Type 1 Diabetes Recurrence in Pancreas Transplants
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01047865|
Recruitment Status : Recruiting
First Posted : January 13, 2010
Last Update Posted : May 4, 2018
|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 :||400 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047865
|Contact: George Burke, M.D.||email@example.com|
|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|