Effects of liver transplantation on diabetes in cirrhosis patients
Insulin Secretion and Sensitivity in Subjects With Liver Cirrhosis Undergoing Orthotopic Liver Transplantation (OLT): Pre- and Post-OLT Analysis
This study is testing how getting a liver transplant affects blood sugar control and diabetes in people with liver cirrhosis over the next ten years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT02038517 on ClinicalTrials.gov |
What this trial studies
This observational study assesses insulin secretion and sensitivity in patients with liver cirrhosis who are undergoing orthotopic liver transplantation (OLT). It utilizes mathematical modeling based on oral glucose tolerance tests conducted before and at various time points after the transplantation. The study aims to understand how OLT affects glucose metabolism and the potential development or persistence of diabetes-related abnormalities over a 10-year follow-up period.
Who should consider this trial
Good fit: Ideal candidates are individuals with end-stage liver cirrhosis who are on the waiting list for orthotopic liver transplantation.
Not a fit: Patients with known diabetes, cystic fibrosis, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of diabetes in patients with liver cirrhosis post-transplantation.
How similar studies have performed: While this approach is observational and builds on existing knowledge, similar studies have shown that liver transplantation can significantly impact metabolic conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects with end-stage liver cirrhosis in waiting list for orthotopic liver transplantation at the Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milan, Italy Exclusion Criteria: * Known diabetes * Cystic fibrosis * Pregnancy
Where this trial is running
Milan, MI
- Endocrinology and Diabetes Unit, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico — Milan, Mi, Italy (Recruiting)
Study contacts
- Principal investigator: Emanuela Orsi, MD — Endocrinology and Diabetes Unit, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milan, Italy
- Study coordinator: Emanuela Orsi, MD
- Email: e.orsi@policlinico.mi.it
- Phone: +390255034590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.