Islet After Kidney Transplantation (IAK) in Patients With Type 1 Diabetes

Diabetes Mellitus Clinical Trial

Official title: Islet After Kidney Transplantation (IAK) in Patients With Type 1 Diabetes Using a Sirolimus/Tacrolimus/MMF-Based Immunosuppressive Regimen

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety of islet transplantation in patients with type 1 diabetes who have had a successful kidney transplant and have been maintained for at least three months on anti-rejection medications consisting of any combination of sirolimus, tacrolimus, MMF or prednisone (5 mg/day or less). Another purpose is to determine the effectiveness of an islet transplant in inducing insulin independence and whether or not an islet transplant improves quality of life for kidney transplants patients with type 1 diabetes.

Clinical Trial Description

Insulin is a hormone that helps the body use sugar and keeps blood sugar levels normal. Special cells in the human body, called beta cells, make insulin. Beta cells are found inside small groups of cells called "islets." Islets are found scattered in the pancreas gland. Type 1 diabetes is caused by damage to these insulin-making cells. Type 1 diabetic patients need insulin shots because their body does not make enough insulin. Even with insulin shots, many diabetic patients develop damage to the heart, blood vessels, nerves, eyes and kidneys. Research studies suggest that these problems are caused by blood sugar levels being too high.

Another way to treat diabetes is by giving the patient a pancreas transplant. The pancreas transplant gives the patient new insulin-making cells. If the pancreas transplant works, the patient does not need insulin shots. Pancreas transplantation is considered major surgery, and things can go wrong after surgery. Transplantation of just the islets, and not the rest of the pancreas, can be done without a major surgery. Research doctors have been studying islet transplantation to determine whether subjects who undergo the procedure can get off insulin shots, without the dangers of a major surgery.

In 2000, a group of research doctors in Edmonton, Canada reported that 3 out of 4 research subjects given islet transplants from brain-dead donors did not need insulin shots for approximately 2 years after transplantation. The research doctors from Edmonton have also reported that most islet transplant recipients in their study start to need insulin shots again with longer follow-up. So far, only about 1 out of 10 of the research subjects in the original Edmonton trial remain off of insulin 5 years after their transplant. The reasons that islet transplants stop working well enough and the recipients need to start insulin again are not known at this time. As with any type of transplant, all of the research subjects receiving islets from donors needed medicine to stop their bodies from rejecting the transplants. This study uses a few additional medications/vitamins that were not included in the Edmonton study that may improve the long-term outcome of islet transplantation. Some research studies suggest that for subjects with type 1 diabetes, an islet transplant may also help the kidney transplant work better and last longer.

This study is being performed to confirm that islet after kidney transplantation (IAK) is a safe and effective procedure for kidney transplant patients with type 1 diabetes who are on any combination of sirolimus, tacrolimus, MMF or prednisone (5 mg per day or less) anti-rejection medications for the care of their kidney transplant. Subjects will be followed closely for two years after islet transplant to monitor blood sugar control, the health of the kidney transplant, and changes in quality of life. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

• NCT number: NCT00708604
• Study type: Interventional
• Source: City of Hope Medical Center
• Status: Completed
• Phase: Phase 1
• Start date: August 2005
• Completion date: June 2014