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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pancreas-kidney transplant | pancreas-kidney transplant recipients with type 1 diabetes. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Antibody recurrence | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Monitor autoantibody levels as well as phenotype autoreactive T cells in peripheral blood. | Antibodies levels | up to 15 years |
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Inclusion Criteria:
Exclusion Criteria:
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Type 1 diabetes who received a simultaneous pancreas-kidney (SPK) transplant
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| Name | Affiliation | Role |
|---|---|---|
| George Burke, M.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine Transplant Clinic | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26317167 | Result | Vendrame F, Hopfner YY, Diamantopoulos S, Virdi SK, Allende G, Snowhite IV, Reijonen HK, Chen L, Ruiz P, Ciancio G, Hutton JC, Messinger S, Burke GW 3rd, Pugliese A. Risk Factors for Type 1 Diabetes Recurrence in Immunosuppressed Recipients of Simultaneous Pancreas-Kidney Transplants. Am J Transplant. 2016 Jan;16(1):235-45. doi: 10.1111/ajt.13426. Epub 2015 Aug 28. | |
| 26547222 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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peripheral blood
| Burke GW 3rd, Vendrame F, Virdi SK, Ciancio G, Chen L, Ruiz P, Messinger S, Reijonen HK, Pugliese A. Lessons From Pancreas Transplantation in Type 1 Diabetes: Recurrence of Islet Autoimmunity. Curr Diab Rep. 2015 Dec;15(12):121. doi: 10.1007/s11892-015-0691-5. |
| 25142715 | Result | Pugliese A, Vendrame F, Reijonen H, Atkinson MA, Campbell-Thompson M, Burke GW. New insight on human type 1 diabetes biology: nPOD and nPOD-transplantation. Curr Diab Rep. 2014 Oct;14(10):530. doi: 10.1007/s11892-014-0530-0. |
| 24325575 | Result | Pugliese A, Yang M, Kusmarteva I, Heiple T, Vendrame F, Wasserfall C, Rowe P, Moraski JM, Ball S, Jebson L, Schatz DA, Gianani R, Burke GW, Nierras C, Staeva T, Kaddis JS, Campbell-Thompson M, Atkinson MA. The Juvenile Diabetes Research Foundation Network for Pancreatic Organ Donors with Diabetes (nPOD) Program: goals, operational model and emerging findings. Pediatr Diabetes. 2014 Feb;15(1):1-9. doi: 10.1111/pedi.12097. Epub 2013 Dec 10. |
| 22946986 | Result | Ciancio G, Sageshima J, Chen L, Gaynor JJ, Hanson L, Tueros L, Montenora-Velarde E, Gomez C, Kupin W, Guerra G, Mattiazzi A, Fornoni A, Pugliese A, Roth D, Wolf M, Burke GW 3rd. Advantage of rapamycin over mycophenolate mofetil when used with tacrolimus for simultaneous pancreas kidney transplants: randomized, single-center trial at 10 years. Am J Transplant. 2012 Dec;12(12):3363-76. doi: 10.1111/j.1600-6143.2012.04235.x. Epub 2012 Sep 4. |
| D004700 | Endocrine System Diseases |
| D007154 | Immune System Diseases |