Benefit of Carbohydrate Deficient Transferrin to Detect Chronic Alcohol Abuse in the Elderly

NCT02822911 | Completed

• 2 other identifiers: GHRMSA 8092016-A00027-44
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 2

Brief Summary

Alcohol misuse affects 5 million people in France. Even though the elderly are also concerned by this pathology, there is not much information about chronic alcohol misuse of this population in particular. Biological markers like gamma-glutamyltranspeptidase (GGT), mean corpuscular volume (MCV) and carbohydrate deficient transferrin (CDT) are usually used to detect alcohol abuse. As a biological marker of alcohol misuse, the specificity of the CDT is known to be superior to the GGT as well. However, when it comes to the elderly, alcoholism diagnosis tools are based on research of younger populations. This study aims to evaluate the benefit of the CDT to detect chronic alcohol use in the elderly.

Conditions

Alcohol Abuse

Keywords

elderly; chronic alcoholism; Carbohydrate Deficient Transferrin; Biological Detection / Diagnosis

Outcome Measures

Primary Outcomes (1)

• Benefit of Carbohydrate Deficient Transferrin to detect chronic alcohol abuse in the elderly compared to usual clinical detection tools

  Analysis performed when at least 1 point at the AUDIT-C questionnaire, confirming presence of alcohol consumption

  Within 3 days after enrollment in the study

Secondary Outcomes (5)

• Sensitivity and specificity of the disturbance of Gamma-glutamyltranspeptidase when presence of alcohol consumption, with at least 1 point in the AUDIT-C questionnaire

  Within 3 days after enrollment in the study

• Sensitivity and specificity of the disturbance of Mean Corpuscular Volume when presence of alcohol consumption, with at least 1 point in the AUDIT-C questionnaire

  Within 3 days after enrollment in the study

• Socio-economic characteristics of alcohol abusers : Socioprofessional category

  Within 3 days after enrollment in the study

• Socio-economic characteristics of alcohol abusers : Education Category

  Within 3 days after enrollment in the study

• Socio-economic characteristics of alcohol abusers : Way of life

  Within 3 days after enrollment in the study

Study Arms (1)

Alcohol Used Disorders Identification Test (AUDIT C)

OTHER

Submission of Audit-C questionnaire to all the patients of the study. When the result to the AUDIT-C questionnaire reaches at least 1 point, the analysis of the Carbohydrate deficient transferrin (CDT) is performed within 3 days after the beginning of the study. Results of Gamma glutamyl transpeptidase (GGT) and Mean Corpuscular Volume (MCV) performed as routine practice collected at the same time as the CDT analysis.

Behavioral: Alcohol Used Disorders Identification Test (AUDIT C); Procedure: Carbohydrate deficient transferrin; Procedure: Gamma glutamyl transpeptidase; Procedure: Mean Corpuscular Volume

Interventions

Alcohol Used Disorders Identification Test (AUDIT C) BEHAVIORAL

The Audit-C questionnaire is a three item alcohol screen that can help identify persons who are hazardous drinkers or have active alcohol abuse disorders (including alcohol abuse or dependence). The AUDIT-C is a modified version of the 10 question AUDIT instrument. Score from 0 to 12. Each Audit-C question has a 5 answer choice, allotted points are from 0 to 4 points. In men, a score of 4 is considered as positive, optimal for identifying hazardous users or active alcohol abuse disorders. The same for 3 points in women.

Also known as: Audit-C questionnaire

Alcohol Used Disorders Identification Test (AUDIT C)

Carbohydrate deficient transferrin PROCEDURE

Blood sample to collect carbohydrate deficient transferrin (CDT) only if the Alcohol Used Disorders Identification Test (AUDIT C) reports at least 1 point.

Also known as: CDT

Alcohol Used Disorders Identification Test (AUDIT C)

Gamma glutamyl transpeptidase PROCEDURE

Results of Gamma glutamyl transpeptidase (GGT) performed as routine practice collected only if the Alcohol Used Disorders Identification Test (AUDIT C) reaches at least 1 point.

Also known as: GGT

Alcohol Used Disorders Identification Test (AUDIT C)

Mean Corpuscular Volume PROCEDURE

Results of Mean Corpuscular Volume (MCV) performed as routine practice collected only if the Alcohol Used Disorders Identification Test (AUDIT C) reports at least 1 point.

Also known as: MCV

Alcohol Used Disorders Identification Test (AUDIT C)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 60 years old
• Patients hospitalized for a day or more in the Geriatrics Department of Mulhouse, GHRMSA :
• Coming from home within 48 hours after admission to the GHRMSA
• Study procedures performed within 72 hours after admission to the GHRMSA
• Or new members of the General Practitioner Support Association of Alsace, France (translated in French as the "RAG") living in Mulhouse, Thann and Saint Louis cities (France) :
• Living at home and joining the RAG between the 1st of March and the 31st of October 2016
• Study Procedures performed within 3 days after enrollment in the study
• Relative or helper available who usually visits the patient at home at least once a week
• Absence of alcoholic excipient in the concomitant medication

You may not qualify if:

• Age \< 60 years old
• Admitted in the Geriatrics Department of Mulhouse after more than 48hours after admission to the GHRMSA
• Presence of the following symptoms :
• Hepatobiliary deficiency related to a primary biliary cirrhosis
• Autoimmune or viral cirrhosis
• Hepatocellular carcinoma
• Congenital metabolic disorder in protein glycosylation
• Known genetics variance in Tf B or D transferrin
• Living in an elderly care institution
• Already enrolled in this study

Sponsors & Collaborators

• Groupe Hospitalier de la Region de Mulhouse et Sud Alsace: lead

Study Sites (2)

Reseau d'Appui aux Generalistes (RAG)

Colmar, 68000, France

Location

GHRMSA

Mulhouse, 68100, France

Location

Related Publications (1)

• Schnell C (2016) Benefit of carbohydrate deficient transferrin in detecting chronic alcohol abuse in the elderly: study protocol for a multicentre, non-randomized, open-label study. Clin Transl Degener Dis 1(3):121-126.

  BACKGROUND

Related Links

• Study Protocol

MeSH Terms

Conditions

Alcoholism; Disease

Interventions

Ethanol; carbohydrate-deficient transferrin; gamma-Glutamyltransferase; Erythrocyte Indices

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Aminoacyltransferases; Acyltransferases; Transferases; Enzymes; Enzymes and Coenzymes; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Cecile Schnell, MD

  Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 6, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 20, 2025

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)