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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02202148
Other study ID # 2014-A00854-43
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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