Muscle InjuryCareStressNCT05279196
Biological Variables Associated With the Response to Intensive Training in Athletes
A study testing Quadriceps microbiopsy and blood collection in people with Muscle Injury, run by University Hospital, Montpellier at 1 site in France.
Trial summary
There is in humans, at the muscular level, a great interindividual variability in response to the same mechanical stress. This phenotypic variability is multifactorial, influenced by environmental factors as well as multiple genetic variants. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Injury
- What is being tested?
- Quadriceps microbiopsy and blood collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Mar 2029
- Phase
- Interventional
- 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 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Senior male athlete aged between 40 and 60 inclusive
- Athlete following a program over a season of muscle building at CREPS, the objective of which is to improve their performance in a middle-distance race.
Who cannot join
- Subject having a contraindication to follow the complete muscle building program at CREPS with in particular a contraindication to the measurement of muscle mass by Magnetic Resonance Imaging
- Subject presenting all criteria which can by themselves alter the function of the respiratory muscles such as chronic obstructive pulmonary disease, heart failure, systemic infection, neuromuscular pathology, psychiatric pathology, metabolic disorder.
- Subjects with coagulopathy or thrombocytopenia.
- Use of anabolic drugs to increase muscle mass
- Subject suspected of doping
- Subject allergic to xylocaine
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
University Hospital
Montpellier, 34295
Stephan MATECKI, MD-PhD, 467335908 ext. 33, stephan.matecki@umontpellier.fr
About this study
Official title: Biological Variables Associated With the Response to Intensive Training in Athletes (CareStress)
There is in humans, at the muscular level, a great interindividual variability in response to the same mechanical stress. This phenotypic variability is multifactorial, influenced by environmental factors as well as multiple genetic variants. Thus, for the same level of muscle damage, two subjects with the same anthropometric characteristic, the same age, with the same medical history and the same level of physical activity, will present a variable level of muscle regeneration underpinned by the biological function of muscular stem cells and their microenvironment. Thus, faced with the same training, some athletes will develop iterative muscular lesions and more disabling repair deficits than others without knowing the reason of this greater susceptibility.
Indeed, the links between the genotype of the skeletal muscle fiber and its response to exercise, as well as the regulation of muscle mass are poorly understood. Yet, in young adults, up to 70% of the observed variability in muscle strength and size is hereditary. This heritability of muscle size and strength seems to be lower in older people, probably related to increased comorbidity. Numerous experiments with athletes subjected to the same resistance exercise training have identified good and bad hypertrophic skeletal muscle responders. However, genetic variants that contribute to skeletal muscle strength and mass are largely understudied while a growing body of evidence indicates that epigenetic effectors, which modulate gene expression, may contribute to human muscle response heterogeneity to the same mechanical stress. Thus, to date, no analysis of the role of the interaction between genetic and epigenetic factors involved in the muscle functional response to exercise exists. The main hypothesis is that the epigenetic status of muscle stem cells (satellite cells) is an important contributor in muscle mass response to exercise by modulating chromatin architecture.
Thus this study will identify the epigenetic modifications induced by training and their interaction with the genetic factors involved in the response of the biological function of the satellite cells to this training and on the other hand, to be able to link it to a blood signature.
Read the detailed description
The study will be carried out in close collaboration with the Director of the Expertise and Sports Performance Center (CREPS) of Montpellier. Compared to the athlete's usual seasonal training program, his participation in research will be limited to two visits to the Montpellier University Hospital where a quadriceps micro biopsy and a blood test will be carried out. During the first visit to the Montpellier University Hospital, a short clinical examination will also be carried out including an interrogation on his medical history, his consumption of drugs, alcohol, tobacco as well as the measurement of his weight and height and a simple cardiopulmonary auscultation. As part of the standard care for athletes, the training program carried out at CREPS Montpellier will be defined by weekly strength exercises to increase muscle mass. As part of this program and approximately one week before the two visits to the Montpellier University Hospital, an evaluation of the mass and the contractile function of the muscle will be carried out. The measurement of muscle mass will be carried out by Magnetic Resonance Imaging. The contractile function of the quadriceps muscle will be measured on a weight bench equipped with a dynamometer at the CREPS in Montpellier. Data from these assessments will be collected as part of the research.
This study will allow the synthesis of a muscular organoid, representative of an in vivo muscle, allowing the in vitro study of muscular lesions associated with the rupture of muscle fibres and the activation of satellite cells allowing the regeneration of damaged fibres. This in vitro muscle model will allow us to evaluate the inter-individual variability of the muscle response to the same mechanical stress and to study its link with the dynamic epigenetic changes specific to each athlete. This study will make it possible, for the first time, to evaluate whether an epigenetic signature predictive of the muscular response to an injury could also be found in blood cells.
- Conditions
- Muscle Injury
- Being tested
- Quadriceps microbiopsy and blood collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadriceps microbiopsy and blood collectionOther
Microbiopsy of the quadriceps muscle using a needle, "Tru-cut" biopsy, associated with a blood sampling at the start and after 6 months of a muscle strengthening training program
| Study group | Role | What they receive |
|---|---|---|
| Muscular response to the training | Experimental | Epigenetic signature associated with different levels of muscle response induced by 6-month training Receives: Other: Quadriceps microbiopsy and blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA methylation profile of satellite cells associated with a gain in muscle mass
DNA methylation profile of satellite cells from the quadriceps obtained from athletes at the start and after 6 months of training, will be determine using DNA methylation profiling microarray.
Two groups of athletes will be constituted according to the gain (in % compared to the initial value) in muscular strength of the quadriceps induced by the training and evaluated on a strength bench.
In order to identify a DNA methylation signature associated to the gain in muscle mass, DNA methylation profile will be compared between athletes considered to be good or bad responders to training.
Measured: 6 months
Secondary outcomes (3)
Number and size of myoblasts obtained per satellite cells from the quadriceps
Satellite cells derived from quadriceps biopsy in athletes at the start and after 6 months of training will be placed in a culture dish treated with type 1 collagen in a thin layer of matrigel. After culture, proliferation and differentiation of myoblast cells will be assessed by cell counting and immunofluorescence with antibodies directed against muscle markers.
Measured: 6 months
Comparison of number and size of myoblasts obtained in vitro and the muscular response to training in the same athlete
Size of myotubes regenerated in vitro from satellite cells taken from athletes after 6 months of training will be compared to the gain in muscle mass, strength and endurance of the quadriceps induced by training in the same athlete.
Measured: 6 months
Comparison of the DNA methylation profile of satellite cells from the quadriceps and blood mononuclear cells in the same athlete
DNA methylation profile of satellite cells from the quadriceps and blood mononuclear cells obtained from athletes at the start and after 6 months of training, will be determine using DNA methylation profiling microarray. DNA methylation profile obtained from satellite cells and mononuclear cells in a same athlete will be compared to identify a correlation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study startSep 2025 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Comparative study of two groups of subjects formed a posteriori from a cohort follow-up
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279196
- Sponsor's protocol ID
- 21_0102
- Acronym
- CareStress
- Status last verified
- Sep 2024
- First submitted
- 3 Mar 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Variables Associated With the Response to Intensive Training in Athletes (CareStress)
- ClinicalTrials.gov ID
- NCT05279196
- Acronym / sponsor ID
- CareStress / 21_0102
- Conditions
- Muscle Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 15 Mar 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.
There is in humans, at the muscular level, a great interindividual variability in response to the same mechanical stress. This phenotypic variability is multifactorial, influenced by environmental factors as well as multiple genetic variants. Thus, for the same level of muscle damage, two subjects with the same anthropometric characteristic, the same age, with the same medical history and the same level of physical activity, will present a variable level of muscle regeneration underpinned by the biological function of muscular stem cells and their microenvironment. Thus, faced with the same training, some athletes will develop iterative muscular lesions and more disabling repair deficits than others without knowing the reason of this greater susceptibility.
Indeed, the links between the genotype of the skeletal muscle fiber and its response to exercise, as well as the regulation of muscle mass are poorly understood. Yet, in young adults, up to 70% of the observed variability in muscle strength and size is hereditary. This heritability of muscle size and strength seems to be lower in older people, probably related to increased comorbidity. Numerous experiments with athletes subjected to the same resistance exercise training have identified good and bad hypertrophic skeletal muscle responders. However, genetic variants that contribute to skeletal muscle strength and mass are largely understudied while a growing body of evidence indicates that epigenetic effectors, which modulate gene expression, may contribute to human muscle response heterogeneity to the same mechanical stress. Thus, to date, no analysis of the role of the interaction between genetic and epigenetic factors involved in the muscle functional response to exercise exists. The main hypothesis is that the epigenetic status of muscle stem cells (satellite cells) is an important contributor in muscle mass response to exercise by modulating chromatin architecture.
Thus this study will identify the epigenetic modifications induced by training and their interaction with the genetic factors involved in the response of the biological function of the satellite cells to this training and on the other hand, to be able to link it to a blood signature.
Detailed description
The study will be carried out in close collaboration with the Director of the Expertise and Sports Performance Center (CREPS) of Montpellier. Compared to the athlete's usual seasonal training program, his participation in research will be limited to two visits to the Montpellier University Hospital where a quadriceps micro biopsy and a blood test will be carried out. During the first visit to the Montpellier University Hospital, a short clinical examination will also be carried out including an interrogation on his medical history, his consumption of drugs, alcohol, tobacco as well as the measurement of his weight and height and a simple cardiopulmonary auscultation. As part of the standard care for athletes, the training program carried out at CREPS Montpellier will be defined by weekly strength exercises to increase muscle mass. As part of this program and approximately one week before the two visits to the Montpellier University Hospital, an evaluation of the mass and the contractile function of the muscle will be carried out. The measurement of muscle mass will be carried out by Magnetic Resonance Imaging. The contractile function of the quadriceps muscle will be measured on a weight bench equipped with a dynamometer at the CREPS in Montpellier. Data from these assessments will be collected as part of the research.
This study will allow the synthesis of a muscular organoid, representative of an in vivo muscle, allowing the in vitro study of muscular lesions associated with the rupture of muscle fibres and the activation of satellite cells allowing the regeneration of damaged fibres. This in vitro muscle model will allow us to evaluate the inter-individual variability of the muscle response to the same mechanical stress and to study its link with the dynamic epigenetic changes specific to each athlete. This study will make it possible, for the first time, to evaluate whether an epigenetic signature predictive of the muscular response to an injury could also be found in blood cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Comparative study of two groups of subjects formed a posteriori from a cohort follow-up
| Arm | Type | Receives |
|---|---|---|
| Muscular response to the training | Experimental | Other: Quadriceps microbiopsy and blood collectionEpigenetic signature associated with different levels of muscle response induced by 6-month training |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Senior male athlete aged between 40 and 60 inclusive
- Athlete following a program over a season of muscle building at CREPS, the objective of which is to improve their performance in a middle-distance race.
Key exclusion criteria (6 listed)
- Subject having a contraindication to follow the complete muscle building program at CREPS with in particular a contraindication to the measurement of muscle mass by Magnetic Resonance Imaging
- Subject presenting all criteria which can by themselves alter the function of the respiratory muscles such as chronic obstructive pulmonary disease, heart failure, systemic infection, neuromuscular pathology, psychiatric pathology, metabolic disorder.
- Subjects with coagulopathy or thrombocytopenia.
- Use of anabolic drugs to increase muscle mass
- Subject suspected of doping
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 |
|---|---|---|
| Quadriceps microbiopsy and blood collectionMicrobiopsy of the quadriceps muscle using a needle, "Tru-cut" biopsy, associated with a blood sampling at the start and after 6 months of a muscle strengthening training program | Other | Muscular response to the training |
Primary outcome
DNA methylation profile of satellite cells associated with a gain in muscle mass
Time frame: 6 months
DNA methylation profile of satellite cells from the quadriceps obtained from athletes at the start and after 6 months of training, will be determine using DNA methylation profiling microarray. Two groups of athletes will be constituted according to the gain (in % compared to the initial value) in muscular strength of the quadriceps induced by the training and evaluated on a strength bench. In order to identify a DNA methylation signature associated to the gain in muscle mass, DNA methylation profile will be compared between athletes considered to be good or bad responders to training.
3 secondary outcomes
Number and size of myoblasts obtained per satellite cells from the quadriceps
Time frame: 6 months
Comparison of number and size of myoblasts obtained in vitro and the muscular response to training in the same athlete
Time frame: 6 months
Comparison of the DNA methylation profile of satellite cells from the quadriceps and blood mononuclear cells in the same athlete
Time frame: 6 months
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadriceps microbiopsy and blood collection in people with Muscle Injury, run by University Hospital, Montpellier 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 6 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: opening soon, as of the sponsor's last update on 19 Sep 2024. 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 Stephan MATECKI, MD-PhD (467335908 ext. 33, stephan.matecki@umontpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA methylation profile of satellite cells associated with a gain in muscle mass (time frame: 6 months). 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 19 Sep 2024.