Type 1 Diabetes Recurrence in Pancreas Transplants
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Recurrence of T1D in Pancreas Transplantation |
- 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 ]
- 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 |
| 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 |
Type 1 diabetes who received a simultaneous pancreas-kidney (SPK) transplant
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| Contact: George Burke, M.D. | 305-355-5111 | gburke@med.miami.edu |
| Contact: Lois Hanson, R.N. | 305-355-5315 | lhanson2@med.miami.edu |
| United States, Florida | |
| University of Miami Miller School of Medicine Transplant Clinic | Recruiting |
| Miami, Florida, United States, 33136 | |
| Principal Investigator: George Burke, M.D. | |
| 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: | November 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Miami:
|
Type 1 Diabetes (T1D) Autoimmunity |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 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 May 16, 2013