Involvement of Skeletal Muscle Fibrocytes in sarcOpenia in Patients With Chronic ObstRuctive Pulmonary Disease

NCT04939454 | Completed

• 1 other identifier: CHUBX 2020/50
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is presently the third leading cause of death worldwide and is characterized by irreversible airflow limitation diagnosed by spirometry. COPD is currently considered as a systemic disease with predominantly respiratory involvement, associated with numerous comorbidities. Among these, muscle wasting, present in about one third of patients, is associated with a higher mortality (up to 10-fold, irrespective of the severity of the obstruction). Muscle wasting is classically characterized by a decrease in muscle strength and volume (sarcopenia), which can be defined by a decrease in the muscle mass measured by dual X-ray absorptiometry: Appendicular Skeletal Muscle Mass or ASM / height \< 7.0 kg/m2 in men and 5.5 kg/m2 in women. However, sarcopenia is largely underestimated in current clinical practice. Moreover, there is no specific treatment: only exercise training as part of respiratory rehabilitation has shown some efficiency. The underlying pathophysiological mechanisms are indeed poorly characterized. Fibrocytes, cells derived from blood monocytes and able to migrate to different organs in order to play pro-fibrotic or pro-inflammatory roles, play a key role in bronchial obstruction. They are recruited in the blood of COPD patients during an acute exacerbation according to a CXCL12/CXCR4 chemotactic axis. Their role in COPD sarcopenia is currently unknown, but recent data show that they are involved in a mouse model of muscular dystrophy. The hypothesis is that fibrocytes are involved in COPD sarcopenia.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Fibrocytes density (number/mm2) in quadricipital biopsies of sarcopenic patients versus non-sarcopenic patients

  Fibrocytes density (number/mm2) in quadricipital biopsies of sarcopenic patients versus non-sarcopenic patients

  Day 14

Secondary Outcomes (4)

• Mesure of appendicular skeletal muscle mass index (kg/m2)

  Day 7

• Distance covered in 6 minutes (meters)

  Day 7

• Maximum grip forces with hand dynamometer in kg

  Day 7

• Average of the maximum forces developed in isokinetic dynamometry for the quadriceps in N.m-1

  Day 7

Study Arms (2)

sarcopenic COPD patient

EXPERIMENTAL

Procedure: quadricipital biopsy

non-sarcopenic COPD patient

OTHER

Procedure: quadricipital biopsy

Interventions

quadricipital biopsy PROCEDURE

The primary endpoint will be evaluated by histological examination only. The technique of percutaneous biopsy using the modified Bergström needle technique is currently considered the best alternative in the context of research, as it allows sufficient material to be obtained for various analyses and is much less invasive than the reference technique (surgical biopsy). Indeed, unlike surgical biopsy which requires an operating room and is a relatively heavy procedure (two suture planes, skin incision of several centimeters, resting for 48 hours after the procedure...), percutaneous biopsy by the modified Bergström technique can be performed in a consultation room, requires only one stitch, and allows resumption of walking 30 minutes after the end of the procedure.

non-sarcopenic COPD patient; sarcopenic COPD patient

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women 40 years of age or older;
• Diagnosed with COPD according to the 2018 Global Initiative for Lung Disease (GOLD) criteria:
• Smoking intoxication greater than or equal to 10 pack-years
• Bronchial obstruction on spirometry with a FEV1 to FVC ratio post-bronchodilator \< 70%.
• Available measurement of lean body mass by bioelectrical impedancemetry performed as part of routine care;
• Insured under the French social security system;
• The patients included will be sarcopenic and non-sarcopenic (equal numbers in each group, patients categorized according to the result of dexametry), and will be matched on sex and age (± 5 years).

You may not qualify if:

• Other concomitant respiratory pathology (e.g., asthma);
• Acute exacerbation of COPD or acute intercurrent condition (e.g. infection) ongoing or resolved within the last 48 hours
• Current systemic corticosteroid therapy;
• Contraindication to muscle biopsy: acquired or innate hemostasis disorders, anticoagulant therapy or double anti-platelet aggregation; contraindication to lidocaine: known hypersensitivity, patients with recurrent porphyrias;
• Presence of a concomitant muscular pathology, innate (e.g. genetic myopathy) or acquired (e.g. myositis);
• Progressive bronchopulmonary cancer;
• Pregnant or breast-feeding woman;
• Patient undergoing respiratory rehabilitation;
• Refusal to participate in the study.
• Disorders of hemostasis detected on the blood sample;
• Pregnancy in progress.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Hôpital Haut-Lévêque - CHU de Bordeaux

Pessac, 33600, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Pauline HENROT, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an observational, etiological, cross-sectional case-control type, monocentric, multi-departmental study.

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 25, 2021
• Study Start: November 29, 2022
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)