Type 1 Diabetes Recurrence in Pancreas Transplants

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01047865
Study type	Observational
Source	University of Miami
Contact	George Burke, M.D.
Phone	305-355-5111
Email	gburke@med.miami.edu
Status	Recruiting
Phase
Start date	May 2005
Completion date	May 2025

View Details

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