Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133809
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2005-08-22
Brief Title:
Islet Transplantation in Type 1 Diabetics Using the Edmonton Protocol of Steroid Free Immunosuppression
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Islet Transplantation in Type 1 Diabetes Using the Edmonton Protocol of Steroid Free Immunosuppression
Status:
COMPLETED
Status Verified Date:
2016-06
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:
This trial will study the ability of islet transplantation to restore glycemic control and achieve insulin independence in type 1 diabetic subjects with life-threatening hypoglycemia and unawareness or recurrent hyperglycemia with ketoacidosis
Detailed Description:
LAY SUMMARY
More than 1 million North Americans have type 1 diabetes Each year approximately 30000 new cases of type 1 diabetes are diagnosed in the United States Type 1 diabetes destroys islets a cluster of cells within the pancreas that produce insulin Insulin is a hormone with many effects However the most important effect of insulin is to control the level of sugar in the blood People with Type 1 diabetes no longer produce insulin and must take insulin injections to live Despite steady improvements in the management of this disease its victims remain at increased risk for stroke heart attack kidney failure amputation blindness nerve damage and premature death The life expectancy of a teenager is reduced by thirty years from the time of onset of the disease Unfortunately many type 1 diabetics cannot control their blood sugars in spite of very careful monitoring and the frequent injection of insulin This group of patients is considered to have labile or brittle diabetes These brittle diabetics can often have wide swings in their blood sugar levels that can be life threatening Hypoglycemia or low blood sugars occurs when too much insulin is in the bloodstream When this occurs it is vital that patients eat or drink something right away that will increase their blood sugars Many diabetics lose the ability to recognize when their blood sugars are getting dangerously low These episodes of hypoglycemia can lead to coma and possibly death if not recognized and treated right away Patients can also experience extreme increases in blood sugars or hyperglycemia as a result of emotional or physical stress Hyperglycemia can result in dehydration confusion and a condition called ketoacidosis which can lead to death When this happens insulin must be given as soon as possible
Islet transplantation can restore the bodys ability to make insulin and in turn restore normal blood sugar levels
Since the 1960s doctors and scientists have attempted to replace this islet function by performing whole organ pancreas transplantation While the results of pancreas transplantation have improved dramatically in recent years this approach has largely been limited to patients with kidney disease who have also needed a kidney transplant This is because of the risks associated with the surgical procedure and the immunosuppressive drugs required to prevent rejection or the destruction of the transplanted pancreas by the bodys immune system Transplantation of a whole pancreas requires a major operation that is done through an incision in the abdomen The patient must be under general anesthesia or asleep for the entire procedure Recent clinical experience suggests that islet transplantation may be a useful approach to correct diabetes in humans
Islet transplantation offers a direct approach to the treatment of type 1 diabetes A large number of experimental studies carried out in many laboratories over the last decade have documented the beneficial effects of islet transplants in experimental animals These experiments have confirmed both the efficiency and safety of islet transplantation
The inability to isolate enough islets from a single pancreas has been one obstacle to successful islet transplantation A certain number of islets must be isolated or separated from a single pancreas in order to use them for transplant If this minimum number of islets is not obtained then the islets do not effectively reverse diabetes Progress in isolating the islets from a human pancreas has been dramatic in the last several years Advances in equipment and technology have lead to increases in the number of islets that can be isolated from a single pancreas
After successful isolation the islets can be injected through a catheter into the patients liver during a thirty-minute procedure A group of doctors at the University of Alberta in Edmonton Canada has had promising results in human islet transplantation Normal sugar levels have been documented after human islet transplants Also recent improvements in immunosuppressive drug treatments have resulted in sustained insulin-independence in selected type 1 diabetic patients The traditional method of transplant immunosuppression includes using some form of a steroid drug Steroids have been found to injure or kill the islets after transplant The doctors in Edmonton Canada established an immunosuppression formula that does not use steroids The objective of the study here at Emory University is to reproduce the successful results of human islet transplantation that have been achieved by the doctors at the University of Alberta using steroid free immunosuppression
The Emory Islet Transplant Program will enroll ten patients ages 18 to 65 in the study Each of the ten patients will receive at least 2 islet transplants from 2 different organ donors A third transplant may be required based on the patients insulin requirements after the 1st two transplants Each patient will be placed on immunosuppressive drugs to prevent the body from rejecting or destroying the transplanted islets Each patient will have hisher blood sugar levels and insulin requirements monitored very closely after each transplant The patients will also have various tests to determine if their diabetic complications improve remain the same or become worse The patients will be asked to record any episodes of hypoglycemia or low blood sugars while participating in this study Emory will examine whether or not there is a decrease in how often the episodes occur Patients will also undergo regular eye exams to document retinal changes or improvements that may occur after transplant At this time it is not known whether islet transplantation slows or stops the progression of common diabetic complications More experience and research is needed before this can be determined One focus of our research will be to study diabetic complications in patients who receive islet transplants
The major goal of the Emory Islet Transplant Program is for patients participating in this study to be free of the need for insulin injections after 2 islet transplants Because many advances have been made in islet transplantation the transplant team at Emory would like to participate in this promising treatment of type 1 diabetes and most importantly help those who suffer from this disease become free from daily insulin injections and avoid the devastating complications that happen as a result of diabetes
More than 1 million North Americans have type 1 diabetes Each year approximately 30000 new cases of type 1 diabetes are diagnosed in the United States Type 1 diabetes destroys islets a cluster of cells within the pancreas that produce insulin Insulin is a hormone with many effects However the most important effect of insulin is to control the level of sugar in the blood People with Type 1 diabetes no longer produce insulin and must take insulin injections to live Despite steady improvements in the management of this disease its victims remain at increased risk for stroke heart attack kidney failure amputation blindness nerve damage and premature death The life expectancy of a teenager is reduced by thirty years from the time of onset of the disease Unfortunately many type 1 diabetics cannot control their blood sugars in spite of very careful monitoring and the frequent injection of insulin This group of patients is considered to have labile or brittle diabetes These brittle diabetics can often have wide swings in their blood sugar levels that can be life threatening Hypoglycemia or low blood sugars occurs when too much insulin is in the bloodstream When this occurs it is vital that patients eat or drink something right away that will increase their blood sugars Many diabetics lose the ability to recognize when their blood sugars are getting dangerously low These episodes of hypoglycemia can lead to coma and possibly death if not recognized and treated right away Patients can also experience extreme increases in blood sugars or hyperglycemia as a result of emotional or physical stress Hyperglycemia can result in dehydration confusion and a condition called ketoacidosis which can lead to death When this happens insulin must be given as soon as possible
Islet transplantation can restore the bodys ability to make insulin and in turn restore normal blood sugar levels
Since the 1960s doctors and scientists have attempted to replace this islet function by performing whole organ pancreas transplantation While the results of pancreas transplantation have improved dramatically in recent years this approach has largely been limited to patients with kidney disease who have also needed a kidney transplant This is because of the risks associated with the surgical procedure and the immunosuppressive drugs required to prevent rejection or the destruction of the transplanted pancreas by the bodys immune system Transplantation of a whole pancreas requires a major operation that is done through an incision in the abdomen The patient must be under general anesthesia or asleep for the entire procedure Recent clinical experience suggests that islet transplantation may be a useful approach to correct diabetes in humans
Islet transplantation offers a direct approach to the treatment of type 1 diabetes A large number of experimental studies carried out in many laboratories over the last decade have documented the beneficial effects of islet transplants in experimental animals These experiments have confirmed both the efficiency and safety of islet transplantation
The inability to isolate enough islets from a single pancreas has been one obstacle to successful islet transplantation A certain number of islets must be isolated or separated from a single pancreas in order to use them for transplant If this minimum number of islets is not obtained then the islets do not effectively reverse diabetes Progress in isolating the islets from a human pancreas has been dramatic in the last several years Advances in equipment and technology have lead to increases in the number of islets that can be isolated from a single pancreas
After successful isolation the islets can be injected through a catheter into the patients liver during a thirty-minute procedure A group of doctors at the University of Alberta in Edmonton Canada has had promising results in human islet transplantation Normal sugar levels have been documented after human islet transplants Also recent improvements in immunosuppressive drug treatments have resulted in sustained insulin-independence in selected type 1 diabetic patients The traditional method of transplant immunosuppression includes using some form of a steroid drug Steroids have been found to injure or kill the islets after transplant The doctors in Edmonton Canada established an immunosuppression formula that does not use steroids The objective of the study here at Emory University is to reproduce the successful results of human islet transplantation that have been achieved by the doctors at the University of Alberta using steroid free immunosuppression
The Emory Islet Transplant Program will enroll ten patients ages 18 to 65 in the study Each of the ten patients will receive at least 2 islet transplants from 2 different organ donors A third transplant may be required based on the patients insulin requirements after the 1st two transplants Each patient will be placed on immunosuppressive drugs to prevent the body from rejecting or destroying the transplanted islets Each patient will have hisher blood sugar levels and insulin requirements monitored very closely after each transplant The patients will also have various tests to determine if their diabetic complications improve remain the same or become worse The patients will be asked to record any episodes of hypoglycemia or low blood sugars while participating in this study Emory will examine whether or not there is a decrease in how often the episodes occur Patients will also undergo regular eye exams to document retinal changes or improvements that may occur after transplant At this time it is not known whether islet transplantation slows or stops the progression of common diabetic complications More experience and research is needed before this can be determined One focus of our research will be to study diabetic complications in patients who receive islet transplants
The major goal of the Emory Islet Transplant Program is for patients participating in this study to be free of the need for insulin injections after 2 islet transplants Because many advances have been made in islet transplantation the transplant team at Emory would like to participate in this promising treatment of type 1 diabetes and most importantly help those who suffer from this disease become free from daily insulin injections and avoid the devastating complications that happen as a result of diabetes
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 |
|---|---|---|---|
| 10402 | OTHER | Other | None |