Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Baylor College of Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00988364
First received: October 1, 2009
Last updated: October 5, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Metabolic Syndrome
Drug: Simvastatin
Drug: Vytorin
Drug: Placebo
Drug: Ezetimibe
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 in Patients With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • To identify the common factor for L5 prevalence in Metabolic Syndrome patients. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether Ezetimibe, Simvastatin, and Vytorin can correct the L5- promoting factor and reduce L5 in Metabolic Syndrome. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: October 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ezetimibe
Randomly chosen participants will receive ezetimibe 10mg daily for 3 months.
Drug: Ezetimibe
Ezetimibe 10mg daily for 3 months.
Active Comparator: Simvastatin
Randomly chosen participants will receive Simvastatin 20mg daily for 3 months.
Drug: Simvastatin
Simvastatin 20mg daily for 3 months.
Active Comparator: Vytorin
Randomly chosen participants will receive Vytorin 20/10mg daily for 3 months.
Drug: Vytorin
Vytorin 20/10mg daily for 3 months.
Placebo Comparator: Placebo
Randomly chosen participants will receive Placebo tab 1 daily for 3 months.
Drug: Placebo
Placebo one tablet daily times 3 months.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who meet 3 or more of the 5 criteria specified in the ATPIII guidelines will be recruited.
  • The 5 criteria are:

    1. abdominal obesity (men>40 inches, women >35 inches);
    2. TG> 150mg/dL;
    3. low HDL-C (men < 40mg/dL, women < 50 mg/dL);
    4. high blood pressure (>or=130/>or=85 mmHg);
    5. fasting glucose > or = 110mg/dL.
  • People with different ethnic backgrounds will be included.

Exclusion Criteria:

  • symptomatic coronary artery disease
  • peripheral vascular disease
  • cerebral ischemia (stroke)
  • smoking
  • hypothyroidism
  • kidney diseases
  • consumption of antioxidation supplements/drugs or use of lipid-lowering drugs in the last 3 months
  • women who are pregnant, nursing, or planning to become pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988364

Contacts
Contact: Sarah L Liscum, MPH 713-798-6476 slliscum@bcm.tmc.edu

Locations
United States, Texas
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Chu-Huang Chen, M.D., Ph.D. Baylor College of Medicine
Study Director: Christie Ballantyne, M.D. Baylor College of Medicine
  More Information

Publications:
Chen CH, Pace PW, Karakoc ND, Lu J, Chen HH, Henry PD, Pownall HJ Foreyt JP, Ballantyne CM, Yang CY. Effective reduction of novel atherogenic LDL subfraction by atorvastatin in patients with hypercholesteremia. J AM Coll Cardiol. 2004:43(suppl A):486A (Abstract)
Libby P. Inflammation in atherosclerosis. Nature. 2002;420:868-874.

Responsible Party: Chu-Huang Chen, M.D., Ph.D., Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00988364     History of Changes
Other Study ID Numbers: Merck-123, MK0653A
Study First Received: October 1, 2009
Last Updated: October 5, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Metabolic Syndrome
LDL subfraction L5
The reduction of LDL Chol in patients with Metabolic Syndrome
The prevalence of L5 in patients with Metabolic Syndrome
The reduction of L5 subfraction in patients with Metabolic Syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Simvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014