Liver Stiffness Measurement in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal
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|ClinicalTrials.gov Identifier: NCT02202148|
Recruitment Status : Completed
First Posted : July 28, 2014
Last Update Posted : January 31, 2017
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||195 participants|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
- 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) [ Time Frame: 6 months maximum ]
- serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6. [ Time Frame: 6 months ]
- liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6 [ Time Frame: 6 months ]
- Variations in liver stiffness [ Time Frame: 6 months ]
- controlled attenuation parameter (CAP) at each follow-up [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202148
|Centre Hospitalier Esquirol|
|Limoges, France, 87025|
|Principal Investigator:||Philippe Nubukpo, MD, PhD||Centre Hospitalier Esquirol|