Metabolomic Approach During Exercise Testing in Myalgia Induced by eXercise

NCT05413681 | Unknown

• 2 other identifiers: AOI 2020 RANNOU2020-A03296-33
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Metabolic Myopathy

Outcome Measures

Primary Outcomes (5)

• Metabolomic response profile mesuring by mass spectrometer during a supra-maximal exercise test on a cycloergometer.

  blood samples will be taken : before the exercise test on the cycloergometer, 2 samples during exercise on the cycloergometer (middle of the threshold and peak of the exercise), 2 samples during recovery from exercise on the cycloergometer (at 2 and 10 minutes), and 1 sample at 24 hours

  Before effort test

• Metabolomic response profile mesuring by mass spectrometer during a supra-maximal exercise test on a cycloergometer.

  blood samples will be taken : before the exercise test on the cycloergometer, 2 samples during exercise on the cycloergometer (middle of the threshold and peak of the exercise), 2 samples during recovery from exercise on the cycloergometer (at 2 and 10 minutes), and 1 sample at 24 hours

  during effort test

• Metabolomic response profile mesuring by mass spectrometer during a supra-maximal exercise test on a cycloergometer.

  blood samples will be taken : before the exercise test on the cycloergometer, 2 samples during exercise on the cycloergometer (middle of the threshold and peak of the exercise), 2 samples during recovery from exercise on the cycloergometer (at 2 and 10 minutes), and 1 sample at 24 hours

  2 minutes after effort test

• Metabolomic response profile mesuring by mass spectrometer during a supra-maximal exercise test on a cycloergometer.

  blood samples will be taken : before the exercise test on the cycloergometer, 2 samples during exercise on the cycloergometer (middle of the threshold and peak of the exercise), 2 samples during recovery from exercise on the cycloergometer (at 2 and 10 minutes), and 1 sample at 24 hours

  10 minutes after effort test

• Metabolomic response profile mesuring by mass spectrometer during a supra-maximal exercise test on a cycloergometer.

  blood samples will be taken : before the exercise test on the cycloergometer, 2 samples during exercise on the cycloergometer (middle of the threshold and peak of the exercise), 2 samples during recovery from exercise on the cycloergometer (at 2 and 10 minutes), and 1 sample at 24 hours

  24 hours after effort test

Secondary Outcomes (2)

• Metabolomic response profile mesuring by mass spectrometer to a handgrip muscle activity test.

  Before grip-test

• Metabolomic response profile mesuring by mass spectrometer to a handgrip muscle activity test.

  5 minutes after grip-test

Study Arms (2)

metabolic myopathy

ACTIVE COMPARATOR

a supra-maximal exercise test on a cycloergometer.

Diagnostic Test: a supra-maximal exercise test on a cycloergometer.; Diagnostic Test: handgrip muscle activity test.

Control : Healthy volonteers

PLACEBO COMPARATOR

a supra-maximal exercise test on a cycloergometer.

Diagnostic Test: a supra-maximal exercise test on a cycloergometer.; Diagnostic Test: handgrip muscle activity test.

Interventions

a supra-maximal exercise test on a cycloergometer. DIAGNOSTIC_TEST

10 blood samples will be taken: before, during and during recovery from exercise: before the exercise test on the cycloergometer, 2 samples during exercise on the cycloergometer (middle of the threshold and peak of the exercise), 2 samples during recovery from exercise on the cycloergometer (at 2 and 10 minutes), and 1 sample at 24 hours.

Control : Healthy volonteers; metabolic myopathy

handgrip muscle activity test. DIAGNOSTIC_TEST

2 bloods samples : at rest, after the 3 maximum contractions of the forearm, at 5 minute's recovery from the 30-second contraction of the grip test,

Control : Healthy volonteers; metabolic myopathy

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• For healthy subjects:
• Refusal of registration in the national 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

Study Officials

• Fabrice RANNOU

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective study in two arms: a group of patients referred for metabolic exploration during exercise as part of their care and a group of control subjects who will perform the same explorations as the patients.

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: June 10, 2022
• Study Start: October 4, 2022
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

FR (1)