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

Not Applicable

Completed

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

• Registration Number: NCT02822911
• Lead Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-06
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alcohol Used Disorders Identification Test (AUDIT C)	Mean Corpuscular Volume	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.
Alcohol Used Disorders Identification Test (AUDIT C)	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.
Alcohol Used Disorders Identification Test (AUDIT C)	Gamma glutamyl transpeptidase	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.
Alcohol Used Disorders Identification Test (AUDIT C)	Carbohydrate deficient transferrin	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.

Primary Outcome Measures

Name	Time	Method
Benefit of Carbohydrate Deficient Transferrin to detect chronic alcohol abuse in the elderly compared to usual clinical detection tools	Within 3 days after enrollment in the study	Analysis performed when at least 1 point at the AUDIT-C questionnaire, confirming presence of alcohol consumption

Secondary Outcome Measures

Name	Time	Method
Socio-economic characteristics of alcohol abusers : Socioprofessional category	Within 3 days after enrollment in the study	Classification of professions and socioprofessional categories of the French National institute of Statistics and economics. 9 types of working classes.
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	If collected as routine practice : at the same time as Carbohydrate Deficient Transferrin analysis when Audit-C questionnaire reports at least 1 point
Socio-economic characteristics of alcohol abusers : Way of life	Within 3 days after enrollment in the study	Description of the patient's environment : * married or not; * living alone or not; * professional help provided at home by either a nurse, or cleaning lady, or meal delivery, or senior helper
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	If collected as routine practice : at the same time as Carbohydrate Deficient Transferrin analysis when Audit-C questionnaire reports at least 1 point
Socio-economic characteristics of alcohol abusers : Education Category	Within 3 days after enrollment in the study	6 levels of education type, from no degree or 9th grade, to Doctor of Philosophy (PhD). Classification created by the French National institute of Statistics and economics

Trial Locations

Locations (2)

Reseau d'Appui aux Generalistes (RAG); 🇫🇷 Colmar, France

GHRMSA; 🇫🇷 Mulhouse, France