Clinical trial NCT02822911: Benefit of Carbohydrate Deficient Transferrin to Detect Chronic Alcohol Abuse in the Elderly
Official title: Benefit of Carbohydrate Deficient Transferrin to Detect Chronic Alcohol Abuse in the Elderly. A French Multicentered Prospective Interventional Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Keywords: elderly
chronic alcoholism
Carbohydrate Deficient Transferrin
Biological Detection / Diagnosis
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 194
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Benefit of Carbohydrate Deficient Transferrin to detect chronic alcohol abuse in the elderly compared to usual clinical detection tools
timeFrame: Within 3 days after enrollment in the study
Secondary outcomes:
measure: Sensitivity and specificity of the disturbance of Gamma-glutamyltranspeptidase when presence of alcohol consumption, with at least 1 point in the AUDIT-C questionnaire
timeFrame: Within 3 days after enrollment in the study
measure: 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
timeFrame: Within 3 days after enrollment in the study
measure: Socio-economic characteristics of alcohol abusers : Socioprofessional category
timeFrame: Within 3 days after enrollment in the study
measure: Socio-economic characteristics of alcohol abusers : Education Category
timeFrame: Within 3 days after enrollment in the study
measure: Socio-economic characteristics of alcohol abusers : Way of life
timeFrame: Within 3 days after enrollment in the study
Other outcomes:
Locations:
city: Colmar
country: France
facility: Reseau d'Appui aux Generalistes (RAG)
city: Mulhouse
country: France
facility: GHRMSA
Study officials:
affiliation: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
name: Cecile Schnell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henni A, Bideau C, Routon X, Berrut G, Cholet J. [Prevalence and issues of screening for alcohol consumption among elderly inpatients admitted to acute geriatric inpatient unit]. Geriatr Psychol Neuropsychiatr Vieil. 2013 Mar;11(1):33-41. doi: 10.1684/pnv.2013.0397. French.
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citation: Hermansson U, Helander A, Huss A, Brandt L, Ronnberg S. The Alcohol Use Disorders Identification Test (AUDIT) and carbohydrate-deficient transferrin (CDT) in a routine workplace health examination. Alcohol Clin Exp Res. 2000 Feb;24(2):180-7.
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citation: Schwan R, Albuisson E, Malet L, Loiseaux MN, Reynaud M, Schellenberg F, Brousse G, Llorca PM. The use of biological laboratory markers in the diagnosis of alcohol misuse: an evidence-based approach. Drug Alcohol Depend. 2004 Jun 11;74(3):273-9. doi: 10.1016/j.drugalcdep.2004.01.002.
citation: Allen JP, Litten RZ, Anton RF, Cross GM. Carbohydrate-deficient transferrin as a measure of immoderate drinking: remaining issues. Alcohol Clin Exp Res. 1994 Aug;18(4):799-812. doi: 10.1111/j.1530-0277.1994.tb00043.x.
citation: Bortolotti F, De Paoli G, Tagliaro F. Carbohydrate-deficient transferrin (CDT) as a marker of alcohol abuse: a critical review of the literature 2001-2005. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Sep 1;841(1-2):96-109. doi: 10.1016/j.jchromb.2006.05.005. Epub 2006 May 24.
citation: Salaspuro M. Carbohydrate-deficient transferrin as compared to other markers of alcoholism: a systematic review. Alcohol. 1999 Nov;19(3):261-71. doi: 10.1016/s0741-8329(99)00044-0.
citation: WHO Expert Committee on Problems Related to Alcohol Consumption. WHO Expert Committee on Problems Related to Alcohol Consumption. Second report. World Health Organ Tech Rep Ser. 2007;(944):1-53, 55-7, back cover.