Exercise Capacity of Patients With Dermatomyosis (MIDE)

August 16, 2024 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67000
        • Recruiting
        • Meyer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2019

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

September 15, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 26, 2017

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 16, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6431

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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