- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02557165
Impact of COPD on Muscle Regeneration
September 21, 2015 updated by: Laval University
Impact of Chronic Obstructive Pulmonary Disease on Peripheral and Respiratory Muscle Regeneration
Muscle weakness and atrophy are important consequences of chronic obstructive pulmonary disease (COPD) and can affect both respiratory and peripheral muscles.
Impaired muscle regeneration is thought to be implicated in the process of muscle atrophy.
In this study the investigators will evaluate muscle regenerative potential of the Vastus Lateralis (VL) and diaphragm of patients with COPD, compared to patients with normal lung function.
Study Overview
Detailed Description
Preliminary results suggest that the activation and differentiation processes of satellite cells isolated from the VL of patients with COPD could be altered.
The investigators propose to compare the regenerative potential of the VL and the diaphragm in 15 patients with COPD and 15 individuals with normal lung function undergoing a thoracic surgery.
From muscle biopsies, satellite cells will be isolated and cultured to assess their proliferation and differentiation rates, and the expression level of myogenic effectors (MyoD, Myf5, myogenin, and MRF4).
Alterations in these measurements will confirm the hypotheses that the regenerative potential is lower in both muscle groups in patients with COPD compared to controls and that in COPD, the regenerative potential is lower in VL compared to the diaphragm.
Study Type
Observational
Enrollment (Actual)
27
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
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient with a scheduled thoracic surgery
Description
Inclusion Criteria:
- Patient with a scheduled thoracic surgery
- ≥ 40 years
- Smoking cessation ≥ 1 month
- Smoking history ≥ 10 pack-year
Exclusion Criteria:
- Subjects who received either chemiotherapy or radiotherapy
- Hypoxemia
- Body weight loss ≥ 10%
- Use of systemic corticosteroid in the last month
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
Patients with mild to moderate COPD having a scheduled lung surgery.
Vastus lateralis and diaphragm muscle biopsies performed during surgery
|
Muscle biopsies will allow acces to samples for observational studies.
Vastus latetalis: needle biopsy (Bergstrom technique).
Diaphragm: open biopsy performed by thoracic surgeon during lung surgery.
|
|
Patients with normal lung function
Patients with normal lung function having a scheduled lung surgery.
Vastus lateralis and diaphragm muscle biopsies performed during surgery.
|
Muscle biopsies will allow acces to samples for observational studies.
Vastus latetalis: needle biopsy (Bergstrom technique).
Diaphragm: open biopsy performed by thoracic surgeon during lung surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle satellite cell proliferation index
Time Frame: Sequential analyses performed over a period of 2 weeks after tissue collection.
|
Isolation from muscle biopsies of satellite cell to evaluate their regeneration capacity by evaluating the proliferation capacity
|
Sequential analyses performed over a period of 2 weeks after tissue collection.
|
|
Muscle satellite cell differentiation index
Time Frame: Sequential analyses performed over a period of 2 months after tissue collection.
|
Isolation from muscle biopsies of satellite cell to evaluate their regeneration capacity by evaluating the differentiation capacity
|
Sequential analyses performed over a period of 2 months after tissue collection.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Debigare, PhD, PT, Laval University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Theriault ME, Pare ME, Lemire BB, Maltais F, Debigare R. Regenerative defect in vastus lateralis muscle of patients with chronic obstructive pulmonary disease. Respir Res. 2014 Mar 25;15(1):35. doi: 10.1186/1465-9921-15-35.
- Theriault ME, Pare ME, Maltais F, Debigare R. Satellite cells senescence in limb muscle of severe patients with COPD. PLoS One. 2012;7(6):e39124. doi: 10.1371/journal.pone.0039124. Epub 2012 Jun 13.
- Caron MA, Debigare R, Dekhuijzen PN, Maltais F. Comparative assessment of the quadriceps and the diaphragm in patients with COPD. J Appl Physiol (1985). 2009 Sep;107(3):952-61. doi: 10.1152/japplphysiol.00194.2009. Epub 2009 Apr 9.
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
January 1, 2011
Primary Completion (Actual)
June 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
September 2, 2015
First Submitted That Met QC Criteria
September 21, 2015
First Posted (Estimate)
September 23, 2015
Study Record Updates
Last Update Posted (Estimate)
September 23, 2015
Last Update Submitted That Met QC Criteria
September 21, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CRT114804
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.