Overview

This trial is active, not recruiting.

Conditions alcohol abuse, liver disease
Treatment plasma and head hair collection
Sponsor Universitaire Ziekenhuizen Leuven
Start date December 2010
End date August 2016
Trial size 140 participants
Trial identifier NCT02873663, S53031

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification bio-availability study
Intervention model factorial assignment
Masking single blind (investigator)
Primary purpose diagnostic
Arm
(Experimental)
Plasma and head hair collection
plasma and head hair collection
Plasma and head hair collection
(Experimental)
Plasma and head hair collection
plasma and head hair collection
Plasma and head hair collection

Primary Outcomes

Measure
level of disialotransferrin in blood (expressed as percentage di-sialotransferrin) and ethyl glucuronide (expressed in pg/mg) in hair
time frame: 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 Outcomes

Measure
influence of the stage of liver and renal impairment on serum CDT and hair EtG
time frame: 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)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Biomarkers for the Detection of Heavy Alcohol Use in Patients With and Without Liver Disease
Principal investigator Jef Verbeek, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.