Liver Stiffness Measurement in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal

Completed

• Conditions: Alcohol Withdrawal

• Registration Number: NCT02202148
• Lead Sponsor: Centre Hospitalier Esquirol

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-25
• Study First Submitted QC: 2014-07-25
• Study First Posted: 2014-07-28
• Study Start: 2015-07
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	6 months maximum

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Hospitalier Esquirol; 🇫🇷 Limoges, France