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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02202148

Enrollment

195

Registered

2014-07-28

Start date

2015-07-31

Completion date

2016-12-31

Last updated

2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Withdrawal

Keywords

Fibroscan, alcohol dependence, alcohol withdrawal, controlled attenuation parameter, BDNF

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
controlled attenuation parameter (CAP) at each follow-up	6 months

Countries

France

Outcome results