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临床试验/NCT04758793
NCT04758793尚未招募不适用

Muscles in Liver Diseases

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 260 人开始时间: 2021年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
260
主要终点
describe the muscle changes that occur during liver disease.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

describe the muscle changes that occur during liver disease.

时间窗: 1 month after the of inclusion

Assessment of the histology of the muscle removed during abdominal surgery by measuring the diameter of muscle fibers

次要结局

  • Identify circulating mediators that could be responsible for sarcopenia: released by the liver and acting on the muscle.(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(1 month after the of inclusion)

研究者

申办方类型
Other
责任方
Sponsor

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