A randomised, double blind, parallel-group study of the oxidative stress lowering effect of simvastatin and atorvastatin.
Phase 4
- Conditions
- arteriosclerosisAtherosclerosis1001108210003216
- Registration Number
- NL-OMON30464
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Patients in the age between 18 and 70 years, with diabetes mellitus type 2 and/or hypertension (RR > 140/90 mmHg) and/or obesity (BMI >25) and LDL > 2,5 mmol/l.
Exclusion Criteria
Stage 5 chronic kidney disease
Use of an ACE inhibitor
Statin use in three months prior to inclusion
LDL cholesterol < 2,5 mmol/L
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Considering that there is no gold standard to measure effect on oxidative<br /><br>stress, established parameters of oxidative stress such as oxidized LDL,<br /><br>malondealdehyde and isoprostane will be measured in plasma and urine. All<br /><br>parameters of oxidative stress before and during treatment with one of both<br /><br>statins will be compared to determine whether atorvastatin causes a stronger<br /><br>and quicker reduction of oxidative stress than simvastatin. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Niet van toepassing</p><br>