Status:
UNKNOWN
Metabolomic Approach During Exercise Testing in Myalgia Induced by eXercise
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Metabolic Myopathy
Eligibility:
All Genders
15+ years
Phase:
NA
Brief Summary
Metabolic myopathies form a group of pathologies related to a deficit of muscle energy production (enzymatic deficit) by disorder of the metabolism of carbohydrates, lipids, purines, or mitochondrial ...
Detailed Description
Patients will be pre-selected on the basis of their medical records and control subjects will be subjected, after signing the consent form, to a medical check-up, carried out at one of the study sites...
Eligibility Criteria
Inclusion
- For patients:
- Patient, male or female, adult or minor aged 15 years or more, referred to the Sports Medicine Department of the Clermont-Ferrand University Hospital for metabolic exploration during exercise, as part of the diagnostic work-up for one of the following clinical contexts:
- Suspicion of metabolic myopathy
- Cramps, contractures or myalgias during or after exercise
- Exercise intolerance/fatigability without obvious cause (cardiac and/or respiratory etiology in particular)
- Episode of malignant hyperthermia or rhabdomyolysis during exercise
- Unexplained elevation of CPK
- For healthy subjects:
- Major subject, male or female, 18 to 50 years old.
- No chronic pathology
- No treatment (background or at the time of the examination)
- Non-smoker
- No/little alcohol consumption (\<5 glasses/week), no consumption in the 48 hours before the stress test
- Non/little athletic (\<2h of strenuous physical activity/week), no physical activity the day before and the day of (pre- and post-test)
- For all participants:
- Able to give informed consent to participate in the research
- For minor patients, consent from the holders of parental authority
- Affiliation to the French Social Security system
Exclusion
- For healthy subjects:
- Refusal of registration in the national file of volunteers for research involving the human person.
- Subject in a period of exclusion from a previous study or having received a total amount of compensation greater than 4500 euros over the 12 months preceding the start of the trial (after verification in the File of Volunteers for Research Involving the Human Person).
- For all participants:
- Contraindications to an exercise test on a cycloergometer, mainly cardiorespiratory (ATS/ACCP statement on cardiopulmonary exercise testing. Am J Respi Care Med. 2003;167:211-77.)
- Pregnant women (a pregnancy test will be performed on all participants of childbearing age on the day the exercise tests are performed) and nursing mothers.
- Refusal to sign the consent form.
- Patients under guardianship, curatorship, deprived of liberty or safeguard of justice.
Key Trial Info
Start Date :
October 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05413681
Start Date
October 4 2022
End Date
September 1 2025
Last Update
December 11 2023
Active Locations (1)
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1
CHU clermont-ferrand
Clermont-Ferrand, France