Alcohol WithdrawalNCT02202148
Liver Stiffness Measurement in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal
An observational study of Alcohol Withdrawal, run by Centre Hospitalier Esquirol at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Withdrawal
- How many people
- 195 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: alcohol-dependent subjects hospitalized for alcohol withdrawal
Who may be able to join
- participation to the study "BDNF serum levels evolution during 6 months after alcohol withdrawal" (main study)
- criteria from the main study
Who cannot join
- criteria from the main study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Alcohol Withdrawal
- Keywords
- Fibroscan, alcohol dependence, alcohol withdrawal, controlled attenuation parameter, BDNF
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| alcohol withdrawal | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months maximum
Secondary outcomes (4)
serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6.
Measured: 6 months
liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6
Measured: 6 months
Variations in liver stiffness
Measured: 6 months
controlled attenuation parameter (CAP) at each follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol WithdrawalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Dupuytren
- Responsible party
- Principal investigator, Philippe Nubukpo, Centre Hospitalier Esquirol
- Investigators
- Philippe Nubukpo, MD, PhD, Principal investigator, Centre Hospitalier Esquirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202148
- Sponsor's protocol ID
- 2014-A00854-43
- Status last verified
- Jan 2017
- First submitted
- 25 Jul 2014
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Stiffness Measurement in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal
- ClinicalTrials.gov ID
- NCT02202148
- Acronym / sponsor ID
- 2014-A00854-43
- Conditions
- Alcohol Withdrawal
- Keywords
- Fibroscan, alcohol dependence, alcohol withdrawal, controlled attenuation parameter, BDNF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Collaborators
- Hôpital Dupuytren
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| alcohol withdrawal | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- alcohol-dependent subjects hospitalized for alcohol withdrawal
Key inclusion criteria (2 listed)
- participation to the study "BDNF serum levels evolution during 6 months after alcohol withdrawal" (main study)
- criteria from the main study
Key exclusion criteria (1 listed)
- criteria from the main study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6.
Time frame: 6 months
liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6
Time frame: 6 months
Variations in liver stiffness
Time frame: 6 months
controlled attenuation parameter (CAP) at each follow-up
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Nubukpo, MD, PhD principal investigator
Centre Hospitalier Esquirol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Withdrawal, run by Centre Hospitalier Esquirol at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.