NCT06714786

Brief Summary

The study aims to evaluate the presence of eating disorders, which consists of having an altered relationship with food, in patients on the list or already undergoing liver transplantation.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2021

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 4, 2024

Status Verified

October 1, 2024

Enrollment Period

4.7 years

First QC Date

November 28, 2024

Last Update Submit

November 28, 2024

Conditions

Liver Transplant

Outcome Measures

Primary Outcomes (1)

  • eating disorder

    prevalence of eating disorders measured through validated questionnaires

    at the time of enrollment

Eligibility Criteria

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

The study involves the enrollment of at least 100 patients, currently followed for the treatment of severe organ failure, on the list or already undergoing liver transplantation and referred for a dietetic visit.

You may qualify if:

  • signature of written informed consent to participate in the observational study, either by the participant or legal guardian
  • age \> 18 years
  • diagnosis of type 2 diabetes mellitus and/or overweight or obesity, (BMI \> 25)
  • be listed for OLT or have already been submitted to OLT

You may not qualify if:

  • previous diagnosis of psychiatric illness;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Sant'Orsola

Bologna, BO, 40138, Italy

Location

Study Officials

  • Lucia Brodosi, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 4, 2024

Study Start

April 30, 2021

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

December 4, 2024

Record last verified: 2024-10

Locations

IT(1)