Investigating diabetes recurrence in pancreas transplant patients
Recurrence of T1D in Pancreas Transplantation
This study is trying to find out what causes Type 1 Diabetes to come back in people who have received a pancreas-kidney transplant by looking at their blood and pancreatic tissue over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT01047865 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify factors associated with the recurrence of Type 1 Diabetes in patients who have received simultaneous pancreas-kidney transplants. It will analyze blood samples to monitor autoantibody levels and autoreactive T cells over a 24-month period. Additionally, the study will assess pancreatic biopsies to evaluate the presence of insulitis in patients experiencing diabetes recurrence. The goal is to understand the predictive value of these immune responses for diabetes recurrence post-transplant.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have received a simultaneous pancreas-kidney transplant.
Not a fit: Patients who have received other organ transplants besides pancreas-kidney will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management strategies for diabetes recurrence in pancreas transplant recipients.
How similar studies have performed: While similar studies have explored autoimmunity in transplant patients, this specific approach to monitoring diabetes recurrence is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient has been fully informed and has signed a dated IRB approval informed consent form and is willing to follow study procedures for the extent of the study (24 months). Parent or legal guardian must provide written consent for patients \<18 years of age. * Age 18-75 years. * Recipient of simultaneous pancreas and kidney transplant * Primary or secondary renal allograft: living or deceased Exclusion Criteria: * Patient has previously received or is receiving an organ transplant other than a pancreas-kidney.
Where this trial is running
Miami, Florida
- University of Miami Miller School of Medicine Transplant Clinic — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: George Burke, M.D. — University of Miami
- Study coordinator: George Burke, M.D.
- Email: gburke@med.miami.edu
- Phone: 305-355-5111
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.