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

Alcohol Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02873663
• Other study ID #: S53031
• Status: Active, not recruiting
• Phase: N/A
• First received: April 13, 2011
• Last updated: August 16, 2016
• Start date: December 2010
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Liver Disease
• Liver Diseases

Intervention

Procedure:
• Plasma and head hair collection
Plasma and head hair collection

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No