COPDNCT02557165
Impact of COPD on Muscle Regeneration
An observational study of COPD, run by Laval University.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Muscle biopsies
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with a scheduled thoracic surgery
Who may be able to join
- Patient with a scheduled thoracic surgery
- ≥ 40 years
- Smoking cessation ≥ 1 month
- Smoking history ≥ 10 pack-year
Who cannot join
- Subjects who received either chemiotherapy or radiotherapy
- Hypoxemia
- Body weight loss ≥ 10%
- Use of systemic corticosteroid in the last month
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD
- Being tested
- Muscle biopsies
- Keywords
- Muscle regeneration
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle biopsiesProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Patients with mild to moderate COPD having a scheduled lung surgery. Vastus lateralis and diaphragm muscle biopsies performed during surgery Receives: 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. Receives: Procedure: Muscle biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle satellite cell proliferation index
Isolation from muscle biopsies of satellite cell to evaluate their regeneration capacity by evaluating the proliferation capacity
Measured: 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
Measured: Sequential analyses performed over a period of 2 months after tissue collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startJan 2011
- Primary completionJun 2015
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Richard Debigare, PhD, PT, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557165
- Sponsor's protocol ID
- CRT114804
- Status last verified
- Sep 2015
- First submitted
- 2 Sep 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24666540Theriault 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.
PubMed 22720047Caron 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.
PubMed 19359618
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Obstructive Pulmonary Disease on Peripheral and Respiratory Muscle Regeneration
- ClinicalTrials.gov ID
- NCT02557165
- Acronym / sponsor ID
- CRT114804
- Conditions
- COPD
- Keywords
- Muscle regeneration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Procedure: Muscle biopsiesPatients with mild to moderate COPD having a scheduled lung surgery. Vastus lateralis and diaphragm muscle biopsies performed during surgery |
| Patients with normal lung function | – | Procedure: Muscle biopsiesPatients with normal lung function having a scheduled lung surgery. Vastus lateralis and diaphragm muscle biopsies performed during surgery. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a scheduled thoracic surgery
Key inclusion criteria (4 listed)
- Patient with a scheduled thoracic surgery
- ≥ 40 years
- Smoking cessation ≥ 1 month
- Smoking history ≥ 10 pack-year
Key exclusion criteria (4 listed)
- Subjects who received either chemiotherapy or radiotherapy
- Hypoxemia
- Body weight loss ≥ 10%
- Use of systemic corticosteroid in the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle biopsiesMuscle 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. | Procedure or surgery | COPD patients, Patients with normal lung function |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- Background: PubMed 24666540Theriault 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.
- Background: PubMed 22720047Theriault 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.
- Background: PubMed 19359618Caron 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Debigare, PhD, PT principal investigator
Laval University
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Laval University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle satellite cell proliferation index (time frame: Sequential analyses performed over a period of 2 weeks after tissue collection.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02557165, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.