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Muscles in Liver Diseases

Muscles in Liver Diseases

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04758793
Acronym
UNIVERSE
Enrollment
260
Registered
2021-02-17
Start date
2021-02-15
Completion date
2026-05-31
Last updated
2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Having a Scheduled Abdominal Surgery Procedure

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.

Interventions

OTHERblood samples

3 citrated tubes and 3 EDTA tubes

OTHERbiopsy of abdominal paroie

a muscle biopsy will be performed on the incision area

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
describe the muscle changes that occur during liver disease.1 month after the of inclusionAssessment of the histology of the muscle removed during abdominal surgery by measuring the diameter of muscle fibers

Secondary

MeasureTime frameDescription
Identify circulating mediators that could be responsible for sarcopenia: released by the liver and acting on the muscle.1 month after the of inclusionCirculating 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 inclusionCirculating concentration of mediators / cells suspected of being released by muscle and contributing to organ dysfunction in liver disease: * extracellular vesicles * myokines

Contacts

Primary Contactpierre Emmanuel Rautou
pierre.emmanuel.rautou@aphp.fr140875283
Backup ContactEnis Kostallari
enis.kostallari@gmail.com140875283

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026