NCT00315588

Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Rodolfo Alejandro · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft.

Detailed description

1. To reverse hyperglycemia and insulin dependency by islet cell transplantation, in patients with Type 1 Diabetes Mellitus who have a stable kidney allograft; 2. To eliminate the incidence of hypoglycemic coma and unawareness by islet cell transplantation; 3. To assess long-term function of successful islet cell transplants; 4. To determine whether the natural history of the microvascular, macrovascular and neuropathic complications of Diabetes Mellitus are altered following successful transplantation of islet cells. 5. To assess the effect of exenatide to improve islet graft function and survival in subjects that demonstrate partial graft loss and have returned to using exogenous insulin. 6. To assess the ability of exenatide to improve islet survival at time of islet transplantation

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Islet Transplantation	Islet Transplantation in subjects with a previous kidney transplant.

Timeline

• Start date: 2000-12-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2006-04-18
• Last updated: 2017-04-12
• Results posted: 2017-04-12

Locations

1 site across 1 country: United States