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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02873663
Enrollment
140
Registered
2016-08-19
Start date
2010-12-31
Completion date
2025-08-31
Last updated
2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abuse, Liver Disease

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.

Interventions

PROCEDUREPlasma and head hair collection

Plasma and head hair collection

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
level of disialotransferrin in blood (expressed as percentage di-sialotransferrin) and ethyl glucuronide (expressed in pg/mg) in hairsingle determination at inclusion (both on the same day, when patient is seen at the outpatient clinic or when admitted to the hospital) without follow-upBlood 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

MeasureTime frameDescription
influence of the stage of liver and renal impairment on serum CDT and hair EtGon 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026