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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02903043
• Other study ID #: MIR-20895
• Status: Active, not recruiting
• Phase: N/A
• First received: April 9, 2015
• Last updated: May 9, 2017
• Start date: February 2013
• Est. completion date: February 2018

Study information

• Verified date: May 2017
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 2018
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Canadian Institutes of Health Research (CIHR), Fondation J-D Bégin de l'Université Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	miR-204 in limb muscles in patients with COPD	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	microRNAs in limb muscles of patients with COPD	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)