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Completed

NCT Number: NCT02822911

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

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Audit-C questionnaire

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.

Other names: CDT

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.

Other names: GGT

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.

Other names: MCV

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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

  2. 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

    Time frame: 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

  3. Socio-economic characteristics of alcohol abusers : Socioprofessional category

    Time frame: 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.

  4. Socio-economic characteristics of alcohol abusers : Education Category

    Time frame: 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

  5. Socio-economic characteristics of alcohol abusers : Way of life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Other

Registry information

Official study title

Benefit of Carbohydrate Deficient Transferrin to Detect Chronic Alcohol Abuse in the Elderly. A French Multicentered Prospective Interventional Study.

Acronym: Caesar

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 6, 2016
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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