NCT06816303

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

November 19, 2021

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 10, 2025

Status Verified

October 1, 2024

Enrollment Period

3.6 years

First QC Date

November 28, 2024

Last Update Submit

February 6, 2025

Conditions

Diabetes Mellitus Type 2Liver Transplant

Outcome Measures

Primary Outcomes (1)

  • glycosilated hemoglobin (%)

    glycometabolic control in relation to therapy

    through study completion, an average of 5 years

Secondary Outcomes (1)

  • degree of satisfaction with therapy

    through study completion, an average of 5 years

Eligibility Criteria

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

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

You may qualify if:

  • 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

You may not qualify if:

  • \- Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucia Brodosi

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lucia Brodosi

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia Brodosi

CONTACT

+39 0512143248lucia.brodosi2@unibo.it

Study Design

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

Study Record Dates

First Submitted

November 28, 2024

First Posted

February 10, 2025

Study Start

November 19, 2021

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 10, 2025

Record last verified: 2024-10

Locations

IT(1)