NCT06093919

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 12, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

October 17, 2023

Last Update Submit

August 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Prevalence for binge eating disorder in liver transplant patients following alcoholic cirrhosis

    1 year

  • Correlation between the BulimiaTest-Revised score and liver damage determined by the Fibroscan

    1 year

  • Correlation between the Bulimia-Test score and the Alcohol Use Disorders Identification Test-Consumption score

    1 year

Study Arms (1)

Liver transplant patients

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Henri Laborit

Poitiers, France

Location

University Hospital of Poitiers (CHU de Poitiers)

Poitiers, France

Location

MeSH Terms

Conditions

Feeding and Eating DisordersBinge-Eating DisorderAlcoholismLiver Cirrhosis, Alcoholic

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersLiver CirrhosisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicFibrosisPathologic ProcessesAlcohol-Induced Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 23, 2023

Study Start

February 12, 2024

Primary Completion

June 30, 2024

Study Completion

August 14, 2024

Last Updated

August 20, 2024

Record last verified: 2024-08

Locations