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Islet Transplantation in Type 1 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT00214253
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

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
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

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): 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
First Posted: September 21, 2005    Key Record Dates
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