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Exercise Capacity of Patients With Dermatomyosis (MIDE)

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ClinicalTrials.gov Identifier: NCT03293615
Recruitment Status : Not yet recruiting
First Posted : September 26, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


Condition or disease Intervention/treatment Phase
Dermatomyositis Other: exploration Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exercise Capacity of Patients With Dermatomyosisthe Role of Muscle Mitochondria and Reactive Oxygen Species
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : January 1, 2025


Arm Intervention/treatment
Experimental: Dermatomyositis (DM)
Patients with dermatomyositis according to ENMC criteria
Other: exploration
Difference of the following parameters in patients i) with DM, ii) with another inflammatory myopathy iii) without neuromuscular disease.

Active Comparator: Non-dermatomyositis inflammatory myopathies
Patients with other inflammatory myopathy than dermatomyositis according to ENMC criteria
Other: exploration
Difference of the following parameters in patients i) with DM, ii) with another inflammatory myopathy iii) without neuromuscular disease.

No Intervention: No myopathy
Patients without myopathy on muscle biopsy



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293615


Contacts
Contact: Alain Meyer, MD 00333 6 76 95 31 67 alain.meyer1@chru-strasbourg.fr
Contact: Alain Alain, MD 00333 6 76 95 31 67 alain.meyer1@chru-strasbourg.fr

Sponsors and Collaborators
University Hospital, Strasbourg, France

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03293615     History of Changes
Other Study ID Numbers: 6431
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases