NCT04004039

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

June 7, 2019

Last Update Submit

August 8, 2019

Conditions

Keywords

Satellite cellsTherapeuticAromatic plants

Outcome Measures

Primary Outcomes (1)

  • 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

    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)

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sarcopenic and non-sarcopenic patients

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Jacques Mercier, Pr

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2019

First Posted

July 1, 2019

Study Start

October 1, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 12, 2019

Record last verified: 2019-08

Locations