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

Alcohol Abuse Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822911
• Other study ID #: 809
• Secondary ID: 2016-A00027-44
• Status: Completed
• Phase: N/A
• First received: June 30, 2016
• Last updated: November 23, 2016
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism

Intervention

Behavioral:
• 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.

Procedure:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Reseau d'Appui aux Generalistes (RAG)	Colmar
France	GHRMSA	Mulhouse

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

References & Publications (9)

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. Review. — View Citation

Anton RF, Lieber C, Tabakoff B; CDTect Study Group.. Carbohydrate-deficient transferrin and gamma-glutamyltransferase for the detection and monitoring of alcohol use: results from a multisite study. Alcohol Clin Exp Res. 2002 Aug;26(8):1215-22. — View 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. Review. — View 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. — View Citation

Hermansson U, Helander A, Huss A, Brandt L, Rönnberg 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. — View Citation

Mundle G, Ackermann K, Munkes J, Steinle D, Mann K. Influence of age, alcohol consumption and abstinence on the sensitivity of carbohydrate-deficient transferrin, gamma-glutamyltransferase and mean corpuscular volume. Alcohol Alcohol. 1999 Sep-Oct;34(5):760-6. — View Citation

Salaspuro M. Carbohydrate-deficient transferrin as compared to other markers of alcoholism: a systematic review. Alcohol. 1999 Nov;19(3):261-71. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Sensitivity and specificity of the disturbance of Gamma-glutamyltranspeptidase when presence of alcohol consumption, with at least 1 point in the AUDIT-C questionnaire	If collected as routine practice : at the same time as Carbohydrate Deficient Transferrin analysis when Audit-C questionnaire reports at least 1 point	Within 3 days after enrollment in the study	No
Secondary	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	If collected as routine practice : at the same time as Carbohydrate Deficient Transferrin analysis when Audit-C questionnaire reports at least 1 point	Within 3 days after enrollment in the study	No
Secondary	Socio-economic characteristics of alcohol abusers : Socioprofessional category	Classification of professions and socioprofessional categories of the French National institute of Statistics and economics. 9 types of working classes.	Within 3 days after enrollment in the study	No
Secondary	Socio-economic characteristics of alcohol abusers : Education Category	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	Within 3 days after enrollment in the study	No
Secondary	Socio-economic characteristics of alcohol abusers : Way of life	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	Within 3 days after enrollment in the study	No

External Links

•   French article written by the French Alcohology Society about alcohol misuse, screening, diagnostic and treatment - Alcohology and addictology
•   French article written by the French Alcohology Society and the French Geriatrics and Gerontology Society about the elderly and alcohol consumption