Liver Stiffness Measurement in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal
This study is complementary to the main study "Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal " NCT01491347.
Liver stiffness variation is one of the major somatic effect of chronic alcohol consumption. It is a consequence of numerous mechanisms, including inflammation. Liver stiffness seems to depend on alcohol consumption in alcohol dependent patient, more precisely on the time after the last alcohol consumption. This is very few documented after alcohol withdrawal, and has never been explored during several months after withdrawal as a function of alcohol consumption and abstinence.
Brain Derived neurotrophic Factor (BDNF) seems to play a major role in general homeostasis and also liver function.
We propose here to analyse the serum BDNF levels variations after withdrawal according to liver stiffness levels and alcohol consumption status.
We will also measure liver stiffness using Fibroscan® in alcohol dependent subjects included in the main study to search for a link with serum BDNF levels and abstinence at day 0, 14, 28 and months 2, 4, and 6.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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Limoges、法国、87025
- Centre Hospitalier Esquirol
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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
取样方法
研究人群
描述
Inclusion Criteria:
- participation to the study "BDNF serum levels evolution during 6 months after alcohol withdrawal" (main study)
- criteria from the main study
Exclusion Criteria:
- criteria from the main study
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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戒酒
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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BDNF serum levels as a function of stiffness categories in the abstinent and non abstinent groups at inclusion and at the different follow-ups of the study (M2, M4, M6)
大体时间:6 months maximum
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6 months maximum
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次要结果测量
结果测量 |
大体时间 |
---|---|
serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6.
大体时间:6 months
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6 months
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liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6
大体时间:6 months
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6 months
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Variations in liver stiffness
大体时间:6 months
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6 months
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controlled attenuation parameter (CAP) at each follow-up
大体时间:6 months
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6 months
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合作者和调查者
调查人员
- 首席研究员:Philippe Nubukpo, MD, PhD、Centre Hospitalier Esquirol
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
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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