Risk Factors for Type 1 Diabetes Recurrence in Immunosuppressed Recipients of Simultaneous Pancreas-Kidney Transplants.
F Vendrame, Y-Y Hopfner, S Diamantopoulos...
https://pubmed.ncbi.nlm.nih.gov/26317167Actively Recruiting
Led by University of Miami · Updated on 2025-01-16
400
Participants Needed
1
Research Sites
1095 weeks
Total Duration
Researchers are investigating the factors linked to the return of type 1 diabetes in people who have received a simultaneous pancreas-kidney (SPK) or pancreas transplant. They aim to determine if specific immune responses, including humoral and cellular islet-specific reactions, serve as early warning signs for the recurrence of autoimmunity and high blood sugar after transplantation. The study will evaluate these immune responses both individually and combined to predict disease return. The study includes retrospective analysis of SPK transplant recipients to measure how often and when autoantibodies reappear, and to assess their ability to predict diabetes recurrence. Prospectively, the study will follow current and new pancreas transplant recipients monthly for 24 months to monitor levels of autoantibodies and to examine autoreactive T cells in the blood. For those with persistent autoantibodies, biopsies of the transplanted pancreas will be performed to look for insulitis and to analyze the pancreatic immune cells. Participants will be involved for 24 months during which their blood will be regularly tested to track immune markers. Biopsies of the transplanted pancreas may be taken for further examination in cases of consistent autoimmune activity. The main outcomes include measuring the frequency and timing of autoantibody return and ongoing immune cell monitoring to understand the autoimmune process after pancreas transplantation.
CONDITIONS
Type 1 Diabetes Recurrence in Pancreas Transplants
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Total: 1 location
1
University of Miami Miller School of Medicine Transplant Clinic
Miami, Florida, United States, 33136
Actively Recruiting
G
George Burke, M.D.
L
Lissett Moni
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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