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

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ClinicalTrials.gov Identifier: NCT02202148
Recruitment Status : Completed
First Posted : July 28, 2014
Last Update Posted : January 31, 2017
Sponsor:
Collaborator:
Hôpital Dupuytren
Information provided by (Responsible Party):
Philippe Nubukpo, 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.


Condition or disease
Alcohol Withdrawal

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Study Type : Observational
Actual Enrollment : 195 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Group/Cohort
alcohol withdrawal



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6. [ Time Frame: 6 months ]
  2. liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6 [ Time Frame: 6 months ]
  3. Variations in liver stiffness [ Time Frame: 6 months ]
  4. controlled attenuation parameter (CAP) at each follow-up [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
alcohol-dependent subjects hospitalized for alcohol withdrawal
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202148


Locations
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France
Centre Hospitalier Esquirol
Limoges, France, 87025
Sponsors and Collaborators
Centre Hospitalier Esquirol
Hôpital Dupuytren
Investigators
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Principal Investigator: Philippe Nubukpo, MD, PhD Centre Hospitalier Esquirol

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Responsible Party: Philippe Nubukpo, MD, PhD, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier: NCT02202148     History of Changes
Other Study ID Numbers: 2014-A00854-43
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by Philippe Nubukpo, Centre Hospitalier Esquirol:
Fibroscan
alcohol dependence
alcohol withdrawal
controlled attenuation parameter
BDNF

Additional relevant MeSH terms:
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Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs