Study of Prevalence of Eating Disorder in Liver Transplant Patients

Alcohol Use Disorder Clinical Trial

— Pré-THETA  

Official title:

Study of Prevalence of Eating Disorder in Liver Transplant Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06093919
• Other study ID #: F20230719110020
• Status: Not yet recruiting
• Start date: February 12, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Henri Laborit
• Contact: Carole Wangermez, Dr
• Phone: 05.16.52.61.18
• Email: carole.wangermez[@]ch-poitiers.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Binge-Eating Disorder
• Eating Disorders
• Feeding and Eating Disorders
• Liver Cirrhosis, Alcoholic
• Liver Transplant; Complications

Locations

Country	Name	City	State
France	Centre Hospitalier Henri Laborit	Poitiers
France	University Hospital of Poitiers (CHU de Poitiers)	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Laborit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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