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OpenTrials
Completed

NCT Number: NCT01047865

Type 1 Diabetes Recurrence in Pancreas Transplants

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami Miller School of Medicine Transplant Clinic

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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). Parent or legal guardian must provide written consent for patients <18 years of age.
  • Age 18-75 years.
  • Recipient of simultaneous pancreas and kidney transplant
  • Primary or secondary renal allograft: living or deceased

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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: up to 5 years

    Antibody recurrence

Secondary outcomes

  1. Monitor autoantibody levels as well as phenotype autoreactive T cells in peripheral blood.

    Time frame: up to 15 years

    Antibodies levels

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Recurrence of T1D in Pancreas Transplantation

Important dates

Study start
2005
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2010
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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