Patients With Diabetes Mellitus on Drug Treatment on the List or Already Undergoing Orthotopic Liver Transplantation (DiaBoLT2021)

February 6, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Adult Patients With Diabetes Mellitus, on Drug Treatment, on the List or Already Undergoing Orthotopic Liver Transplantation: an Observational Study

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Lucia Brodosi, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2021

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DiaBoLT2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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