Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434811
Status:
COMPLETED
Last Update Posted:
2019-07-17
First Post:
2007-02-09
Brief Title:
Islet Transplantation in Type 1 Diabetes
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Islet Transplantation in Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2019-07
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:
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed resulting in poor blood sugar control The purpose of this study is to determine the safety and effectiveness of islet transplantation combined with immunosuppressive medications for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes
Detailed Description:
Type 1 diabetes is commonly treated with the administration of insulin either by multiple insulin injections or by a continuous supply of insulin through a wearable pump Insulin therapy allows long-term survival in individuals with type 1 diabetes however it does not guarantee constant normal blood sugar control Because of this long-term type 1 diabetic survivors often develop vascular complications such as diabetic retinopathy an eye disease that can cause poor vision and blindness and diabetic nephropathy a kidney disease that can lead to kidney failure Some individuals with type 1 diabetes develop hypoglycemia unawareness a life-threatening condition that is not easily treatable with medication and is characterized by reduced or absent warning signals for hypoglycemia For such individuals transplantation of pancreatic islets is a possible treatment option Unfortunately insulin independence among islet transplant recipients tends to decline over time New strategies aimed at promoting engraftment of transplanted islets are needed to improve the clinical outcomes associated with this procedure The purpose of this study is determine the safety and efficacy of islet transplantation when combined with an immunosuppressive medication regimen for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes This study will also seek to improve the understanding of determinants of success and failure of islet transplants for type 1 diabetes
Eligible participants will be randomly assigned to this study or a site-specific Phase 2 islet transplantation study Participants in this study will receive up to three separate islet transplants and a regimen of immunosuppressive medications consisting of antithymocyte globulin ATG sirolimus and low-dose tacrolimus
Transplantations will involve an inpatient hospital stay and infusion of islets into a branch of the portal vein Participants who do not achieve or maintain insulin independence by Day 75 post-transplant will be considered for a second islet transplant Participants who remain dependent on insulin for longer than 1 month after the second transplant and who show partial graft function will be considered for a third islet transplant Basiliximab will be used in place of ATG for the second and third transplants if they are necessary Participants who do not meet the criteria for a subsequent transplant and do not have a functioning graft will enter a reduced follow-up period
There will be up to 19 study visits following each transplant A physical exam review of adverse events and blood collection will occur at most visits A chest x-ray abdominal ultrasound electrocardiogram quality of life questionnaires urine collection and glomerular filtrating rate GFR testing will occur at some visits Participants will also test their own blood glucose levels at least five times per day throughout the study A 24-month follow-up period will take place after the participants last transplant
Eligible participants will be randomly assigned to this study or a site-specific Phase 2 islet transplantation study Participants in this study will receive up to three separate islet transplants and a regimen of immunosuppressive medications consisting of antithymocyte globulin ATG sirolimus and low-dose tacrolimus
Transplantations will involve an inpatient hospital stay and infusion of islets into a branch of the portal vein Participants who do not achieve or maintain insulin independence by Day 75 post-transplant will be considered for a second islet transplant Participants who remain dependent on insulin for longer than 1 month after the second transplant and who show partial graft function will be considered for a third islet transplant Basiliximab will be used in place of ATG for the second and third transplants if they are necessary Participants who do not meet the criteria for a subsequent transplant and do not have a functioning graft will enter a reduced follow-up period
There will be up to 19 study visits following each transplant A physical exam review of adverse events and blood collection will occur at most visits A chest x-ray abdominal ultrasound electrocardiogram quality of life questionnaires urine collection and glomerular filtrating rate GFR testing will occur at some visits Participants will also test their own blood glucose levels at least five times per day throughout the study A 24-month follow-up period will take place after the participants last transplant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None