Actively Recruiting

Age: 18Years - 75Years
All Genders
ID01047865

Recurrence of Type 1 Diabetes in Pancreas and Kidney Transplant Recipients Observational Study to Monitor Immune Responses and Autoantibody Levels Led by University of Miami

Led by University of Miami · Updated on 2025-01-16

400

Participants Needed

1

Research Sites

1095 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Type 1 Diabetes Recurrence in Pancreas Transplants

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient has been fully informed and has signed a dated IRB approval informed consent form and is willing to follow study procedures for the extent of the study (24 months)
  • Age 18-75 years
  • Recipient of simultaneous pancreas and kidney transplant
  • Primary or secondary renal allograft: living or deceased
Not Eligible

You will not qualify if you...

  • Patient has previously received or is receiving an organ transplant other than a pancreas-kidney

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Miami Miller School of Medicine Transplant Clinic

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

G

George Burke, M.D.

L

Lissett Moni

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Frequently Asked Questions

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Published Research Related To This Trial

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/26317167

The Juvenile Diabetes Research Foundation Network for Pancreatic Organ Donors with Diabetes (nPOD) Program: goals, operational model and emerging findings.

Alberto Pugliese, Mingder Yang, Irina Kusmarteva...

https://pubmed.ncbi.nlm.nih.gov/24325575

Advantage of rapamycin over mycophenolate mofetil when used with tacrolimus for simultaneous pancreas kidney transplants: randomized, single-center trial at 10 years.

G Ciancio, J Sageshima, L Chen...

https://pubmed.ncbi.nlm.nih.gov/22946986
Recurrence of Type 1 Diabetes in Pancreas and Kidney Transplant Recipients Observational Study to Monitor Immune Responses and Autoantibody Levels Led by University of Miami | DecenTrialz