Type 1 Diabetes
Conditions
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?
Interventions
Thiazolidinedione vs. no intervention with standard immunosuppression using Edmonton Protocol
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of islets necessary to achieve adequate metabolic control | 5 years |
| post-transplant islet function | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Suitability of cadaver donor pancreases for islet transplantation | 5 years |
Countries
United States
Outcome results
None listed