Exercise Capacity of Patients With Dermatomyosisthe Role of Muscle Mitochondria and Reactive Oxygen Species

University Hospital, Strasbourg, France1 site in 1 country45 target enrollmentNovember 28, 2019

ConditionsDermatomyositis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dermatomyositis
Sponsor: University Hospital, Strasbourg, France
Enrollment: 45
Locations: 1
Primary Endpoint: Difference in the capacity of muscle fibers to consume oxygen in the muscle of patients i) with DM, ii) with other inflammatory myopathy, iii) without neuromuscular disease.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Dermatomyositis (DM) patients experience muscle weakness and low aerobic capacities, which are associated with poor health status and increased mortality. The origin of this muscle impairment remains unknown.

The investigators hypothesize that mitochondria functioning is impaired in DM muscle and links with exercise capacities.

Registry

clinicaltrials.gov

Start Date

November 28, 2019

End Date

January 1, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Strasbourg, France

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Woman or man\> 18 years,
•Signature of informed consent,
•Muscle biopsy for suspicion of recent inflammatory myopathy (\<6 months) or for exclusion of neuromuscular pathology.
•Prospectively, following the results of the muscle biopsy, the subjects will divided into three groups meeting the following criteria:
•"DM" group: DM according to the ENMC criteria;
•"other inflammatory myopathy" group: polymyositis, autoimmune necrotizing myopathy, non-specific myositis or inclusion myositis according to the ENMC criteria;
•Group "no neuromuscular pathology": i) myalgia and / or intolerance to exercise and ii) normal neuromuscular examination, iii) no increase in blood creatine kinase level, iv) absence of electromyographic abnormality, v) histological Muscle mass.

Exclusion Criteria

•- Taking an immunomodulatory treatment within 6 months before inclusion,
•Paraneoplastic form of the disease,
•Presence of associated interstitial pneumonitis,
•Neuromuscular pathology different from inflammatory myopathy,
•Unbalanced cardiovascular disease,
•Impossibility of giving the subject informed information (subject in an emergency situation, difficulty in understanding the subject, ...),
•Subject under safeguard of justice,
•Subject under tutelage or under curators,
•Pregnancy (positive pregnancy test)
•Breastfeeding.

Outcomes

Primary Outcomes

Difference in the capacity of muscle fibers to consume oxygen in the muscle of patients i) with DM, ii) with other inflammatory myopathy, iii) without neuromuscular disease.

Time Frame: Baseline

This difference in mitochondrial breathing capacity in the muscle will be achieved by: Muscle biopsy