Type 1 Diabetes Recurrence in Pancreas Transplants

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Miami
Sponsor:
Collaborators:
Information provided by (Responsible Party):
George W. Burke, University of Miami
ClinicalTrials.gov Identifier:
NCT01047865
First received: January 12, 2010
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Phase
Diabetes Mellitus, Type 1
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Recurrence of T1D in Pancreas Transplantation

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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: monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Monitor autoantibody levels as well as phenotype autoreactive T cells in peripheral blood. [ Time Frame: monthly ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

peripheral blood


Estimated Enrollment: 295
Study Start Date: May 2005
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
pancreas-kidney transplant
pancreas-kidney transplant recipients with type 1 diabetes.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Type 1 diabetes who received a simultaneous pancreas-kidney (SPK) transplant

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047865

Contacts
Contact: George Burke, M.D. 305-355-5111 gburke@med.miami.edu
Contact: Lois Hanson, R.N. 305-355-5315 lhanson2@med.miami.edu

Locations
United States, Florida
University of Miami Miller School of Medicine Transplant Clinic Recruiting
Miami, Florida, United States, 33136
Principal Investigator: George Burke, M.D.         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: George Burke, M.D. University of Miami
  More Information

No publications provided

Responsible Party: George W. Burke, Professor of Surgery, University of Miami
ClinicalTrials.gov Identifier: NCT01047865     History of Changes
Other Study ID Numbers: 5R01DK070011, 5R01DK070011
Study First Received: January 12, 2010
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Type 1 Diabetes (T1D)
Autoimmunity

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Recurrence
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes
Pathologic Processes
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014