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Islet Transplantation in Type 1 Diabetic Patients

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status and phase

Completed
Phase 1

Conditions

Type 1 Diabetes

Treatments

Drug: Thiazolidinedione

Study type

Interventional

Funder types

Other

Identifiers

NCT00214253
2001-529

Details and patient eligibility

About

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?

Enrollment

14 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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%

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

14 participants in 2 patient groups

1
Experimental group
Description:
Thiazolidinedione therapy
Treatment:
Drug: Thiazolidinedione
2
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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