Metabolic MyopathyMatmixNCT05413681
Metabolomic Approach During Exercise Testing in Myalgia Induced by eXercise
A study testing a supra-maximal exercise test on a cycloergometer. and handgrip muscle activity test. in people with Metabolic Myopathy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Myopathy
- What is being tested?
- a supra-maximal exercise test on a cycloergometer. and handgrip muscle activity test.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2022to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU clermont-ferrand
Clermont-Ferrand
Lise Laclautre
Fabrice RANNOU
About this study
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).
Read the 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, including an interrogation on personal and family history and medication taken as well as a standard medical examination.
All subjects will be checked for compliance with the inclusion/exclusion criteria during this visit.
The subjects (patients and controls) will arrive in the morning on an empty stomach at the Sports Medicine Department of the Clermont-Ferrand University Hospital or at the Human Nutrition Unit for healthy volunteers. The subjects will be questioned about their personal and family history, about any medication they are taking, and their height and weight will be measured. The subjects will meet with a dietician to review their diet over the past 24 hours. A urine sample will be collected and divided into two aliquots: one for urinary organic acid chromatography (routine care) and one for storage for later metabolomics, transcriptomics and genomics.
Blood samples (n = 120) will be taken at the same times as during their usual care, before, during and during recovery from exercise: at rest, after the 3 maximal forearm contractions, at 1 minute of recovery from the 30-second grip-test contraction effort, before the exercise test on a cycloergometer, 2 samples during exercise on a cycloergometer (mid 'threshold' and peak of the effort), 2 samples during recovery from exercise on a cycloergometer (at 2 and 10 minutes), and 1 sample at 24 hours.
Patients will be offered to take this sample, 24 hours after the exercise test, at the Nutritional Testing Unit of the CRNH A or in their usual laboratory. If patients come to the Nutritional Testing Unit of the CRNH A for this blood test, the patients will be offered to measure their maximal muscular oxidative capacity (mVO2), using optical measurement of muscle oxygenation (near infrared spectroscopy, NIRS). If the patients do not return to the Nutritional Investigation Unit of the CRNH A for the 24-hour blood test, this measurement of maximal muscular oxidative capacity will be performed during their medical consultation to inform them of the results of their metabolic stress test (approximately 1 month later).
All the control subjects will have their blood taken at 24 hours after the exercise test at the Nutritional Investigation Unit of the CRNH A with, at the end, a measurement of their maximal muscular oxidative capacity (mVO2).
- Conditions
- Metabolic Myopathy
- Being tested
- a supra-maximal exercise test on a cycloergometer., handgrip muscle activity test.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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,
| Study group | Role | What they receive |
|---|---|---|
| metabolic myopathy | Active comparator | a supra-maximal exercise test on a cycloergometer. Receives: 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. Receives: Diagnostic Test: a supra-maximal exercise test on a cycloergometer.; Diagnostic Test: handgrip muscle activity test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours after effort test
Secondary outcomes (2)
Metabolomic response profile mesuring by mass spectrometer to a handgrip muscle activity test.
Subjects perform a first functional test, the grip-test. This test consists of an isometric contraction of the forearm muscles. The effort is standardized by asking the subject to perform a contraction at 70% of maximum. The subject performs three maximal contractions (5 seconds) of the forearm where the catheter is inserted, spaced with 1 minute of recovery. The best value is taken as the maximum voluntary contraction force (MVCF). After 5 minutes of rest, a blood sample is taken (to ensure that the 3 maximal contractions have not modified the metabolite concentrations) and then the subject performs a 30-second contraction at 70% MVCF.
Measured: Before grip-test
Metabolomic response profile mesuring by mass spectrometer to a handgrip muscle activity test.
Subjects perform a first functional test, the grip-test. This test consists of an isometric contraction of the forearm muscles. The effort is standardized by asking the subject to perform a contraction at 70% of maximum. The subject performs three maximal contractions (5 seconds) of the forearm where the catheter is inserted, spaced with 1 minute of recovery. The best value is taken as the maximum voluntary contraction force (MVCF). After 5 minutes of rest, a blood sample is taken (to ensure that the 3 maximal contractions have not modified the metabolite concentrations) and then the subject performs a 30-second contraction at 70% MVCF.
Measured: 5 minutes after grip-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start4 Oct 2022
- Primary completionAug 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic MyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice RANNOU, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413681
- Sponsor's protocol ID
- AOI 2020 RANNOU
- Other IDs
- 2020-A03296-33
- Acronym
- Matmix
- Status last verified
- Dec 2023
- First submitted
- 12 Apr 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Approach During Exercise Testing in Myalgia Induced by eXercise
- ClinicalTrials.gov ID
- NCT05413681
- Acronym / sponsor ID
- Matmix / AOI 2020 RANNOU
- Conditions
- Metabolic Myopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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, including an interrogation on personal and family history and medication taken as well as a standard medical examination.
All subjects will be checked for compliance with the inclusion/exclusion criteria during this visit.
The subjects (patients and controls) will arrive in the morning on an empty stomach at the Sports Medicine Department of the Clermont-Ferrand University Hospital or at the Human Nutrition Unit for healthy volunteers. The subjects will be questioned about their personal and family history, about any medication they are taking, and their height and weight will be measured. The subjects will meet with a dietician to review their diet over the past 24 hours. A urine sample will be collected and divided into two aliquots: one for urinary organic acid chromatography (routine care) and one for storage for later metabolomics, transcriptomics and genomics.
Blood samples (n = 120) will be taken at the same times as during their usual care, before, during and during recovery from exercise: at rest, after the 3 maximal forearm contractions, at 1 minute of recovery from the 30-second grip-test contraction effort, before the exercise test on a cycloergometer, 2 samples during exercise on a cycloergometer (mid 'threshold' and peak of the effort), 2 samples during recovery from exercise on a cycloergometer (at 2 and 10 minutes), and 1 sample at 24 hours.
Patients will be offered to take this sample, 24 hours after the exercise test, at the Nutritional Testing Unit of the CRNH A or in their usual laboratory. If patients come to the Nutritional Testing Unit of the CRNH A for this blood test, the patients will be offered to measure their maximal muscular oxidative capacity (mVO2), using optical measurement of muscle oxygenation (near infrared spectroscopy, NIRS). If the patients do not return to the Nutritional Investigation Unit of the CRNH A for the 24-hour blood test, this measurement of maximal muscular oxidative capacity will be performed during their medical consultation to inform them of the results of their metabolic stress test (approximately 1 month later).
All the control subjects will have their blood taken at 24 hours after the exercise test at the Nutritional Investigation Unit of the CRNH A with, at the end, a measurement of their maximal muscular oxidative capacity (mVO2).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| metabolic myopathy | Active comparator | Diagnostic Test: a supra-maximal exercise test on a cycloergometer., Diagnostic Test: handgrip muscle activity test.a supra-maximal exercise test on a cycloergometer. |
| Control : Healthy volonteers | Placebo comparator | Diagnostic Test: a supra-maximal exercise test on a cycloergometer., Diagnostic Test: handgrip muscle activity test.a supra-maximal exercise test on a cycloergometer. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a supra-maximal exercise test on a cycloergometer.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. | Diagnostic test | Control : Healthy volonteers, metabolic myopathy |
| handgrip muscle activity 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, | Diagnostic test | Control : Healthy volonteers, metabolic myopathy |
Primary outcome
Metabolomic response profile mesuring by mass spectrometer during a supra-maximal exercise test on a cycloergometer.
Time frame: Before effort test
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
Metabolomic response profile mesuring by mass spectrometer during a supra-maximal exercise test on a cycloergometer.
Time frame: during effort test
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
Metabolomic response profile mesuring by mass spectrometer during a supra-maximal exercise test on a cycloergometer.
Time frame: 2 minutes after effort test
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
Metabolomic response profile mesuring by mass spectrometer during a supra-maximal exercise test on a cycloergometer.
Time frame: 10 minutes after effort test
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
Metabolomic response profile mesuring by mass spectrometer during a supra-maximal exercise test on a cycloergometer.
Time frame: 24 hours after effort test
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 secondary outcomes
Metabolomic response profile mesuring by mass spectrometer to a handgrip muscle activity test.
Time frame: Before grip-test
Metabolomic response profile mesuring by mass spectrometer to a handgrip muscle activity test.
Time frame: 5 minutes after grip-test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice RANNOU principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a supra-maximal exercise test on a cycloergometer. and handgrip muscle activity test. in people with Metabolic Myopathy, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomic response profile mesuring by mass spectrometer during a supra-maximal exercise test on a cycloergometer. (time frame: Before effort test). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.