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Exercise Capacity of Patients with Dermatomyosis

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03293615
Acronym
MIDE
Enrollment
3
Registered
2017-09-26
Start date
2019-11-28
Completion date
2024-09-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatomyositis

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.

Interventions

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

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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.BaselineThis difference in mitochondrial breathing capacity in the muscle will be achieved by: Muscle biopsy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026