Study of Prevalence of Eating Disorder in Liver Transplant Patients (Pré-THETA)

The main goal of this observational study is to measure the prevalence of binge eating disorder in liver transplant patients by evaluating the responses to the Bulimia Test.

Secondary objectives of the study are to:

• Determine the prevalence of binge eating disorders in liver transplant patients following alcoholic cirrhosis, evaluated by the Bulimia Test;
• Study the association between the presence of eating disorder behaviours and liver damage : hepatic steatosis and fibrosis determined by Fibroscan (Transient elastography and controlled attenuation parameter)
• Study the association between presence of eating disorder behaviours and alcohol use disorder, measured by Alcohol Use Disorders Identification Test-Consumption

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder; Liver Transplant; Complications; Eating Disorders; Cirrhosis Alcoholic; Eating Disorder Binge

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• France
  • Poitiers, France
    • Centre Hospitalier Henri Laborit
  • Poitiers, France
    • University Hospital of Poitiers (CHU de Poitiers)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of all liver transplant patients at the University Hospital of Poitiers followed between 01/01/2023 and 06/30/2024

Description

Inclusion Criteria:

• over 18 years old
• had a liver transplant and followed at University Hospital of Poitiers
• responded to the Bulimia Test-Revised and to the Alcohol Use Disorders Identification Test-Consumption
• had a Fibroscan within the year

Exclusion Criteria:

• Patient without Fibroscan and not responded to both scale : Bulimia Test-Revised and Alcohol Use Disorders Identification Test-Consumption

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Liver transplant patients; This cohort will consist of all liver transplant patients followed between 01/01/2023 and 06/30/2024

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of binge eating disorder in liver transplant patients	The prevalence is defined as the percentage of liver transplant patients with a score higher than 88 on the Bulimia Test-Revised. The Bulimia Test-Revised is a validated test. It is a 36 item self-report questionnaire to assess the presence of bulimic symptoms. Scores range from 29-140 with those greater than 104 being indicative of bulimia nervosa.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence for binge eating disorder in liver transplant patients following alcoholic cirrhosis	The prevalence was defined as the percentage of liver transplant patients following alcoholic cirrhosis with a score higher than 88 on the Bulimia Test-Revised. The Bulimia Test-Revised is a validated test. It is a 36 item self-report questionnaire to assess the presence of bulimic symptoms. Scores range from 29-140 with those greater than 104 being indicative of bulimia nervosa.	1 year
Correlation between the BulimiaTest-Revised score and liver damage determined by the Fibroscan	The Correlation was defined by the coefficient between the bulimia-Test score and the liver damage defined by the levels of hepatic steatosis and fibrosis witch are measured by Transient elastography and controlled attenuation parameter using Fibroscan. The Bulimia Test-Revised is a validated, it is a 36 item self-report questionnaire to assess the presence of bulimic symptoms. Scores range from 29-140 with those greater than 104 being indicative of bulimia nervosa.	1 year
Correlation between the Bulimia-Test score and the Alcohol Use Disorders Identification Test-Consumption score	The Correlation was defined by the coefficient between the bulimia-Test score and the Alcohol Use Disorders Identification Test-Consumption score. The Bulimia Test-Revised is a validated. It is a 36 item self-report questionnaire to assess the presence of bulimic symptoms. Scores range from 29-140 with those greater than 104 being indicative of bulimia nervosa. The Alcohol Use Disorders Identification Test-Consumption score is a validated test. It's scored on a scale of 0-12 (scores of 0 reflect no alcohol use). For men, a score of 4 or more is considered positive; for women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely the patient's drinking is affecting his/her health and safety.	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Henri Laborit

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): August 14, 2024

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Digestive System Diseases; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Liver Diseases; Fibrosis; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Liver Cirrhosis; Alcoholism; Feeding and Eating Disorders; Binge-Eating Disorder; Liver Cirrhosis, Alcoholic
• Other Study ID Numbers: F20230719110020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No