Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome. (Merck-123)

November 12, 2023 updated by: Chu-Huang Chen, Baylor College of Medicine

Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 in Patients With Metabolic Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ezetimibe
Randomly chosen participants will receive ezetimibe 10mg daily for 3 months.
Drug: Ezetimibe
Ezetimibe 10mg daily for 3 months.
Other Names:
  • Zetia
Active Comparator: Simvastatin
Randomly chosen participants will receive Simvastatin 20mg daily for 3 months.
Drug: Simvastatin
Simvastatin 20mg daily for 3 months.
Other Names:
  • Zocor
Active Comparator: Vytorin
Randomly chosen participants will receive Vytorin 20/10mg daily for 3 months.
Drug: Vytorin
Vytorin 20/10mg daily for 3 months.
Other Names:
  • Ezetimibe/Simvastatin
Placebo Comparator: Placebo
Randomly chosen participants will receive Placebo tab 1 daily for 3 months.
Drug: Placebo
Placebo one tablet daily times 3 months.
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
L5 Concentration in Metabolic Syndrome Patients
Time Frame: 0 months, at the start
Patient's blood samples were collected before treatment. L5 were purified by ultracentrifugation then FPLC. Quantification analysis will indicate the L5 concentration (mg/dL) per group.
0 months, at the start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
L5 Concentration After Treatment of Ezetimibe, Simvastatin, or Vytorin in Metabolic Syndrome Patients
Time Frame: 3 months
Patient's blood samples were collected at the corresponding time point for L5 purification. L5 quantification and characterization were investigated with chemical analysis, proteomics and in-vitro cell signaling analysis. Final data analysis will determine total L5 concentration (mg/dL).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Chu-Huang Chen, M.D., Ph.D., Baylor College of Medicine
  • Study Director: Christie Ballantyne, M.D., Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (Estimated)

October 2, 2009

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20169
  • MK0653A (Other Grant/Funding Number: Merck)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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