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Not recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT01047865

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Study ID

NCT01047865

Start date

May, 2005

Status verified date

Jan, 2025

Completion date

Jan 5, 2026

Primary completion date

Jan 5, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

238 participants

Interventions and Outcome Measures

Arms

pancreas-kidney transplant

pancreas-kidney transplant recipients with type 1 diabetes.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

More Information

Sponsor

University of Miami

Last update posted

May 29, 2026

Last verified

Jan, 2025

Keywords

  • Type 1 Diabetes (T1D)
  • Autoimmunity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by University of Miami on 2026-05-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.