NCT02532426|Terminated
Study Stopped
Lack of inclusion
Influence of Chronic Hypoxia on Oxidative Phenotype in Patients With Chronic Obstructive Pulmonary Disease
OXYPHEN
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Sponsor study identifier
Secondary identifiers
OTHER · AFSSAPS
observational
13
1 country
1
Study Start
May 18, 2012
Actual (reported)Primary Completion
September 30, 2017
Actual (reported)Study Completion
September 30, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 18, 2012
Actual (reported)August 21, 2015
Actual (reported)August 25, 2015
Actual (reported)September 30, 2017
Actual (reported)September 30, 2017
Actual (reported)Level of expression of muscle messenger ribonucleic acid (mRNA) of HIF-1α and PGC-1α
Comparison of expression levels of Hypoxia-inducible Factors (HIF-1α) and Peroxisome proliferator-activated receptor gamma, coactivator 1 alpha (PGC-1α), two OXYPHEN regulators, in muscle biopsy, between COPD patients with chronic hypoxemia and those with normoxemia
Day 1
Type I muscle fibers
Day 1
Oxidative enzyme capacity
Day 1
Level of expression of muscle mRNA of HIF-1α after acute exercise
Day 1
Level of expression of muscle mRNA of PGC-1α after acute exercise
Day 1
COPD patients with chronic and severe arterial hypoxemia at rest (paO2\<55mmHg).
COPD patients with normoxia at rest (paO2\>67mmHg), matched for age, sex, bronchial obstruction and lean mass.
The biopsy is performed on the vastus lateralis muscle at rest and 2 hours after an acute exercise, with a local anesthesia.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
COPD patients with chronic hypoxemia and with normoxemia
CHU de Saint-Etienne
Saint-Etienne, 42000, France
COSTES Frédéric, MD PhD
CHU de Saint-Etienne
13 participants (actual enrollment reported by the registry).
First Submitted
August 21, 2015
First Posted
August 25, 2015
Study Start
May 18, 2012
Actual (reported)The Six-minute Stepper Test as an Outcome Measure of Exercise Tolerance During Pulmonary Rehabilitation in With Chronic Obstructive Pulmonary Disease (COPD) Patients(STEPPER)?
Contact the study team to confirm eligibility.
Primary Completion
September 30, 2017
Actual (reported)Study Completion
September 30, 2017
Actual (reported)Last Updated
October 19, 2017
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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