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

NCT ID: NCT02822911

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-10-31

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.

Detailed Description

Problematic alcohol misuse is frequent but tends to decrease with age. According to the French Alcohology Society, 10% of the adult population is alcohol abstinent and after 65 years old, they are 40% to abstain from alcohol.

On the other hand, the French Alcohology Society also reports that a regular or daily alcohol consumption for older people increases the risk of dependence on alcohol.

For the elderly, biological disorders can be related to polymedication or other conditions related to the aging process, making it difficult to diagnose alcoholism for aged people.

For the study, the three-item Alcohol Use Disorders Identification Test (AUDIT-C) will be submitted to :

• every patient admitted in the Hospital of Mulhouse (France) for at least a day in the Geriatrics Department
• every patient entering the General Practitioner Support Association of Alsace, France (translated in French as the "RAG").

When the score of the AUDIT-C reaches at least 1 point, the study will collect results of the GGT and MCV performed as routine practice and add the CDT in the blood tests.

Conditions

Alcohol Abuse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Alcohol Used Disorders Identification Test (AUDIT C)

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.

Group Type: OTHER

Alcohol Used Disorders Identification Test (AUDIT C)

Intervention Type: 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.

Carbohydrate deficient transferrin

Intervention Type: PROCEDURE

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

Gamma glutamyl transpeptidase

Intervention Type: 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.

Mean Corpuscular Volume

Intervention Type: 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.

Interventions

Alcohol Used Disorders Identification Test (AUDIT C)

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.

Intervention Type: BEHAVIORAL

Carbohydrate deficient transferrin

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

Intervention Type: PROCEDURE

Gamma glutamyl transpeptidase

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.

Intervention Type: PROCEDURE

Mean Corpuscular Volume

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.

Intervention Type: PROCEDURE

Other Intervention Names

Audit-C questionnaire; CDT; GGT; MCV

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecile Schnell, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Locations

Reseau d'Appui aux Generalistes (RAG)

Colmar, , France

GHRMSA

Mulhouse, , France

Countries

France

References

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.

Reference Type: BACKGROUND

Related Links

https://www.researchgate.net/publication/308755873_Benefit_of_carbohydrate_deficient_transferrin_in_detecting_chronic_alcohol_abuse_in_the_elderly_study_protocol_for_a_multicentre_non-randomized_open-label_study

Study Protocol

Other Identifiers

2016-A00027-44

Identifier Type: OTHER

Identifier Source: secondary_id

GHRMSA 809

Identifier Type: -

Identifier Source: org_study_id