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Active, Not Recruiting

NCT Number: NCT02873663

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alcohol Abuse Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Digestive System Diseases Liver Disease Liver Diseases Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasma and head hair collection

Procedure

Plasma and head hair collection

Primary outcomes

  1. 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

    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 outcomes

  1. 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)

    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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2010
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2016
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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