protein degradation in muscles of wasted COPD patients
Time Frame: At baseline (COPD in a stable state of the disease)
At baseline (COPD in a stable state of the disease)

Secondary Outcome Measures

Outcome Measure
Time Frame
Increase of protein synthesis in muscles of wasted COPD patients
Time Frame: At baseline (COPD in a stable state of the disease)
At baseline (COPD in a stable state of the disease)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: François Maltais, MD, PhD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Estimate)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COPD-20739

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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