TrialPath
← Back to searchRecruiting

Type 1 Diabetes Recurrence in Pancreas Transplants

NCT01047865 · University of Miami
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Recurrence of T1D in Pancreas Transplantation
About this study
To identify the factors associated with recurrence of diabetes in subjects who received a simultaneous pancreas-kidney (SPK) or pancreas transplant. The study will see if there are changes in the participant's blood that will help the investigator know whether diabetes has returned after the transplant. SPK patients will be retrospectively analyzed to determine frequency, levels and time course of autoantibody recurrence and predictive value of autoantibodies for recurrence of the disease. This study will prospectively follow our existing and our new pancreas transplant recipients to monitor autoantibody levels, monitor and phenotype autoreactive T cells in peripheral blood. This will happen monthly for 24 months. This study will assess the presence or absence of insulitis in the transplanted pancreas from biopsies performed in recipients with consistent recurrence of multiple autoantibodies. It will also monitor and phenotype autoreactive T cells from the pancreatic infiltrate obtained by pancreatic transplant biopsies.
Eligibility 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.
Study design
Enrollment target: 400 participants
Age groups: adult, older_adult
Timeline
Starts: 2005-05
Estimated completion: 2026-05
Last updated: 2025-01-16
Primary outcomes
  • Retrospective and prospective analysis of pancreas transplant recipients to determine frequency, and time course of autoantibody recurrence of disease. Prospective follow up to: monitor autoantibody levels, monitor and phenotype autoreactive T (up to 5 years)
Sponsor
University of Miami · other
Contacts & investigators
ContactGeorge Burke, M.D. · contact · gburke@med.miami.edu · 305-355-5111
ContactLissett Moni · contact · ltueros@med.miami.edu · 3053555728
InvestigatorGeorge Burke, M.D. · principal_investigator, University of Miami
All locations (1)
University of Miami Miller School of Medicine Transplant ClinicRecruiting
Miami, Florida, United States