Tacrolimus And Glucose Metabolism In Renal Transplantation (v. 1.1)
Research type
Research Study
Full title
A Single Centre Physiological Study of Glucose Metabolism Before and After Tacrolimus Withdrawal For Deteriorating Kidney Function In Renal Transplant Recipients
IRAS ID
41400
Contact name
Keshwar Baboolal
Contact email
Sponsor organisation
Cardiff And Vale University Health Board
Eudract number
2010-022075-66
ISRCTN Number
0000000000000
Clinicaltrials.gov Identifier
0000000000000
Research summary
Calcineurin inhibitors (CNIs) are powerful antirejection drugs used in kidney transplantation. The drawback to these medications is that they are toxic to kidneys. The availability of other powerful antirejection drugs has allowed the development of new protocols to minimise the exposure to CNIs. CNIs are also associated with the development of new onset diabetes after transplantation (NODAT) which is increasingly being recognised as a serious complication of transplantation as it can adversely affect the survival of the transplant recipient, kidney survival and the patient??s quality of life.CNIs such as tacrolimus have been shown to be toxic to pancreatic beta islet cells in animal studies. Studies have shown kidney transplant patients treated with CNIs have lower insulin secretion compared to healthy non transplanted subjects. Longitudinal studies have demonstrated a progressive decline in beta cell function in patients treated with tacrolimus. The impact of tacrolimus withdrawal on glucose metabolism is not well defined. The aim of the study is to examine changes in glucose and insulin characteristics in kidney transplant recipients in whom tacrolimus has been withdrawn for a clinical reason.The hypothesis is that the toxicity of CNIs on pancreatic beta cell function and insulin secretion is reversible, and that the withdrawal of CNIs will improve glucose tolerance status in kidney transplant recipients.This study will examine twenty to thirty non-diabetic kidney transplant recipients treated with Tacrolimus (a CNI) and Mycophenolate Mofetil or mycophenolic acid as antirejection treatment who have been transplanted at the University Hospital of Wales, Cardiff. The clinical team would have decided to withdraw tacrolimus in all potential participants in accordance with a current clinical protocol. Physiological glucose and insulin studies will take place at two time points ?? prior to withdrawal and 1 month following completely stopping tacrolimus. Results between the two time points will be compared.
REC name
Wales REC 3
REC reference
10/MRE09/37
Date of REC Opinion
17 Nov 2010
REC opinion
Favourable Opinion