Islet Transplantation in Type 1 Diabetic Patients

Type 1 Diabetes Clinical Trial

Official title:

Islet Transplantation in Type 1 Diabetic Patients Using a Steroid-free Immunosuppression Protocol and Thiazolidinedione Insulin Sensitizers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214253
• Other study ID #: 2001-529
• Status: Completed
• Phase: Phase 1
• First received: September 14, 2005
• Last updated: March 29, 2017
• Start date: February 2002
• Est. completion date: October 2011

Study information

• Verified date: March 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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%

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Drug:
• Thiazolidinedione
Thiazolidinedione vs. no intervention with standard immunosuppression using Edmonton Protocol

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of islets necessary to achieve adequate metabolic control		5 years
Primary	post-transplant islet function		5 years
Secondary	Suitability of cadaver donor pancreases for islet transplantation		5 years