Type 1 Diabetes Recurrence in Pancreas Transplants
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|ClinicalTrials.gov Identifier: NCT01047865|
Recruitment Status : Recruiting
First Posted : January 13, 2010
Last Update Posted : June 14, 2017
|Condition or disease|
|Diabetes Mellitus, Type 1|
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.
|Study Type :||Observational|
|Estimated Enrollment :||295 participants|
|Official Title:||Recurrence of T1D in Pancreas Transplantation|
|Study Start Date :||May 2005|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
pancreas-kidney transplant recipients with type 1 diabetes.
- 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 ]
- Monitor autoantibody levels as well as phenotype autoreactive T cells in peripheral blood. [ Time Frame: monthly ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|