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Effects of Ezetimibe on Postprandial Hyperlipidemia and Endothelial Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189085
First Posted: September 16, 2005
Last Update Posted: June 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
UMC Utrecht
  Purpose
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 Intervention Phase
Metabolic Syndrome Drug: simvastatin and ezetimibe Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

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

Estimated Enrollment: 20
Study Start Date: December 2004
Estimated Study Completion Date: July 2005
  Show Detailed Description

  Eligibility

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
Criteria

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


Locations
Netherlands
Department of Vascular Medicine UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Investigators
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 Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: June 10, 2010
Last Verified: August 2004

Keywords provided by UMC Utrecht:
Metabolic syndrome

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