Conditions: Metabolic Syndrome
Keywords: Postprandial hypertriglyceridemia Metabolic syndrome Endothelial function Flow mediated dilatation EndoPAT Simvastatin Ezetimibe
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 100
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: First 6 weeks of Simvastatin 80mg, then 6 weeks of Simvastatin/Ezetimibe 10/10mg after 6 weeks of placebo washout arm 2: First 6 weeks of Simvastatin/Ezetimibe 10/10mg, then 6 weeks of Simvastatin 80mg after 6 weeks of placebo washout

Interventions: intervention 1: Simvastatin intervention 2: Simvastatin/Ezetimibe
Intervention descriptions: intervention 1: 6 weeks of treatment with simvastatin 80 mg intervention 2: 6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg combination

Protocol document: