- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04004039
Understanding Loss of Muscle Mass and Function (SAMANTHA)
August 8, 2019 updated by: University Hospital, Montpellier
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.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Montpellier, France, 34295
- UH Montpellier
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Sarcopenic and non-sarcopenic patients
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Properties and characterization of satellite cells of healthy subjects compared to satellite cells of subjects with sarcopenia.
Time Frame: 6 years
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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
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6 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reversal of sarcopenia with chemicals compounds extracted from wild aromatic plants from south of France vs control (not treated cells)
Time Frame: 5 years
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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
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jacques Mercier, Pr, University Hospital, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
August 1, 2019
Study Registration Dates
First Submitted
June 7, 2019
First Submitted That Met QC Criteria
June 28, 2019
First Posted (Actual)
July 1, 2019
Study Record Updates
Last Update Posted (Actual)
August 12, 2019
Last Update Submitted That Met QC Criteria
August 8, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL19_0272
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
NC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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