Islet Transplantation in Type 1 Diabetic Patients

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT00214253

First received: September 14, 2005

Last updated: March 29, 2017

Last verified: March 2017

History of Changes

Purpose

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	Intervention	Phase
Type 1 Diabetes	Drug: Thiazolidinedione	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	Islet Transplantation in Type 1 Diabetic Patients Using a Steroid-free Immunosuppression Protocol and Thiazolidinedione Insulin Sensitizers

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Islet Cell Transplantation

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	14
Study Start Date:	February 2002
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Thiazolidinedione therapy	Drug: Thiazolidinedione Thiazolidinedione vs. no intervention with standard immunosuppression using Edmonton Protocol
No Intervention: 2

Eligibility


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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00214253

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


Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00214253 History of Changes
Other Study ID Numbers:	2001-529
Study First Received:	September 14, 2005
Last Updated:	March 29, 2017

Additional relevant MeSH terms:


2,4-thiazolidinedione Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 27, 2017

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