Efficacy of Islet after Kidney Transplantation  (CIT-06)

In general, to participate in this study, one must be 18-65 years of age, diagnosed with type 1 diabetes before age 40, be insulin dependent for more than 5 years, and have received a kidney transplant. There are more specific inclusion and exclusion criterion for participation in this study, which can be discussed with the study contact.

This study is one of seven studies being conducted by the Clinical Islet Transplant (CIT) Consortium, which is a network of clinical centers and a data coordinating center established in 2004 to conduct studies of islet transplantation in patients with type 1 diabetes.

Studies conducted by the CIT Consortium will focus on improving the safety and long-term success of methods for transplanting islets, the insulin-producing cells of the pancreas, in people whose own islets have been destroyed by the autoimmune process that characterizes type 1 diabetes.

The goals of the CIT studies are to:

• improve the isolation and viability of islets;
• reduce complications of the islet transplant procedure(e.g., bleeding and clotting in the blood vessels of the liver);
• reduce the side effects of immunosuppression;
• achieve good blood sugar control without hypoglycemia;
• follow the fate of islets after transplantation and determine why donor islets sometimes fail; and
• evaluate new ways to safely prevent immune rejection of donor tissues.

The goals of the CIT06 studies are to:

• test the hypothesis that successful isolated islet transplantation in patients with established kidney transplants leads to reduced risk of diabetes-related complications as assessed by improved metabolic control measured by serial HbA1c levels and/or reduced occurrence of hypoglycemic events compared with intensive insulin therapy (ITT).
• assess whether successful islet transplantation compared to ITT leads to improved quality of life, improved metabolic control and reduced cardiovascular, renal, and neurologic complications from diabetes.

Participants in this study will undergo an extensive screening process before being accepted for the first part of the study. The screening process will be a multi-faceted intensive medical evaluation. After the screening process is complete, participants who will be told if they qualify for the first part of the study and asked if they wish to participate. The first part of the study involves at least 4 months of intensive insulin therapy. After this period is over, participants who meet certain criteria will be invited to participate in the second part of the study.

During the second part of the study, participants are randomly assigned to two groups. One group will receive an islet transplant and the one group will continue with the intensive insulin therapy. Participants who are assigned to the islet transplant group will be listed for a transplant. Once a donor is found, the transplant will occur. The time from listing to transplant can be lengthy. Participants who are assigned to the intensive insulin therapy group will continue to receive care from the study physician.

The transplant procedure will require hospitalization. During this time, a participant will be given many medications to help the islets work. Additional testing will be done at specific time intervals after the transplant procedure. Additional islet transplants may be needed if specific results are not achieved.

If you agree to participate in this study, your involvement in the study will last for at least three years. The length of time you participate in this study and the number of visits you will be asked to attend will depend on whether you get an islet transplant or remain on standard medical care with insulin, how long you wait for a transplant (if you are to receive one), and how many islet transplants you receive.

You cannot participate in any other research studies in which treatments are given. However, it may be possible for you to participate in other kinds of studies that do not involve intervention.

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