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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: pierre Emmanuel Rautou
- Telefonní číslo: 33 140875283
- E-mail: pierre.emmanuel.rautou@aphp.fr
Studijní záloha kontaktů
- Jméno: Enis Kostallari
- Telefonní číslo: 33 140875283
- E-mail: enis.kostallari@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: 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
|
|
Jiný: 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
|
|
Jiný: 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
|
|
Jiný: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
describe the muscle changes that occur during liver disease.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Identify circulating mediators that could be responsible for sarcopenia: released by the liver and acting on the muscle.
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- APHP201215
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