Type 1 Diabetes Recurrence in Pancreas Transplants

RECRUITING

I'm interested ...!!

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 Start (Actual) May 2005

🗓️ Primary Completion (Estimated) May 2025

✅ Study Completion (Estimated) May 2025

👥 Enrollment (Estimated) 400

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Miami, Florida, United States

📋 Eligibility Criteria

Description

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.

Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 12 January 2010
First Submitted that Met QC Criteria 12 January 2010
First Posted 13 January 2010

Study Record Updates

Last Update Submitted that Met QC Criteria 27 February 2024
Last Update Posted 28 February 2024
Last Verified February 2024