Type 1 Diabetes Recurrence in Pancreas Transplants
The hypothesis is that humoral and cellular islet-specific responses are an early risk factor for recurrence of autoimmunity and hyperglycemia in simultaneous pancreas-kidney (SPK) recipients independent of alloimmunity. This study will test the hypothesis and will assess their individual and combined predictive value.
|Study Design:||Observational Model: Cohort|
|Official Title:||Recurrence of T1D in Pancreas Transplantation|
- 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 [ Time Frame: monthly ] [ Designated as safety issue: No ]
- Monitor autoantibody levels as well as phenotype autoreactive T cells in peripheral blood. [ Time Frame: monthly ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
pancreas-kidney transplant recipients with type 1 diabetes.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047865
|Contact: George Burke, M.D.||firstname.lastname@example.org|
|United States, Florida|
|University of Miami Miller School of Medicine Transplant Clinic||Recruiting|
|Miami, Florida, United States, 33136|
|Principal Investigator: George Burke, M.D.|
|Principal Investigator:||George Burke, M.D.||University of Miami|