Actively Recruiting

Age: 18Years - 65Years
All Genders
ID02038517

Insulin Secretion and Sensitivity in Liver Cirrhosis Patients Undergoing Orthotopic Liver Transplantation: Pre- and Post-Transplant Analysis

Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2016-03-01

200

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on people with liver cirrhosis who are awaiting or have undergone orthotopic liver transplantation (OLT). The study aims to evaluate insulin secretion and sensitivity by using mathematical models derived from oral glucose tolerance tests taken before and at several points after the transplantation. It also explores how changes in insulin function relate to the development or persistence of glucose metabolism issues over a 10-year follow-up. Additionally, it examines links between insulin changes and health outcomes like morbidity, mortality, and metabolic syndrome components such as obesity, dyslipidemia, and hypertension. Participants are monitored through routine clinical and laboratory tests, including glucose, insulin, and C-peptide levels measured at multiple time intervals during an oral glucose tolerance test. These tests are routinely performed before and after OLT. Data on cardiovascular risk factors, events, renal function, treatments, and other illnesses are also collected. The study follows patients for at least 10 years with yearly visits and death record consultations if participants drop out. Throughout the study, researchers track insulin secretion and sensitivity changes to understand their relationship with glucose metabolism abnormalities after transplantation. They also observe long-term health outcomes related to cardiovascular and metabolic conditions. This observational study was approved by the Ethics Committee and began data transfer in 2013, continuing with ongoing patient follow-up visits for comprehensive monitoring.

CONDITIONS

Brief Title

Cirrhosis, Effects of TRAnsplantation and Diabetes

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Diagnosed with end-stage liver cirrhosis
  • On the waiting list for orthotopic liver transplantation at Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milan, Italy
Not Eligible

You will not qualify if you...

  • Known diagnosis of diabetes
  • Diagnosis of cystic fibrosis
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Pre-transplant and at various time points post-transplant over 10 years

Participants undergo oral glucose tolerance tests and routine clinical and laboratory assessments before and after orthotopic liver transplantation to evaluate insulin secretion and sensitivity.

At least yearly visits for up to 10 years

Long-term Monitoring

Duration - Up to 10 years

Participants are followed for up to 10 years with yearly visits to monitor glucose metabolism, cardiovascular risk factors, renal function, morbidity, and mortality.

Yearly visits for up to 10 years

Trial Site Locations

Total: 1 location

1

Endocrinology and Diabetes Unit, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico

Milan, MI, Italy, 20122

Actively Recruiting

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Research Team

E

Emanuela Orsi, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Central role of the β-cell in driving regression of diabetes after liver transplantation in cirrhotic patients.

Valeria Grancini, Maddalena Trombetta, Maria Elena Lunati...

https://pubmed.ncbi.nlm.nih.gov/30677460