New-onset diabetes after transplantation MedDRA version: 8.1 Level: LLT Classification code 10063634 Term: Post transplant diabetes mellitus
Conditions
Interventions
Trade Name: Crestor
Product Name: Crestor
Pharmaceutical Form: Capsule, hard
Other descriptive name: ROSUVASTATIN CALCIUM
Concentration
Sponsors
Cardiff and Vale NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Caucasian, non-diabetic renal transplant recipients, with stable allograft function under the care of the Nephrology and Transplant Directorate, University Hospital of Wales, Cardiff. Subjects can be 6 months to 10 years post-transplantation, at the time of randomisation. Primary immunosuppression: Tacrolimus Subjects should have a total cholesterol = 4.5mmol/l and/or LDL cholesterol = 2.5 mmol/l) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or current breast feeding 2. History of cardiovascular disease 3. Fasting cholesterol of > 8 mmol/l 4. Unstable allograft function 5. Diabetic subjects 6. Non-Caucasian patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to examine the effects of rosuvastatin therapy on markers of the glucose metabolism, blood pressure and lipid profile amongst non-diabetic renal transplant recipients. ;Secondary Objective: ;Primary end point(s): Change in disposition index (product of insulin sensitivity and acute insulin response to glucose) | — |
Countries
United Kingdom
Outcome results
None listed