Exercise Capacity of Patients With Dermatomyosis

Dermatomyositis Clinical Trial

— MIDE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03293615
• Other study ID #: 6431
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2019
• Est. completion date: January 1, 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Alain Meyer, MD
• Phone: 00333 6 76 95 31 67
• Email: alain.meyer1[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatomyositis

Intervention

Other:
• exploration
Difference of the following parameters in patients i) with DM, ii) with another inflammatory myopathy iii) without neuromuscular disease.

Locations

Country	Name	City	State
France	Meyer	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	This difference in mitochondrial breathing capacity in the muscle will be achieved by: Muscle biopsy	Baseline