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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02557165
Other study ID # CRT114804
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 2, 2015
Last updated September 21, 2015
Start date January 2011
Est. completion date December 2015

Study information

Verified date September 2015
Source Laval University
Contact n/a
Is FDA regulated No
Health authority Canada: Ministère santé et services sociaux du Québec
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 27
Est. completion date December 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility 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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Muscle biopsies
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Laval University GlaxoSmithKline

References & Publications (3)

Caron MA, Debigaré 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. Review. — View Citation

Thériault ME, Paré MÈ, Lemire BB, Maltais F, Debigaré R. Regenerative defect in vastus lateralis muscle of patients with chronic obstructive pulmonary disease. Respir Res. 2014 Mar 25;15:35. doi: 10.1186/1465-9921-15-35. — View Citation

Thériault ME, Paré MÈ, Maltais F, Debigaré 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle satellite cell proliferation index 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. No
Primary Muscle satellite cell differentiation index 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. No
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