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

Alcohol Withdrawal Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202148
• Other study ID #: 2014-A00854-43
• Status: Completed
• Phase: N/A
• First received: July 25, 2014
• Last updated: January 30, 2017
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Esquirol
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Withdrawal

Locations

Country	Name	City	State
France	Centre Hospitalier Esquirol	Limoges

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Esquirol	Hôpital Dupuytren

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6.		6 months
Secondary	liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6		6 months
Secondary	Variations in liver stiffness		6 months
Secondary	controlled attenuation parameter (CAP) at each follow-up		6 months