Observational Study of Eating Behavior in Patients With D... | NCT06714786

Studies
Observational Study of Eating Behavior in Patients With Diabetes Mellitus and Obesity Undergoing Liver Transplantation

NCT06714786

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Active, not recruiting

Last Update Posted

Dec 4, 2024Actual

Enrollment

69Estimated

Phase

Not provided

Conditions

Liver Transplant

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2021Actual

Primary Completion Date

Jan 2026Estimated

Completion Date

Jan 2026Estimated

First Submitted Date

Nov 28, 2024

First Submission Date that Met QC Criteria

Nov 28, 2024

First Posted Date

Dec 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2024

Last Update Posted Date

Dec 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

69Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
eating disorder	prevalence of eating disorders measured through validated questionnaires	at the time of enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-previous diagnosis of psychiatric illness;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lucia Brodosi, MD	IRCCS Azienda Ospedaliero-Universitaria di Bologna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Sant'Orsola		Bologna	BO	40138	Italy