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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02903043
Other study ID # MIR-20895
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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