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

NCT02532426 | Terminated

• 2 other identifiers: 11081002011-A00856-35
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Muscle biopsy; Chronic hypoxia; OXYPHEN; Oxydative phenotype; Exercise

Outcome Measures

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

  Day 1

Secondary Outcomes (4)

• 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

Study Arms (2)

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

Muscle biopsy PROCEDURE

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

COPD patients with chronic hypoxemia; COPD patients with normoxia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients with chronic hypoxemia and with normoxemia

You may qualify if:

• Diagnosis of COPD confirmed according to GOLD score.
• Hypoxemia group: resting arterial paO2 \<55 mmHg.
• Normoxemia group : resting arterial paO2 \> 67 mmHg

You may not qualify if:

• Unstable cardiorespiratory status (acute respiratory failure)
• Oxygen treatment started
• Anticoagulant treatment

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• SYNAPSE assocation: collaborator

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• COSTES Frédéric, MD PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 25, 2015
• Study Start: May 18, 2012
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)