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Understanding Loss of Muscle Mass and Function (SAMANTHA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004039
Recruitment Status : Withdrawn (Application to a CPP)
First Posted : July 1, 2019
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
INSERM U1046 CNRS UMR 9214, Montpellier University
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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. 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.

Condition or disease
Sarcopenia

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sarcopenia Mechanism and Therapeutic
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Reversal of sarcopenia with chemicals compounds extracted from wild aromatic plants from south of France vs control (not treated cells) [ Time Frame: 5 years ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Sarcopenic and non-sarcopenic patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004039


Locations
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France
Uh Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
INSERM U1046 CNRS UMR 9214, Montpellier University
Investigators
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Principal Investigator: Jacques Mercier, Pr University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04004039    
Other Study ID Numbers: RECHMPL19_0272
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Satellite cells
Therapeutic
Aromatic plants
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms