Influence of Chronic Hypoxia on Oxidative Phenotype in Patients With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

— OXYPHEN  

Official title:

Influence of Chronic Hypoxia on Oxidative Phenotype in Patients With Chronic Obstructive Pulmonary Disease

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
• 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

Related Conditions & MeSH terms

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

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