Metabolomic analysis during exercise for muscle pain diagnosis

Metabolomic Approach During Exercise Testing in Myalgia Induced by eXercise

This study is testing how exercise affects muscle metabolism in people who might have muscle energy problems to see if it can help doctors diagnose these conditions better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 15 Years and up
• Sex: All
• Sponsor: University Hospital, Clermont-Ferrand (Academic / other)
• Locations: 1 site (Clermont-Ferrand)
• Trial ID: NCT05413681 on ClinicalTrials.gov

What this trial studies

This study investigates metabolic myopathies, which are conditions that impair muscle energy production and can lead to symptoms like cramps and exercise intolerance. Patients suspected of having these conditions will undergo a series of exercise tests, including a cycloergometer test and handgrip muscle activity assessments. Blood and urine samples will be collected to analyze metabolic profiles and help refine diagnostic approaches. The goal is to improve the understanding of muscle metabolism during exercise and enhance diagnostic accuracy without invasive procedures.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 15 and older with symptoms suggestive of metabolic myopathy or unexplained muscle pain during exercise.

Not a fit: Patients with chronic pathologies unrelated to muscle metabolism or those currently undergoing treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and less invasive diagnostic methods for metabolic myopathies.

How similar studies have performed: While the approach of using metabolomics in exercise testing is gaining interest, this specific methodology for diagnosing metabolic myopathies is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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

Exclusion Criteria:

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.

Where this trial is running

Clermont-Ferrand

• CHU clermont-ferrand — Clermont-Ferrand, France (Recruiting)

Study contacts

• Principal investigator: Fabrice RANNOU — University Hospital, Clermont-Ferrand
• Study coordinator: Lise Laclautre

Conditions Metabolic Myopathy