Patients With Diabetes Mellitus on Drug Treatment on the... | NCT06816303

Studies
Patients With Diabetes Mellitus on Drug Treatment on the List or Already Undergoing Orthotopic Liver Transplantation

NCT06816303

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Recruiting

Last Update Posted

Feb 10, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Diabetes Mellitus Type 2
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

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2021Actual

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Nov 28, 2024

First Submission Date that Met QC Criteria

Feb 6, 2025

First Posted Date

Feb 10, 2025Actual

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

Feb 6, 2025

Last Update Posted Date

Feb 10, 2025Actual

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

observational study through which we aim to collect information on metabolic compensation, the degree of satisfaction with hypoglycemic therapy, the onset of complications of diabetes or liver disease, evaluation of survival, in patients on the list for at least three months or already undergoing liver transplantation for at least three months

Detailed Description

Not provided

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
glycosilated hemoglobin (%)	glycometabolic control in relation to therapy	through study completion, an average of 5 years

Secondary Outcomes

Measure	Description	Time Frame
degree of satisfaction with therapy	degree of satisfaction with therapy through the administration of Diabetes Treatment Satisfaction Questionnaire (DTSQ)	through study completion, an average of 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

type 2 diabetes mellitus
presence on the list for OLT for at least 3 months or have already been submitted to OLT for at least 3 months
age ≥ 18 years
signature of written informed consent to participate in the observational study, either by the participant or legal guardian

Exclusion Criteria:

- Pregnancy or breastfeeding

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

patients followed for hepatological problems on the list for OLT or post-transplant with type 2 diabetes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lucia Brodosi	Contact	+39 0512143248		lucia.brodosi2@unibo.it

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lucia Brodosi	Recruiting	Bologna	BO	40138	Italy

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided