Involvement of Plasmatic Factors in the Peripheral Muscle Dysfunction of COPD Patients - In Vitro Study

Chronic Obstructive Pulmonary Patients is a defined by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. It is associated with an atrophy of the skeletal muscle that impairs the patient's prognosis. The biological mechanisms of this muscle atrophy have not been elucidated, and the "spill-over theory" has recently emerged. Indeed, in COPD patients, the pulmonary inflammation is associated with a systemic low-grade inflammation, and the increased pro-inflamatory molelcules in the blood - which constitute the cellular micro-environement of the muscle fibre - could activate the mechanisms of the cell atrophy.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary
• Intervention / Treatment: Other: Determination of pro-inflammatory plasma factors

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34290
    • UHMontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic Obstructive Pulmonary Patients

Description

Inclusion Criteria:

35 to 85 years old

• COPD patients: association of symtoms (breathlessness, cough, sputum) and chronic exposure to inhalated risk factors (like tobacco smoke) and a FEV1/VC ratio <70% assessed by a spirometry
• Healthy subjects: A sedentariness assessed by a Voorrips score <9.4 and/or a report of <150 min/week of moderate-to-vigorous physical activity

Exclusion Criteria:

• A recent COPD exacerbation (< 4weeks)
• The decompensation of a comorbidity
• An antioxidant supplementation or medication
• A long-term systemic corticosteroid medication

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects; Determination of pro-inflammatory plasma factors at Healthy subjects aged from 35 to 85 years old	Other: Determination of pro-inflammatory plasma factors; Determination of pro-inflammatory plasma factors at COPD patients aged from 35 to 85 years old and Healthy subjects aged from 35 to 85 years old
COPD patients; Determination of pro-inflammatory plasma factors at COPD patients aged from 35 to 85 years old	Other: Determination of pro-inflammatory plasma factors; Determination of pro-inflammatory plasma factors at COPD patients aged from 35 to 85 years old and Healthy subjects aged from 35 to 85 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myotube diameter of in vitro cultured myotubes	Myotube diameter of in vitro cultured myotubes from healthy subjects, exposed to the serum of healthy controls and COPD patients	6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression and translation of markers of	Expression and translation of markers of anabolic and catabolic pathways	6 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of pro-Inflamatory markers	Level of pro-Inflamatory markers in the serum	6 days

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Maurice HAYOT, MD, PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: systemic inflammation; COPD (Chronic Obstructive Pulmonary Patients); Atrophy; cell cultur; Catabolism
• Other Study ID Numbers: RECHMPL17_0210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No