A Phase 1 interventional study of Thiazolidinedione in Type 1 Diabetes, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-03-31.
Sponsored by University of Wisconsin, Madison · Phase 1, Interventional, and Treatment
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?
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 14 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of Wisconsin, Madison is the lead sponsor of 1,182 studies on the registry; 180 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 118 (76%) have results posted.
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Exclusion Criteria:
Thiazolidinedione therapy
Drug: Thiazolidinedione
Thiazolidinedione vs. no intervention with standard immunosuppression using Edmonton Protocol
number of islets necessary to achieve adequate metabolic control
Time frame: 5 years
post-transplant islet function
Time frame: 5 years
Suitability of cadaver donor pancreases for islet transplantation
Time frame: 5 years
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: 2,4-thiazolidinedione
University of Wisconsin, Madison →