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.
研究概览
地位
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：pierre Emmanuel Rautou
- 电话号码：33 140875283
- 邮箱：pierre.emmanuel.rautou@aphp.fr
研究联系人备份
- 姓名：Enis Kostallari
- 电话号码：33 140875283
- 邮箱：enis.kostallari@gmail.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：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
|
|
其他：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
|
|
其他：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
|
|
其他：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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
describe the muscle changes that occur during liver disease.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Identify circulating mediators that could be responsible for sarcopenia: released by the liver and acting on the muscle.
大体时间：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
大体时间：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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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blood samples的临床试验
-
Centre Hospitalier Universitaire de Saint Etienne完全的