MIDE: Exercise Capacity of Patients With Dermatomyosis

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT03293615
Collaborator
(none)
45
1
3
61.1
0.7

Study Details

Study Description

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
  • Other: exploration
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
Nov 28, 2019
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

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

Outcome Measures

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. [Baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

  1. normal neuromuscular examination, iii) no increase in blood creatine kinase level,
  2. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Meyer Strasbourg France 67000

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Alain Meyer, Les Hôpitaux Universitaires de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT03293615
Other Study ID Numbers:
  • 6431
First Posted:
Sep 26, 2017
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
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:

Study Results

No Results Posted as of Aug 19, 2022