Liver Stiffness Measurement in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alcohol Withdrawal
- Sponsor
- Centre Hospitalier Esquirol
- Enrollment
- 195
- Locations
- 1
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Philippe Nubukpo
MD, PhD
Centre Hospitalier Esquirol
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- controlled attenuation parameter (CAP) at each follow-up(6 months)
- serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6.(6 months)
- liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6(6 months)
- Variations in liver stiffness(6 months)