Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.
|ClinicalTrials.gov Identifier: NCT00988364|
Recruitment Status : Unknown
Verified October 2009 by Baylor College of Medicine.
Recruitment status was: Not yet recruiting
First Posted : October 2, 2009
Last Update Posted : October 6, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Drug: Simvastatin Drug: Vytorin Drug: Placebo Drug: Ezetimibe||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 in Patients With Metabolic Syndrome|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||April 2010|
|Estimated Study Completion Date :||July 2010|
Active Comparator: Ezetimibe
Randomly chosen participants will receive ezetimibe 10mg daily for 3 months.
Ezetimibe 10mg daily for 3 months.
Active Comparator: Simvastatin
Randomly chosen participants will receive Simvastatin 20mg daily for 3 months.
Simvastatin 20mg daily for 3 months.
Active Comparator: Vytorin
Randomly chosen participants will receive Vytorin 20/10mg daily for 3 months.
Vytorin 20/10mg daily for 3 months.
Placebo Comparator: Placebo
Randomly chosen participants will receive Placebo tab 1 daily for 3 months.
Placebo one tablet daily times 3 months.
- To identify the common factor for L5 prevalence in Metabolic Syndrome patients. [ Time Frame: 3 months ]
- To determine whether Ezetimibe, Simvastatin, and Vytorin can correct the L5- promoting factor and reduce L5 in Metabolic Syndrome. [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988364
|Contact: Sarah L Liscum, MPHfirstname.lastname@example.org|
|United States, Texas|
|Baylor College of Medicine||Active, not recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Chu-Huang Chen, M.D., Ph.D.||Baylor College of Medicine|
|Study Director:||Christie Ballantyne, M.D.||Baylor College of Medicine|