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Effects of Ezetimibe on Postprandial Hyperlipidemia and Endothelial Function

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ClinicalTrials.gov Identifier: NCT00189085
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 10, 2010
Information provided by:

Study Description
Brief Summary:
In the present study the investigators are researching the effects of the cholesterol absorption inhibitor ezetimibe on postprandial lipemia and postprandial endothelial function in patients with the metabolic syndrome. The lipid-lowering effect of high-dose statin monotherapy on fasting lipids is equal to the combination therapy of low-dose statin and ezetimibe.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: simvastatin and ezetimibe Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effects of Ezetimibe on Postprandial Hyperlipidemia and Endothelial Dysfunction in Patients With the Metabolic Syndrome.
Study Start Date : December 2004
Estimated Study Completion Date : July 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Postprandial lipemia [ Time Frame: 0, 1, 2 and 4 hours after eating ]
  2. Postprandial endothelial function [ Time Frame: 0 and 4 hours after the meal ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and female (postmenopausal) patients, 18-70 years of age
  2. Diagnosis of the metabolic syndrome according to ATP III criteria(4), including 3 or more of the following metabolic abnormalities:

    • abdominal obesity (waist circumference > 102 cm in men and > 88 cm in women)
    • elevated blood pressure (³ 130 mmHg systolic or ³ 85 mmHg diastolic)
    • hypertriglyceridemia (serum triglycerides ³ 1.70 mmol/L
    • low high-density lipoprotein (HDL) cholesterol (serum HDL-cholesterol <1.04 mmol/L in men and < 1.29 mmol/L in women)
    • high fasting glucose (fasting serum glucose ³ 6.1 mmol/L)
  3. Written informed consent

Exclusion Criteria:

  1. Smoking
  2. Thyroid disease (TSH > 5 mU/L with clinical symptoms of hypothyroidism)
  3. Hepatic disease (ASAT or ALAT > 2 times the upper limit of normal)
  4. Renal disease (serum creatinine > 1.7 times the upper limit of normal).
  5. A history of coronary heart disease, cerebrovascular disease or peripheral arterial disease.
  6. Use of lipid lowering therapy
  7. Systolic blood pressure ≥ 180 mmHg and /or diastolic blood pressure ≥ 110 mmHg
  8. BMI > 35
  9. HbA1c > 6.5%
  10. Triglycerides > 8.0 mmol/L
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189085

Department of Vascular Medicine UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Principal Investigator: Frank LJ Visseren, MD PhD UMC Utrecht
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00189085     History of Changes
Other Study ID Numbers: EZET
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 10, 2010
Last Verified: August 2004

Keywords provided by UMC Utrecht:
Metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors