Islet Transplantation in Type 1 Diabetic Patients

Phase 1

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Thiazolidinedione

• Registration Number: NCT00214253
• Lead Sponsor: University of Wisconsin, Madison

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-21
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Thiazolidinedione	Thiazolidinedione therapy

Primary Outcome Measures

Name	Time	Method
number of islets necessary to achieve adequate metabolic control	5 years
post-transplant islet function	5 years

Secondary Outcome Measures

Name	Time	Method
Suitability of cadaver donor pancreases for islet transplantation	5 years

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States