Clinical trial NCT04758793: Muscles in Liver Diseases
Official title: Muscles in Liver Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patients Having a Scheduled Abdominal Surgery Procedure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: describe the muscle changes that occur during liver disease.
timeFrame: 1 month after the of inclusion
measure: describe the muscle changes that occur during liver disease.
timeFrame: 1 month after the of inclusion
measure: describe the muscle changes that occur during liver disease.
timeFrame: 1 month after the of inclusion
measure: describe the muscle changes that occur during liver disease.
timeFrame: 1 month after the of inclusion
Secondary outcomes:
measure: Identify circulating mediators that could be responsible for sarcopenia: released by the liver and acting on the muscle.
timeFrame: 1 month after the of inclusion
measure: Identify circulating mediators that could be responsible for complications of liver disease: released by the muscle and acting on the different organs
timeFrame: 1 month after the of inclusion
Other outcomes:
Locations:
Study officials:
References: