Expression of miR-204 and Consequences on Capillarization in Limb Muscles of Patients With COPD

May 9, 2017 updated by: Annie Dubé, Laval University

Expression of miR-204 and Consequences on Capillarization in Limb Muscles of Patients With Chronic Obstructive Pulmonary Disease

Limb muscle dysfunction, characterized by loss of capillaries, is amongst the most troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to poor functional status and premature mortality.

One prevailing hypothesis stipulates that modification in the expression of miR-204 leads to change the regulation of angiogenesis in vastus lateralis of patients with COPD when compared to controls.

Study Overview

Status

Unknown

Conditions

Detailed Description

The investigators objective is to investigate the impact of COPD on key signaling pathways involved in the muscle angiogenesis. Mild to severe COPD patients and healthy controls will be recruited. All of the investigators patients will undergo a thorough baseline assessment in pulmonary capacity and body composition. Blood sampling and biopsy of the quadriceps will be done. Key proteins and microRNAs of signaling intramuscular pathways involved in angiogenesis will be measured in the quadriceps.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Institut universitaire de Cardiologie et de Pneumologie de Quebec

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with COPD

Description

Inclusion Criteria:

  • COPD (FEV1/FVC < 0.70)
  • Healthy subjects: no evidence of airways obstruction (FEV1/FVC > 0.70 and FEV1 > 0.80 predicted)
  • Smoking history > 10 pack-years
  • Ex-smoker >6 months

Exclusion Criteria:

  • Chronic hypoxemia and/or hypercapnia (PaO2 < 60 mmHg or SpO2 < 88% at rest and/or PaCO2 > 45 mmHg)
  • Recent exacerbation or oral corticosteroids (< 2 months)
  • Recent cancer (< 3 years)
  • Diabetes
  • Myopathy, neuromuscular, neurological or articular diseases
  • Kidney disease
  • Other respiratory diseases
  • Unstable cardiac disease
  • Physical activity score > 9 in the Voorips questionnaire
  • BMI > 30

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
COPD patients
Quadriceps biopsies will be done. No drug administration.
Healthy controls
Quadriceps biopsies will be done. No drug administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
miR-204 in limb muscles in patients with COPD
Time Frame: At baseline (COPD patients in a stable state of the disease)

i)To measure miR-204 level in the quadriceps of patients with COPD in comparison to controls.

ii) To study possible involvement of miR-204 on pathways regulating angiogenesis and on muscle microcirculation in these individuals.
At baseline (COPD patients in a stable state of the disease)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
microRNAs in limb muscles of patients with COPD
Time Frame: At baseline (COPD patients in a stable state of the disease)

i) To measure microRNAs levels in the quadriceps of patients with COPD in comparison to controls.

ii) To study possible involvement of these microRNAs on pathways regulating myogenesis, angiogenesis and on muscle microcirculation in these individuals.
At baseline (COPD patients in a stable state of the disease)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Study Director: François Maltais, MD, Laval University

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

February 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

April 9, 2015

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIR-20895

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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