Informations générales (source: ClinicalTrials.gov)

NCT05413681 En recrutement
Metabolomic Approach During Exercise Testing in Myalgia Induced by eXercise (Matmix)
Interventional
  • Myalgie
N/A
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
octobre 2022
septembre 2025
29 juin 2024
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 involvement related to dysfunction of complex respiratory chain. Most often, the symptomatology may include signs of "muscular" calling with cramps, contractures or exercise myalgia, more or less associated with exercise intolerance with early fatigability and rhabdomyolysis. In practice, the clinical signs are not specific and not pathognomonic, or sometimes absent with only an isolated elevation of the CPK. The diagnosis of certainty is usually based on the realization of a muscle biopsy (invasive). Unfortunately, the performance of the biopsy (definitive diagnosis of myopathy) in front of myalgia is low, hence the interest of functional explorations upstream to better specify its indication. Given the considerable increase in muscle metabolism to physical effort, resting investigations may not uncover myo-metabolic deficit. The muscle enzymatic deficit, is therefore most often "silent" at rest and its highlighting requires to explore the patient with effort, asking him to perform an exercise test on cycloergometer and/or an isometric contraction of the forearm ('handgrip test'). Currently, only a few metabolites are dosed before and after exertion such as lactate, pyruvic acid and ammonium. Several studies in normal subjects showed the effect of physical exercise on the metabolomic signature of plasma. Our aim is to apply modern metabolomic techniques to plasma and urinary samples collected as part of the care pathway in patients referred to in the Department of Sports Medicine-Functional Explorations of the CHU in comparison with healthy volunteers).
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU clermont-ferrand - Clermont-Ferrand - France Lise Laclautre En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

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



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.