Islet Transplantation in Type 1 Diabetic Patients

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Our hypothesis is that a successful clinical islet transplant program can be established at the University of Wisconsin using a steroid -free, sirolimus- and low dose tacrolimus - based immunosuppressive drug regimen (Edmonton protocol). We intend to answer the following research questions: 1) will treatment of islet transplant recipients with thiazolidinediones (i.e. pioglitazone) enhance post-transplant islet function and reduce the number of islets necessary to achieve adequate metabolic control? 2) which type 1 diabetic patients are optimal candidates for islet transplantation (i.e. islet transplant alone or islet after kidney transplantation)? 3) Can cadaver donor pancreases, which are ordinarily discarded and not used for pancreas transplantation be used for islet transplantation?

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes	Drug: Thiazolidinedione	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	14 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Islet Transplantation in Type 1 Diabetic Patients Using a Steroid-free Immunosuppression Protocol and Thiazolidinedione Insulin Sensitizers
Study Start Date :	February 2002
Actual Primary Completion Date :	October 2011
Actual Study Completion Date :	October 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; Thiazolidinedione therapy	Drug: Thiazolidinedione; Thiazolidinedione vs. no intervention with standard immunosuppression using Edmonton Protocol
No Intervention: 2

Outcome Measures

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Primary Outcome Measures :

1. number of islets necessary to achieve adequate metabolic control [ Time Frame: 5 years ]
2. post-transplant islet function [ Time Frame: 5 years ]

Secondary Outcome Measures :

1. Suitability of cadaver donor pancreases for islet transplantation [ Time Frame: 5 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 16 Type I insulin-dependent diabetic subjects ages 18-60,(8 who have received a prior kidney or liver transplant and have stable renal function, and 8 who have labile glucose regulation and who have failed a trial of intensive exogenous insulin therapy and who have preserved native renal function)

Exclusion Criteria:

• untreated proliferative diabetic retinopathy;
• HgbA1C >12%; creatinine clearance < 80 ml/minute or macroalbuminuria > 0.3 gm/24 hrs;
• presence of panel reactive antibodies >20%

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:	Jon Odorico, MD	University of Wisconsin, Madison

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00214253 History of Changes
Other Study ID Numbers:	2001-529
First Posted:	September 21, 2005
Last Update Posted:	March 31, 2017
Last Verified:	March 2017

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases	Autoimmune Diseases; Immune System Diseases; 2,4-thiazolidinedione; Hypoglycemic Agents; Physiological Effects of Drugs