Biomarkers for the Detection of Heavy Alcohol Use in Patients With and Without Liver Disease

Study Overview
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Brief Summary
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The investigators will test the validity of biomarkers for the detection of heavy alcohol use in patients with and without liver disease.

Detailed Description
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The investigators will test the validity of biomarkers for the detection of heavy alcohol use in patients with and without liver disease. The investigators will test the validity of carbohydrate deficient transferrin (CDT)(using capillary zone electrophoresis) in blood and ethyl glucuronide (EtG)(using Liquid Chromatography-MS-MS) in hair in patients with heavy alcohol use, moderate alcohol use and patients who do not drink alcohol.

Official Title
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Biomarkers for the Detection of Heavy Alcohol Use in Patients With and Without Liver Disease

Conditions
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Alcohol Abuse, Liver Disease

Intervention / Treatment
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* Procedure: Plasma and head hair collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who do not drink alcohol, moderate drinkers (between 0 and 60 g a day) and patients who drink 60 or more grams alcohol a day Exclusion criteria refusal for inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: heavy drinkers<br>Plasma and head hair collection | Procedure: Plasma and head hair collection<br>* Plasma and head hair collection<br>|
| Experimental: teetotalers<br>Plasma and head hair collection | Procedure: Plasma and head hair collection<br>* Plasma and head hair collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of disialotransferrin in blood (expressed as percentage di-sialotransferrin) and ethyl glucuronide (expressed in pg/mg) in hair | Blood and hair will be collected at one single time-point (procedure of blood and hair sampling takes 30 min) to measure serum CDT and hair ethylglucuronide levels (markers of alcohol use in the prior time period) when the patient presents itself at the hospital, without further follow-up. | single determination at inclusion (both on the same day, when patient is seen at the outpatient clinic or when admitted to the hospital) without follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influence of the stage of liver and renal impairment on serum CDT and hair EtG | Blood and hair will be collected at one single time-point (procedure of blood and hair sampling takes 30 min) to measure serum CDT and hair ethylglucuronide levels (markers of alcohol use in the prior time period) when the patient presents itself at the hospital, without further follow-up. Liver and kidney parameters are analyzed in the blood in the context of standard care. | on the basis of a single determination which is done for the standard care (when patient is seen at the outpatient clinic or when admitted to the hospital) |