Back to resultsBiomarkers for the Detection of Heavy Alcohol Use in Patients With and Without Liver Disease
Primary Purpose
Alcohol Abuse, Liver Disease
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Plasma and head hair collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Alcohol Abuse
Eligibility Criteria
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
Sites / Locations
- UZ Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
heavy drinkers
teetotalers
Arm Description
Plasma and head hair collection
Plasma and head hair collection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02873663
First Posted
April 13, 2011
Last Updated
August 16, 2016
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT02873663
Brief Title
Biomarkers for the Detection of Heavy Alcohol Use in Patients With and Without Liver Disease
Official Title
Biomarkers for the Detection of Heavy Alcohol Use in Patients With and Without Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Liver Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
heavy drinkers
Arm Type
Experimental
Arm Description
Plasma and head hair collection
Arm Title
teetotalers
Arm Type
Experimental
Arm Description
Plasma and head hair collection
Intervention Type
Procedure
Intervention Name(s)
Plasma and head hair collection
Intervention Description
Plasma and head hair collection
Primary Outcome Measure Information:
Title
level of disialotransferrin in blood (expressed as percentage di-sialotransferrin) and ethyl glucuronide (expressed in pg/mg) in hair
Description
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.
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 Outcome Measure Information:
Title
influence of the stage of liver and renal impairment on serum CDT and hair EtG
Description
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.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jef Verbeek, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Biomarkers for the Detection of Heavy Alcohol Use in Patients With and Without Liver Disease
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