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

Sponsor
Centre Hospitalier Henri Laborit (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06093919
Collaborator
(none)
250
2
14
125
9

Study Details

Study Description

Brief 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

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Study of Prevalence of Eating Disorder in Liver Transplant Patients
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Liver transplant patients

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

Outcome Measures

Primary Outcome Measures

  1. Prevalence of binge eating disorder in liver transplant patients [1 year]

    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.

Secondary Outcome Measures

  1. Prevalence for binge eating disorder in liver transplant patients following alcoholic cirrhosis [1 year]

    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.

  2. Correlation between the BulimiaTest-Revised score and liver damage determined by the Fibroscan [1 year]

    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.

  3. Correlation between the Bulimia-Test score and the Alcohol Use Disorders Identification Test-Consumption score [1 year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Henri Laborit Poitiers France
2 University Hospital of Poitiers (CHU de Poitiers) Poitiers France

Sponsors and Collaborators

  • Centre Hospitalier Henri Laborit

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Henri Laborit
ClinicalTrials.gov Identifier:
NCT06093919
Other Study ID Numbers:
  • F20230719110020
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023