With improvements in patient and graft survival, increasing attention has been placed on complications that contribute to long-term patient morbidity and mortality. New-onset diabetes after transplantation (NODAT) is a common complication of solid-organ transplantation, and is a strong predictor of graft failure and cardiovascular mortality in the transplant population. Risk factors for NODAT in transplant recipients are similar to those in non-transplant patients, but transplant-specific risk factors such as hepatitis C (HCV) infection, corticosteroids and calcineurin inhibitors play a dominant role in NODAT pathogenesis. The predominant factor for causing NODAT by corticosteroids seems to be the aggravation of insulin resistance; however several studies have displayed deleterious effects on insulin secretion and β-cells. Thus, adjusting the immunosuppressant regimen to improve glucose tolerance must be measured and defined from long term perspective. As recipients of organ transplants survive longer, the complications of NODAT have assumed greater importance; therefore, we designed a prospective study to compare the safety and efficacy of early versus late withdrawal of corticosteroids after liver transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
tacrolimus (low dose, trough level of 5-12ng/ml)+Mycophenolate mofetil(500-1500mg/day\*, bid)+ Basiliximab + corticosteroids 500mg to 5mg or above (2 weeks)
tacrolimus (low dose, trough level of 5-12ng/ml)+Mycophenolate mofetil(500-1000mg/day\*, bid)+ Basiliximab + corticosteroids 500mg to 5mg or above (3 month±2weeks)
Daegu Catholic University Medical Center
Daegu, South Korea
NOT_YET_RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGNational Cancer Center
Seoul, South Korea
NOT_YET_RECRUITINGSeoul National University
Seoul, South Korea
NOT_YET_RECRUITINGAjou University Hospital
Suwon, South Korea
NOT_YET_RECRUITINGTo evaluate incidence of NODAT in patients of two arms
NODAT will be defined as consecutively FPG ≥126mg/dl in two different days or PPG 2hr ≥200mg/dl Ref. Steroid Withdrawal in Adult Liver Transplantation: Occurrence at a Single Center. Transplantation Proceedings, 2010; 42: 4132-4136) 1. Incidence of NODAT in ref. : (9.9%) 2. 95% Confidence Interval(CI): (6%) Considering 10% drop-out rate, 76 patients will be enrolled in one arm. Totally, 152 will be enrolled.
Time frame: for 1 year
To evaluate incidence rate of first acute rejection
Time frame: for 1 year
To evaluate time to first acute rejection
Time frame: for 1 year
To evaluate proportion of patients experiencing treatment failure
Time frame: for 1 year
To evaluate graft survival rates
Time frame: for 1 year
To evaluate patient overall survial, OS
Time frame: for 1 year
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