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

Not Applicable

Active, not recruiting

• Conditions: Alcohol Abuse; Liver Disease
• Interventions: Procedure: Plasma and head hair collection

• Registration Number: NCT02873663
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-04-13
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
heavy drinkers	Plasma and head hair collection	Plasma and head hair collection
teetotalers	Plasma and head hair collection	Plasma and head hair collection

Primary Outcome Measures

Name	Time	Method
level of disialotransferrin in blood (expressed as percentage di-sialotransferrin) and ethyl glucuronide (expressed in pg/mg) in hair	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	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.

Secondary Outcome Measures

Name	Time	Method
influence of the stage of liver and renal impairment on serum CDT and hair EtG	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)	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.

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium