Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome LDL subfraction L5 The reduction of LDL in patients with Metabolic Syndrome The prevalence of L5 in patients with Metabolic Syndrome The reduction of L5 in patients with Metabolic Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
The purpose of this study is:

* To identify the common factor for L5 prevalence in patients with Metabolic Syndrome.
* To determine whether Ezetimibe, Simvastatin, and Vytorin can correct the L5- promoting factor and reduce L5 in Metabolic Syndrome patients.

Detailed description:
Epidemiological evidence indicates that metabolic syndrome (MS) is a strong predisposing condition for atherosclerosis. Elevation of plasma low-density lipoprotein (LDL) cholesterol(LDL-C) concentration is the most important risk factor for atherosclerosis; however, LDL-C elevation is not a criterion for metabolic syndrome, raising the question of LDL's role in the syndrome's association with atherosclerosis. L5, a highly electronegative and mildly oxidized LDL subfraction that we recently isolated from hypercholesterolemic human plasma, may provide a key to answering this question. In cultured vascular endothelial cells (EC), L5 inhibits proliferation and induces apoptosis and monocyte-EC adhesion. In our preliminary studies, L5 could also be detected in patients with MS without elevated LDL-C. Because other LDL subfractions were harmless to EC, the presence of MS-L5 prompted us to hypothesize that the atherogenic role of LDL is not solely determined by plasma LDL-C concentration, but more importantly, by its composition. The proposed study is designed to test this hypothesis. The first question we will address is what lipid factor determines the prevalence of L5 in MS.

Subsequently, we will examine whether treatment with selected medicines can effectively reduce L5 in MS patients by correcting the factor favorable for L5 formation.

We are in the process of identifying the active components of L5 to fully characterize the atherogenic role of L5 in MS,. In the current proposal, we focus our interest on the efficacy of Ezetimibe, Simvastatin, and Vytorin in reducing L5 from the plasma of MS patients.

Arms:
arm 1: Randomly chosen participants will receive ezetimibe 10mg daily for 3 months. arm 2: Randomly chosen participants will receive Simvastatin 20mg daily for 3 months. arm 3: Randomly chosen participants will receive Vytorin 20/10mg daily for 3 months. arm 4: Randomly chosen participants will receive Placebo tab 1 daily for 3 months.

Interventions: intervention 1: Simvastatin intervention 2: Vytorin intervention 3: Placebo intervention 4: Ezetimibe
Intervention descriptions: intervention 1: Simvastatin 20mg daily for 3 months. intervention 2: Vytorin 20/10mg daily for 3 months. intervention 3: Placebo one tablet daily times 3 months. intervention 4: Ezetimibe 10mg daily for 3 months.

Protocol document: