The purpose of this study is to investigate whether low-dose simvastatin in combination with ezetimibe in comparison to high-dose simvastatin alone, has a beneficial effect on the function of the endothelium after an oral fat load in patients with metabolic syndrome.
Metabolic syndrome is defined as a group of cardiovascular risk factors and is mainly driven by the epidemic of obesity. High blood lipid levels after a meal may be an important risk factor for cardiovascular disease. In this study we will investigate whether simvastatin in combination with ezetimibe vs. simvastatin alone, has a beneficial effect on the lipid levels after a meal, but more importantly, whether we can measure a difference in function of the endothelium. In a small pilot study we already found that the combination had a beneficial effect in comparison with simvastatin alone. Now we want to solidify these findings in a larger study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
6 weeks of treatment with simvastatin 80 mg
6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg combination
Department of Vascular Medicine UMC Utrecht
Utrecht, Utrecht, Netherlands
Academic Medical Center
Amsterdam, Netherlands
Vascular Research Center Hoorn
Hoorn, Netherlands
Tweesteden Ziekenhuis
Waalwijk, Netherlands
Treatment Difference in (Postprandial-Fasting) FMD
A comparison of the postprandial minus fasting change in FMD under treatment with simvastatin 80 mg versus simvastatin 10/10 mg
Time frame: After 6 weeks of treatment
Postprandial Endopat Measurement
Time frame: after 6 weeks of treatment (crossover)
Preprandial Endothelial Function Measured by FMD
Time frame: after 6 weeks of treatment (crossover)
Preprandial Endopat Measurement
Time frame: after 6 weeks of treatment (crossover)
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Hospital Arnau de Vilanova
Lleida, Spain