Islet After Kidney Transplantation (IAK) in Patients With Type 1 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): Islet Transplantation; Islet cell transplantation
Intervention type(s): Procedure; Biological
Intervention description(s): Islet Transplantation; Islet cell transplantation will occur through the portal vein.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Kidney Transplantation; Islet Transplantation; Sirolimus/Tacrolimus/MMF-based Immunosuppressive Regimen