Muscles in Liver Diseases (UNIVERSE)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: pierre Emmanuel Rautou
- Numéro de téléphone: 33 140875283
- E-mail: pierre.emmanuel.rautou@aphp.fr
Sauvegarde des contacts de l'étude
- Nom: Enis Kostallari
- Numéro de téléphone: 33 140875283
- E-mail: enis.kostallari@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: patients without liver disease,
taking blood samples and biopsy of muscular wall
|
3 citrated tubes and 3 EDTA tubes
a muscle biopsy will be performed on the incision area
|
|
Autre: patient with chronic liver disease without cirrhosis,
taking blood samples and biopsy of muscular wall
|
3 citrated tubes and 3 EDTA tubes
a muscle biopsy will be performed on the incision area
|
|
Autre: patients with compensated cirrhosis,
taking blood samples and biopsy of muscular wall
|
3 citrated tubes and 3 EDTA tubes
a muscle biopsy will be performed on the incision area
|
|
Autre: patient with severe cirrhosis
taking blood samples and biopsy of muscular wall
|
3 citrated tubes and 3 EDTA tubes
a muscle biopsy will be performed on the incision area
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
describe the muscle changes that occur during liver disease.
Délai: 1 month after the of inclusion
|
Assessment of the histology of the muscle removed during abdominal surgery by measuring the diameter of muscle fibers
|
1 month after the of inclusion
|
|
describe the muscle changes that occur during liver disease.
Délai: 1 month after the of inclusion
|
Assessment of the histology of the muscle removed during abdominal surgery, by evaluating the vascularity with measurements of CD31 count and αSMA count
|
1 month after the of inclusion
|
|
describe the muscle changes that occur during liver disease.
Délai: 1 month after the of inclusion
|
Assessment of the histology of the muscle removed during abdominal surgery by evaluating the muscle stem cells with measurements of Pax7, MyoD and Myogenin
|
1 month after the of inclusion
|
|
describe the muscle changes that occur during liver disease.
Délai: 1 month after the of inclusion
|
Assessment of the histology of the muscle removed during abdominal surgery by evaluating gene expression with transcriptomics
|
1 month after the of inclusion
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Identify circulating mediators that could be responsible for sarcopenia: released by the liver and acting on the muscle.
Délai: 1 month after the of inclusion
|
Circulating concentration of mediators / cells suspected of being responsible for sarcopenia:
|
1 month after the of inclusion
|
|
Identify circulating mediators that could be responsible for complications of liver disease: released by the muscle and acting on the different organs
Délai: 1 month after the of inclusion
|
Circulating concentration of mediators / cells suspected of being released by muscle and contributing to organ dysfunction in liver disease:
|
1 month after the of inclusion
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- APHP201215
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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