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/30677460Actively Recruiting
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2016-03-01
200
Participants Needed
1
Research Sites
521 weeks
Total Duration
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
Cirrhosis, Effects of TRAnsplantation and Diabetes
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Endocrinology and Diabetes Unit, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico
Milan, MI, Italy, 20122
Actively Recruiting
E
Emanuela Orsi, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Valeria Grancini, Maddalena Trombetta, Maria Elena Lunati...
https://pubmed.ncbi.nlm.nih.gov/30677460