MedPath

Muscles in Liver Diseases

Not Applicable
Not yet recruiting
Conditions
Patients Having a Scheduled Abdominal Surgery Procedure
Interventions
Other: blood samples
Other: biopsy of abdominal paroie
Registration Number
NCT04758793
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Brief Summary

Cirrhosis is the 11th leading cause of death in the world. The progression to cirrhosis occurs as a result of chronic hepatic injury, related to excessive alcohol consumption, non-alcoholic steatohepatitis, chronic viral infection. Cirrhosis is accompanied by symptoms that profoundly affect the quality of life of patients.

Sarcopenia, or decrease in muscle capacity through loss of muscle mass, is associated with liver disease. Patients with liver disease and sarcopenia have increased morbidity, and higher pre- and post-liver transplant mortality than patients without sarcopenia. The mechanism responsible for the development of sarcopenia in liver disease remains largely misunderstood, as do the mechanisms by which sarcopenia appears to promote complications of liver disease.

This study, carried out on a prospective cohort of patients with liver disease, aims at understanding the pathophysiological mechanisms involved in sarcopenia and its consequences.

Detailed Description

Cirrhosis is the 11th leading cause of death in the world. The progression to cirrhosis occurs as a result of chronic hepatic injury, related to excessive alcohol consumption, non-alcoholic steatohepatitis, and chronic viral infection. Cirrhosis is accompanied by symptoms that profoundly affect the quality of life of patients.

Sarcopenia, or decrease in muscle capacity through loss of muscle mass, is associated with liver disease. Patients with liver disease and sarcopenia have increased morbidity, and higher pre- and post-liver transplant mortality than patients without sarcopenia. The mechanism responsible for the development of sarcopenia in liver disease remains largely misunderstood, as do the mechanisms by which sarcopenia appears to promote complications of liver disease.

This study, carried out on a prospective cohort of patients with stable liver disease, aims at understanding the pathophysiological mechanisms involved in sarcopenia and its consequences.

After checking the inclusion criteria, all eligible patients treated at Beaujon Hospital (Clichy) will be invited to participate in the study. After inclusion, clinical and laboratory features (hepatic assessment) will be collected and the blood samples will be taken.

During the surgery, a muscle biopsy will be performed on the incision area. No follow-up is planned.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
260
Inclusion Criteria
  • Patients over the age of 18 having a scheduled abdominal surgery at Beaujon Hospital
  • Patient affiliated to a social security scheme
  • Informed patient having signed a consent to participate
Exclusion Criteria

Primary muscle disease (myopathy, dermatopolymyositis, vasculitis with muscle involvement)

  • Amyotrophic drugs: long-term corticosteroid therapy
  • Immunosuppressive treatments
  • Chronic inflammatory disease (example: Crohn's disease)
  • Disease known to cause sarcopenia such as -but not limited to- active extrahepatic neoplasia, polycystic hepatorenal disease
  • Gastrointestinal haemorrhage in the 15 days prior to inclusion
  • Acute alcoholic hepatitis in the month before inclusion
  • Infection during treatment
  • Pregnant or breastfeeding woman
  • Protected populations: people under guardianship or under guardianship
  • Patient not affiliated to a social security scheme
  • Patient under AME
  • Patient not having signed consent

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
patients with compensated cirrhosis,blood samplestaking blood samples and biopsy of muscular wall
patients with compensated cirrhosis,biopsy of abdominal paroietaking blood samples and biopsy of muscular wall
patient with severe cirrhosisblood samplestaking blood samples and biopsy of muscular wall
patients without liver disease,biopsy of abdominal paroietaking blood samples and biopsy of muscular wall
patient with severe cirrhosisbiopsy of abdominal paroietaking blood samples and biopsy of muscular wall
patient with chronic liver disease without cirrhosis,biopsy of abdominal paroietaking blood samples and biopsy of muscular wall
patients without liver disease,blood samplestaking blood samples and biopsy of muscular wall
patient with chronic liver disease without cirrhosis,blood samplestaking blood samples and biopsy of muscular wall
Primary Outcome Measures
NameTimeMethod
describe the muscle changes that occur during liver disease.1 month after the of inclusion

Assessment of the histology of the muscle removed during abdominal surgery by evaluating gene expression with transcriptomics

Secondary Outcome Measures
NameTimeMethod
Identify circulating mediators that could be responsible for sarcopenia: released by the liver and acting on the muscle.1 month after the of inclusion

Circulating concentration of mediators / cells suspected of being responsible for sarcopenia:

* extracellular vesicles released by the liver

* lymphocyte phenotype potentially modified by sinusoidal endothelial cells of the liver

* protein array

Identify circulating mediators that could be responsible for complications of liver disease: released by the muscle and acting on the different organs1 month after the of inclusion

Circulating concentration of mediators / cells suspected of being released by muscle and contributing to organ dysfunction in liver disease:

* extracellular vesicles

* myokines

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