Immunosuppression Impact on the Metabolic Control of First Kidney Transplant Recipients With Pre-Existing Type 2 Diabetes (DM)
Recruitment status was Recruiting
Protocol Title: Randomized open label study comparing the metabolic control of first Kidney Transplant recipients with Pre-Existing Type 2 Diabetes Mellitus (DM) receiving either Prograf or Neoral as part of a Thymoglobulin induction, prednisone free and blood monitored Cellcept immunosuppressive drug regimen.
PURPOSE This is a single center medical research study to analyze post-transplant kidney recipients with pre-existing (prior to transplantation) type 2 diabetes managed according to the recommended American Diabetes Association (ADA) guidelines. Prograf (Tacrolimus) and Neoral (Cyclosporin) are the two main medications to prevent rejection after transplantation. However, they may contribute to poorer diabetes control. The purpose of the study is to compare the effects of Prograf and Neoral on the control of Diabetes after kidney transplantation. In addition, all participants in this study will receive Thymoglobulin (anti-lymphocyte globulin) at the time of transplantation instead of long term prednisone (steroids). Prednisone can worsen diabetes.
Diabetes Mellitus, Type 2
Behavioral: Diabetes Education / Management
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Open Label Study Comparing the Metabolic Control of First Kidney Transplant Recipients With Pre-Existing Type 2 Diabetes (DM) Receiving Either Prograf or Neoral as Part of a Thymoglobulin Induction, Prednisone Free and Blood Monitored Cellcept Immunosuppressive Drug Regimen.|
- Primary Endpoints:
- Maintenance of glucose metabolism within the ADA criteria without usage of insulin at 3, 6 and 12 months after kidney transplantation.
- Number of class of oral agents required to maintain glycemic control within the ADA criteria at 3, 6 and 12 months after kidney transplantation
- Insulin requirements.
- Markers of glucose tolerance and insulin secretion (OGTT, C-peptide, insulin levels, Glycosylated hemoglobin, fructosamine) at 3, 6 and 12 months after kidney transplantation.
- Lipid metabolism, change in BMI and waist measurements at 3, 6 and 12 months after kidney transplantation.
- Patient and graft survival at one year post transplantation)
- Incidence of biopsy proven acute rejection at 6 month post transplantation
- Kidney function at one year (creatinine clearance and proteinuria)
- Infection rate
- Re-admission related to diabetes complication
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||October 2005|
|Contact: Stephan Busque, MDfirstname.lastname@example.org|
|Contact: Anna Simos, MPH, CDEemail@example.com|
|United States, California|
|Stanford university Hospital and Clinics||Recruiting|
|Stanford, California, United States, 94305|
|Principal Investigator: Stephan Busque, MD|
|Sub-Investigator: Andrew Bonham, MD|
|Sub-Investigator: Richard Lafayette, MD|
|Sub-Investigator: Tracey McLaughlin, MD|
|Sub-Investigator: Maria Millan, MD|
|Sub-Investigator: John Scandling, MD|
|Sub-Investigator: Jane Tan, M.D., PhD|
|Principal Investigator:||Stephan Busque, MD||Stanford University|