Impact of COPD on Muscle Regeneration

NCT ID: NCT02557165

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COPD patients

Patients with mild to moderate COPD having a scheduled lung surgery. Vastus lateralis and diaphragm muscle biopsies performed during surgery

Muscle biopsies

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard Debigare, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Laval University

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24666540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22720047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19359618 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRT114804

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.