Benefit of Carbohydrate Deficient Transferrin to Detect Chronic Alcohol Abuse in the Elderly. A French Multicentered Prospective Interventional Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 194
- Locations
- 4
- Primary Endpoint
- Benefit of Carbohydrate Deficient Transferrin to detect chronic alcohol abuse in the elderly compared to usual clinical detection tools
Study Overview
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").
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Alcohol Used Disorders Identification Test (AUDIT C) (Behavioral)
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.
Intervention: Carbohydrate deficient transferrin (Procedure)
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.
Intervention: Gamma glutamyl transpeptidase (Procedure)
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.
Intervention: Mean Corpuscular Volume (Procedure)
Outcomes
Primary Outcomes
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
- Socio-economic characteristics of alcohol abusers : Socioprofessional category(Within 3 days after enrollment in the study)
- 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)
- Socio-economic characteristics of alcohol abusers : Way of life(Within 3 days after enrollment in the study)
- 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)
- Socio-economic characteristics of alcohol abusers : Education Category(Within 3 days after enrollment in the study)