Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315588
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2006-04-14
Brief Title:
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
Sponsor:
Rodolfo Alejandro
Organization:
University of Miami
Study Overview
Official Title:
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01DK055347 | NIH | None | None |
| 5R01DK025802 | NIH | None | httpsreporternihgovquickSearch5R01DK025802 |