NCT02557165

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

4.4 years

First QC Date

September 2, 2015

Last Update Submit

September 21, 2015

Conditions

COPD

Keywords

Muscle regeneration

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

COPD patients

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

Procedure: Muscle biopsies

Patients with normal lung function

Patients with normal lung function having a scheduled lung surgery. Vastus lateralis and diaphragm muscle biopsies performed during surgery.

Procedure: Muscle biopsies

Interventions

Muscle biopsiesPROCEDURE

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.

COPD patientsPatients with normal lung function

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with a scheduled thoracic surgery

You may qualify if:

  • Patient with a scheduled thoracic surgery
  • ≥ 40 years
  • Smoking cessation ≥ 1 month
  • Smoking history ≥ 10 pack-year

You may not qualify if:

  • Subjects who received either chemiotherapy or radiotherapy
  • Hypoxemia
  • Body weight loss ≥ 10%
  • Use of systemic corticosteroid in the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 24666540BACKGROUND

  • 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.

    PMID: 22720047BACKGROUND

  • 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.

    PMID: 19359618BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Muscle biopsies from the quadriceps and diaphragm muscles

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Richard Debigare, PhD, PT

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2015

First Posted

September 23, 2015

Study Start

January 1, 2011

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09