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Type 1 Diabetes Recurrence in Pancreas Transplants

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ClinicalTrials.gov Identifier: NCT01047865
Recruitment Status : Recruiting
First Posted : January 13, 2010
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
George W. Burke, University of Miami

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.

Condition or disease
Diabetes Mellitus, Type 1

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.


Study Type : Observational
Estimated Enrollment : 295 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Recurrence of T1D in Pancreas Transplantation
Study Start Date : May 2005
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
pancreas-kidney transplant
pancreas-kidney transplant recipients with type 1 diabetes.



Primary Outcome Measures :
  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: monthly ]

Secondary Outcome Measures :
  1. Monitor autoantibody levels as well as phenotype autoreactive T cells in peripheral blood. [ Time Frame: monthly ]

Biospecimen Retention:   Samples Without DNA
peripheral blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047865


Contacts
Contact: George Burke, M.D. 305-355-5111 gburke@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

Publications:

Responsible Party: George W. Burke, Professor of Surgery, University of Miami
ClinicalTrials.gov Identifier: NCT01047865     History of Changes
Other Study ID Numbers: 20053039
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by George W. Burke, University of Miami:
Type 1 Diabetes (T1D)
Autoimmunity

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