Clinical Trial: New-onset Diabetes and Left Ventricular Hypertrophy in Renal Transplantation

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: New- Onset Diabetes and Glucose Regulation Are Significant Determinants of Left Ventricular Hypertrophy in Renal Transplant Recipients

Brief Summary: New-onset diabetes (NODAT) after solid organ transplantation is an important clinical challenge associated to increased risk of cardiovascular (CV) events. In end-stage renal disease (ESRD) patients, the impact of arterial stiffness on all-cause and CV mortality has been clearly documented. Arterial stiffness has a pivotal role in the genesis of high blood pressure (SBP), increased left ventricular hypertrophy (LVH), and consequently CV mortality. Both LVH and arterial stiffness are independent determinants of CV disease in patients with ESRD. The aim of this study is to evaluate the relationship between post-transplant new-onset diabetes and arterial stiffness and left ventricular mass index (LVMI) in kidney transplant recipients.

Detailed Summary:

All patients' data were recorded from clinical charts. Visits in out patient clinic were organized as follows: three visits per week during the first 2 weeks; two visits per week until day 60; weekly visits until day 120; monthly visits during the first year; one visit every other month during the second year; and four visits per year thereafter until death or end-stage renal disease (i.e. dialysis or retransplantation). The following parameters were collected; 1) age, 2) gender, 3) posttransplantation duration, 4) pretransplant hemodialysis duration, 4) acute rejection episodes, 5) use of statins, ace inhibitor (ACE) or angiotensin receptor blocker (ARB), 6) immunosuppressive treatment (mycophenolate, cyclosporine, tacrolimus, and sirolimus use), 7) pretransplant lipid profile (values in the last month before transplantation), 8) posttransplant lipid profile (mean value), 9) FPG and HbA1c levels (mean value), 10) office blood pressure measurements, 11) hemoglobin, calcium, phosphorus, albumine and parathyroid hormone levels, 12) creatinine and estimated GFR (MDRD equation) and, 13) cytomegalovirus (CMV) infection history. Mean values were arithmetic means of each parameter that were collected from patient charts at 3 monthly basis after the first posttransplant 6 months while other parameters (12-16) were collected as single values at study inclusion.

All patients were under 5 mg prednisolone treatment within the immuno suppressive regimen. Maintenance immunosuppressive treatment included prednisone with a gradual tapering and mycophenolate mofetil or sodium associated with cyclosporine, tacrolimus or sirolimus in most patients. Target through levels at 3 months were 150-250 ng/ml for cyclosporine and 8-12 ng/ml for tacrolimus and sirolimus. Anti-diabetic treatment modalities (diet and lifestyle changes, oral anti-diabetic drugs or insulin) were also recorded for patient
Sponsor: Baskent University

Current Primary Outcome: Left ventricular hypertrophy [ Time Frame: 3 years follow-up after transplantation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Baskent University

Dates:
Date Received: October 30, 2013
Date Started: March 2012
Date Completion:
Last Updated: November 6, 2013
Last Verified: November 2013