Metabolic MyopathiesRANNOUNCT02362685
Metabolic Exercise Testing
An observational study of Metabolic Myopathies and Exercise Test, run by University Hospital, Brest at 1 site in France.
Trial summary
Exertional symptoms are the hallmarks of metabolic myopathies, supporting the concept of using functional tests when this diagnosis is suspected. Exercise increases the concentration of muscle metabolites in the venous blood supply (e.g. lactate, pyruvate, and ammonia) especially during recovery. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Myopathies, Exercise Test, Myalgia
- What is being tested?
- functional test and matching genotype with phenotype
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects referred to perform a metabolic exercise testing.
Who may be able to join
- Referred to the Physiology Department of Brest Hospital for a metabolic exercise test
- Ability to provide informed consent
Who cannot join
- Contraindication(s) to perform cardiopulmonary exercise testing (ATS/ACCP statement on cardiopulmonary exercise testing, Am J respi Care Med 167: 211-77, 2003)
- Pregnancy or unknown pregnancy status.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Régional Universitaire
Brest, 29609
Fabrice Rannou, MD, PhD, 33(0)298347366, fabrice.rannnou@univ-brest.fr
About this study
Official title: Exercise Testing in Metabolic Myopathies
Exertional symptoms are the hallmarks of metabolic myopathies, supporting the concept of using functional tests when this diagnosis is suspected. Exercise increases the concentration of muscle metabolites in the venous blood supply (e.g. lactate, pyruvate, and ammonia) especially during recovery. The purpose of this study is to compare the results of exercise testing with to the data from muscle biopsy or genetic analysis.
- Conditions
- Metabolic Myopathies, Exercise Test, Myalgia
- Being tested
- functional test, matching genotype with phenotype
- Keywords
- Metabolic myopathies, Exercise testing, Blood sample, Muscle biopsy, Genetic analysis, Cycloergometer, Grip-test, Exercise physiology, Muscle physiology
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional testDevice
subjects perform a metabolic exercise testing
matching genotype with phenotypeGenetic
| Study group | Role | What they receive |
|---|---|---|
| metabolic exercise testing | All the subjects referred to performed a metabolic exercise testing. Receives: Device: functional test; Genetic: matching genotype with phenotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body dynamic exercise
The relation between Cardiopulmonary exercise test variables and the results of muscle biopsy or genetic analysis will be evaluated.
Measured: Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
Grip-test
The relation between Grip-test variables and the results of muscle biopsy or genetic analysis will be evaluated.
Measured: Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
Blood tests
The results of blood analysis from samples performed before, during, and after exercise will be compared to the results of muscle biopsy or genetic analysis.
Measured: Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startSep 2008
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic MyopathiesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RANNOU, University Hospital, Brest
- Investigators
- Fabrice Rannou, MD, PhD, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362685
- Sponsor's protocol ID
- RANNOU
- Acronym
- RANNOU
- Status last verified
- Jan 2020
- First submitted
- 4 Feb 2015
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Testing in Metabolic Myopathies
- ClinicalTrials.gov ID
- NCT02362685
- Acronym / sponsor ID
- RANNOU / RANNOU
- Conditions
- Metabolic Myopathies, Exercise Test, Myalgia
- Keywords
- Metabolic myopathies, Exercise testing, Blood sample, Muscle biopsy, Genetic analysis, Cycloergometer, Grip-test, Exercise physiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Feb 2015 (estimated)
- 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.
Exertional symptoms are the hallmarks of metabolic myopathies, supporting the concept of using functional tests when this diagnosis is suspected. Exercise increases the concentration of muscle metabolites in the venous blood supply (e.g. lactate, pyruvate, and ammonia) especially during recovery. The purpose of this study is to compare the results of exercise testing with to the data from muscle biopsy or genetic analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metabolic exercise testing | – | Device: functional test, Genetic: matching genotype with phenotypeAll the subjects referred to performed a metabolic exercise testing. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects referred to perform a metabolic exercise testing.
Key inclusion criteria (2 listed)
- Referred to the Physiology Department of Brest Hospital for a metabolic exercise test
- Ability to provide informed consent
Key exclusion criteria (2 listed)
- Contraindication(s) to perform cardiopulmonary exercise testing (ATS/ACCP statement on cardiopulmonary exercise testing, Am J respi Care Med 167: 211-77, 2003)
- Pregnancy or unknown pregnancy status.
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 |
|---|---|---|
| functional testsubjects perform a metabolic exercise testing | Device | metabolic exercise testing |
| matching genotype with phenotype | Genetic | metabolic exercise testing |
Primary outcome
Whole-body dynamic exercise
Time frame: Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
The relation between Cardiopulmonary exercise test variables and the results of muscle biopsy or genetic analysis will be evaluated.
Grip-test
Time frame: Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
The relation between Grip-test variables and the results of muscle biopsy or genetic analysis will be evaluated.
Blood tests
Time frame: Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
The results of blood analysis from samples performed before, during, and after exercise will be compared to the results of muscle biopsy or genetic analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
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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.
Fabrice Rannou, MD, PhD principal investigator
CHRU BREST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Myopathies and Exercise Test, run by University Hospital, Brest 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 Jan 2020. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrice Rannou, MD, PhD (33(0)298347366, fabrice.rannou@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-body dynamic exercise (time frame: Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed). The study lists 3 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 22 Jan 2020.