The effects of rosuvastatin therapy on glucose metabolism in non-diabetic renal transplant recipients with a focus on insulin sensitivity and pancreatic beta islet cell function - Statins, renal transplantation and glucose metabolism
- Conditions
- ew-onset diabetes after transplantationMedDRA version: 8.1 Level: LLT Classification code 10063634 Term: Post transplant diabetes mellitus
- Registration Number
- EUCTR2005-002777-68-GB
- Lead Sponsor
- Cardiff and Vale NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method