SarcopeniaSAMANTHANCT04004039
Understanding Loss of Muscle Mass and Function
An observational study of Sarcopenia, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Sarcopenia is a loss of muscle mass and function that develops during aging. But sarcopenia is also observed in several other conditions: chronic diseases, cancers, viral infections, renal / respiratory insufficiency, immobility, obesity with low physical activity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2018to 1 Aug 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sarcopenic and non-sarcopenic patients
Who may be able to join
- Patients undergoing quadriceps muscle biopsy as part of the treatment.
- Patient having given their agreement of conservation within the framework of the care of the biological sample (biopsy and blood sample)
Who cannot join
- Subject refusing the detection of anti-HIV, anti-hepatitis C antibodies, HBS antigen
- Subject treated with anticoagulant, beta blocker, lipid-lowering agent (statin or fibrate), anti-inflammatory, ACE inhibitors, angiotensin 2 receptor antagonist or corticosteroids, including locally.
- Allergic subject to local anesthetics
- History or presence of psychoactive substance abuse
- History of recent abdominal surgery (less than 3 months)
- Subject deprived of liberty by judicial or administrative decision
- Major subject protected by law
- Inability to understand the nature and purpose of the study and / or communication difficulties with the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sarcopenia Mechanism and Therapeutic
Sarcopenia is a loss of muscle mass and function that develops during aging. But sarcopenia is also observed in several other conditions: chronic diseases, cancers, viral infections, renal / respiratory insufficiency, immobility, obesity with low physical activity. This sarcopenia is named secondary sarcopenia to distinguish it from the age-associated primary sarcopenia. During prolonged hospitalizations in intensive care, a significant loss of muscular mass and function is also observed. This acute sarcopenia or Intensive Care Unit-Acquired Weakness (ICU-AW) may persist for several months after discharge from hospital. In addition to the loss of autonomy, the reduction of muscle mass has important metabolic implications, ranging from insulin resistance to modification of myokines production. Sarcopenia greatly increases the morbidity and mortality of patients regardless of its cause. The aim of our project is to identify the molecular mechanisms implicated in sarcopenia from different origin. We will particularly focus our work on the metabolic properties, the proliferation/ differentiation and regeneration capacities of the satellite cells (adult muscle stem cells). These satellite cells will be purified from quadriceps biopsies of human volunteers recruited at CHU Montpellier. These satellite cells will also be used to test the ability of some wild aromatic plants from south of France to improve cell survival and differentiation. This will allow us to identify the molecular mechanisms involved in sarcopenia development and identify potential therapeutic molecules.
- Conditions
- Sarcopenia
- Keywords
- Satellite cells, Therapeutic, Aromatic plants
- Medical subject headings
- Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Properties and characterization of satellite cells of healthy subjects compared to satellite cells of subjects with sarcopenia.
Properties and characterization of satellite cells of healthy subjects compared to satellite cells of subjects with sarcopenia, 9 outcomes : Diameter of myotubes in culture, Immune properties, Proliferation: cell growth curve, Differentiation: expression of some proteins specific of myotubes as myogenin and troponin T by Western Blotting, Differentiation: expression of troponin T by microscopy and immunofluorescence, Differentiation: expression of some mRNA coding for specific protein by RTqPCR, Transcriptomic analysis, Mitochondria activity: citrate synthase activity, Mitochondria quantity by Western Blot analysis
Measured: 6 years
Secondary outcomes (1)
Reversal of sarcopenia with chemicals compounds extracted from wild aromatic plants from south of France vs control (not treated cells)
Reversal of sarcopenia with chemicals compounds extracted from wild aromatic plants from south of France vs control, 7 outcomes : Diameter of myotubes in culture, Improvement of cell survival (Viability by FACS in % of cells/ml of cell culture media compared to control), Differentiation: expression of some proteins specific of myotubes as myogenin and troponin T by Western Blotting, Differentiation: expression of troponin T by microscopy and immunofluorescence, Differentiation: expression of some mRNA coding for specific protein by RTqPCR, Mitochondria activity: citrate synthase activity, Mitochondria quantity by Western Blot analysis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Oct 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Why it stopped: Application to a CPP
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U1046 CNRS UMR 9214, Montpellier University
- Responsible party
- Sponsor
- Investigators
- Jacques Mercier, Pr, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004039
- Sponsor's protocol ID
- RECHMPL19_0272
- Acronym
- SAMANTHA
- Status last verified
- Aug 2019
- First submitted
- 7 Jun 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia Mechanism and Therapeutic
- ClinicalTrials.gov ID
- NCT04004039
- Acronym / sponsor ID
- SAMANTHA / RECHMPL19_0272
- Conditions
- Sarcopenia
- Keywords
- Satellite cells, Therapeutic, Aromatic plants
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Application to a CPP
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- INSERM U1046 CNRS UMR 9214, Montpellier University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 1 Jul 2019 (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.
Sarcopenia is a loss of muscle mass and function that develops during aging. But sarcopenia is also observed in several other conditions: chronic diseases, cancers, viral infections, renal / respiratory insufficiency, immobility, obesity with low physical activity. This sarcopenia is named secondary sarcopenia to distinguish it from the age-associated primary sarcopenia. During prolonged hospitalizations in intensive care, a significant loss of muscular mass and function is also observed. This acute sarcopenia or Intensive Care Unit-Acquired Weakness (ICU-AW) may persist for several months after discharge from hospital. In addition to the loss of autonomy, the reduction of muscle mass has important metabolic implications, ranging from insulin resistance to modification of myokines production. Sarcopenia greatly increases the morbidity and mortality of patients regardless of its cause. The aim of our project is to identify the molecular mechanisms implicated in sarcopenia from different origin. We will particularly focus our work on the metabolic properties, the proliferation/ differentiation and regeneration capacities of the satellite cells (adult muscle stem cells). These satellite cells will be purified from quadriceps biopsies of human volunteers recruited at CHU Montpellier. These satellite cells will also be used to test the ability of some wild aromatic plants from south of France to improve cell survival and differentiation. This will allow us to identify the molecular mechanisms involved in sarcopenia development and identify potential therapeutic molecules.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sarcopenic and non-sarcopenic patients
Key inclusion criteria (2 listed)
- Patients undergoing quadriceps muscle biopsy as part of the treatment.
- Patient having given their agreement of conservation within the framework of the care of the biological sample (biopsy and blood sample)
Key exclusion criteria (8 listed)
- Subject refusing the detection of anti-HIV, anti-hepatitis C antibodies, HBS antigen
- Subject treated with anticoagulant, beta blocker, lipid-lowering agent (statin or fibrate), anti-inflammatory, ACE inhibitors, angiotensin 2 receptor antagonist or corticosteroids, including locally.
- Allergic subject to local anesthetics
- History or presence of psychoactive substance abuse
- History of recent abdominal surgery (less than 3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Properties and characterization of satellite cells of healthy subjects compared to satellite cells of subjects with sarcopenia.
Time frame: 6 years
Properties and characterization of satellite cells of healthy subjects compared to satellite cells of subjects with sarcopenia, 9 outcomes : Diameter of myotubes in culture, Immune properties, Proliferation: cell growth curve, Differentiation: expression of some proteins specific of myotubes as myogenin and troponin T by Western Blotting, Differentiation: expression of troponin T by microscopy and immunofluorescence, Differentiation: expression of some mRNA coding for specific protein by RTqPCR, Transcriptomic analysis, Mitochondria activity: citrate synthase activity, Mitochondria quantity by Western Blot analysis
1 secondary outcome
Reversal of sarcopenia with chemicals compounds extracted from wild aromatic plants from south of France vs control (not treated cells)
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: Undecided. NC
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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.
Jacques Mercier, Pr principal investigator
University Hospital, Montpellier
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 Sarcopenia, 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 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: withdrawn, as of the sponsor's last update on 12 Aug 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Properties and characterization of satellite cells of healthy subjects compared to satellite cells of subjects with sarcopenia. (time frame: 6 years). 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 12 Aug 2019.