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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02532426
Other study ID # 1108100
Secondary ID 2011-A00856-35
Status Terminated
Phase N/A
First received August 21, 2015
Last updated October 17, 2017
Start date May 18, 2012
Est. completion date September 30, 2017

Study information

Verified date October 2017
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In addition to chronic airflow obstruction, patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from skeletal muscle dysfunction which is a prominent and disabling feature and also an independent determinant of survival. Muscular impairment involves loss of muscle oxidative phenotype (OXPHEN: a slow-to-fast shift in fibre types and reduced oxidative capacity). Since hypoxia obviously is a key feature of COPD, the aim of this study is to elucidate the role of hypoxia in loss of muscle OXPHEN.

Thus, OXPHEN and expression levels of its key regulators will be determined in the baseline biopsies for association with the degree of hypoxemia. In addition, expression levels of the key OXPHEN regulators will be measured in pre/post exercise biopsies.


Recruitment information / eligibility

Status Terminated
Enrollment 13
Est. completion date September 30, 2017
Est. primary completion date September 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of COPD confirmed according to GOLD score.

- Hypoxemia group: resting arterial paO2 <55 mmHg.

- Normoxemia group : resting arterial paO2 > 67 mmHg

Exclusion Criteria:

- Unstable cardiorespiratory status (acute respiratory failure)

- Oxygen treatment started

- Inclusion in a pulmonary rehabilitation program in the last 6 months

- Anticoagulant treatment

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Muscle biopsy
The biopsy is performed on the vastus lateralis muscle at rest and 2 hours after an acute exercise, with a local anesthesia.

Locations

Country Name City State
France CHU de Saint-Etienne Saint-etienne

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne SYNAPSE assocation

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of expression of muscle messenger ribonucleic acid (mRNA) of HIF-1a and PGC-1a Comparison of expression levels of Hypoxia-inducible Factors (HIF-1a) and Peroxisome proliferator-activated receptor gamma, coactivator 1 alpha (PGC-1a), two OXYPHEN regulators, in muscle biopsy, between COPD patients with chronic hypoxemia and those with normoxemia Day 1
Secondary Type I muscle fibers It is an indicator of the muscle phenotype (with a muscle biopsy). It used to compared the muscle phenotype in the 2 groups of patients. It is a percentage. Day 1
Secondary Oxidative enzyme capacity It is an other indicator of the muscle phenotype (with a muscle biopsy). It used to compared the muscle phenotype in the 2 groups of patients. Day 1
Secondary Level of expression of muscle mRNA of HIF-1a after acute exercise Comparison of response to acute exercise for expression level of HIF-1a (an OXYPHEN regulator) in muscle biopsy between the 2 groups. Day 1
Secondary Level of expression of muscle mRNA of PGC-1a after acute exercise Comparison of response to acute exercise for expression level of PGC-1a (an OXYPHEN regulator) in muscle biopsy between the 2 groups. Day 1
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