Improving Secretion of Insulin in New Onset Diabetes After Renal Transplantation (ISINODAT)
New Onset Diabetes Mellitus After Renal Transplantation
About this trial
This is an interventional treatment trial for New Onset Diabetes Mellitus After Renal Transplantation focused on measuring NODAT, kidney transplantation, beta cell function, insulin, Tacrolimus, Cyclosporine A
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed NODAT defined by pathologic OGTT (2h, 75mg glucose):
glucose ≥ 200mg/dl
- Defect in insulin secretion as judged by OGTT and HOMA B
- Renal transplantation (deceased or living donor) and treatment with the standard immunosuppression at our center, consisting of tacrolimus, mycophenolate mofetil, prednisone triple therapy without any induction
- stable graft function for more than 3 months post transplant
- informed consent of the patient
Exclusion Criteria:
- patients with prior history of type 1 or type 2 diabetes
- time since transplantation more than 20 years
- allergy against long-acting insulin or cyclosporine A
- body mass index (BMI) > 35
- pregnancy
Sites / Locations
- Medical University of Vienna/General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cyclosporine A
Tacrolimus
Patients in this arm will be switched from immunosuppressive therapy with Tacrolimus to Cyclosporine A. Furthermore, patients in this arm will commence insulin treatment with NPH-insulin to reach normoglycemia. After the achievement of normoglycemia the insulin treatment will be continued for three more weeks and than terminated.
Patients in this arm will remain on their immunosuppressive therapy with Tacrolimus. Furthermore, patients in this arm will commence insulin treatment with NPH-insulin to reach normoglycemia. After the achievement of normoglycemia the insulin treatment will be continued for three more weeks and than terminated.