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TerminatedNCT02532426OXYPHENUpdated Oct 19, 2017

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

An observational study in Chronic Obstructive Pulmonary Disease, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-19.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Why this study was terminated
Lack of inclusion
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
13
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • Chronic Obstructive Pulmonary Disease
  • Muscle biopsy
  • Chronic hypoxia
  • OXYPHEN
  • Oxydative phenotype
  • Exercise
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In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 13 is below the median of 157 across 929 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

COPD patients with chronic hypoxemia and with normoxemia

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

Exclusion Criteria:

  • Unstable cardiorespiratory status (acute respiratory failure)
  • Oxygen treatment started
  • Inclusion in a pulmonary rehabilitation program in the last 6 months
  • Anticoagulant treatment
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
13 participants (actual)
Patient registry
No

Groups and cohorts

  • COPD patients with chronic hypoxemia

    COPD patients with chronic and severe arterial hypoxemia at rest (paO2\<55mmHg).

    Procedure: Muscle biopsy

  • COPD patients with normoxia

    COPD patients with normoxia at rest (paO2\>67mmHg), matched for age, sex, bronchial obstruction and lean mass.

    Procedure: Muscle biopsy

Interventions

  • ProcedureMuscle biopsy

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 1

Secondary outcomes

  1. 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.

    Time frame: Day 1

  2. 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.

    Time frame: Day 1

  3. Level of expression of muscle mRNA of HIF-1α after acute exercise

    Comparison of response to acute exercise for expression level of HIF-1α (an OXYPHEN regulator) in muscle biopsy between the 2 groups.

    Time frame: Day 1

  4. Level of expression of muscle mRNA of PGC-1α after acute exercise

    Comparison of response to acute exercise for expression level of PGC-1α (an OXYPHEN regulator) in muscle biopsy between the 2 groups.

    Time frame: Day 1

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Study locations

1 site
  • CHU de Saint-Etienne
    Saint-etienne, 42000, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02532426
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
SYNAPSE assocation
Responsible party
Sponsor
First posted
Aug 25, 2015
Start date
May 18, 2012
Primary completion
Sep 30, 2017
Completion
Sep 30, 2017
Last update
Oct 19, 2017

Study contacts

COSTES Frédéric, MD PhD
principal investigator · CHU de Saint-Etienne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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