- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02202148
Liver Stiffness Measurement in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Limoges, France, 87025
- Centre Hospitalier Esquirol
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
alcohol withdrawal
|
What is the study measuring?
Primary Outcome Measures
Outcome 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)
Time Frame: 6 months maximum
|
6 months maximum
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6.
Time Frame: 6 months
|
6 months
|
liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6
Time Frame: 6 months
|
6 months
|
Variations in liver stiffness
Time Frame: 6 months
|
6 months
|
controlled attenuation parameter (CAP) at each follow-up
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philippe Nubukpo, MD, PhD, Centre Hospitalier Esquirol
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2014-A00854-43
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Withdrawal
-
VA Salt Lake City Health Care SystemCompleted
-
Denver Health and Hospital AuthorityTerminatedAlcohol Withdrawal Delirium | Alcohol Withdrawal Associated Autonomic Hyperactivity | Alcohol Withdrawal Hallucinosis | Alcohol Withdrawal-Induced Delirium TremensUnited States
-
University of Colorado, DenverWithdrawnAlcohol WithdrawalUnited States
-
Stanford UniversityCompletedAlcohol WithdrawalUnited States
-
Unity Health TorontoTerminatedAlcohol Withdrawal | Alcohol Withdrawal Delirium | Alcohol Withdrawal SeizuresCanada
-
Medical University of ViennaCompletedPsychophysiologic Reaction | Alcohol WithdrawalAustria
-
University Hospital, MontpellierCompletedAddiction | Alcohol Use Disorder | Alcohol Withdrawal SyndromeFrance
-
Jonathan RosensonAlameda County Medical CenterCompleted
-
Jubilee Mission Medical College and Research InstituteINCRE fellowship from DBT, govt of IndiaCompletedAlcohol Withdrawal Symptoms | Delirium Tremens (DTs)
-
Yale UniversityRecruiting