Effects of Ezetimibe on Postprandial Hyperlipidemia and Endothelial Function - Full Text View

Sponsor:	UMC Utrecht
Information provided by:	UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00189085

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind 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:

MedlinePlus related topics: Metabolic Syndrome Statins

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:

Postprandial lipemia [ Time Frame: 0, 1, 2 and 4 hours after eating ] [ Designated as safety issue: No ]
Postprandial endothelial function [ Time Frame: 0 and 4 hours after the meal ] [ Designated as safety issue: No ]

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

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Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female (postmenopausal) patients, 18-70 years of age
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)
Written informed consent

Exclusion Criteria:

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

Contacts and Locations

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

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Westerweel PE, Visseren FL, Hajer GR, Olijhoek JK, Hoefer IE, de Bree P, Rafii S, Doevendans PA, Verhaar MC. Endothelial progenitor cell levels in obese men with the metabolic syndrome and the effect of simvastatin monotherapy vs. simvastatin/ezetimibe combination therapy. Eur Heart J. 2008 Nov;29(22):2808-17. Epub 2008 Sep 28.

Olijhoek JK, Hajer GR, van der Graaf Y, Dallinga-Thie GM, Visseren FL. The effects of low-dose simvastatin and ezetimibe compared to high-dose simvastatin alone on post-fat load endothelial function in patients with metabolic syndrome: a randomized double-blind crossover trial. J Cardiovasc Pharmacol. 2008 Aug;52(2):145-50.

Hajer GR, Dallinga-Thie GM, van Vark-van der Zee LC, Olijhoek JK, Visseren FL. Lipid-lowering therapy does not affect the postprandial drop in high density lipoprotein-cholesterol (HDL-c) plasma levels in obese men with metabolic syndrome: a randomized double blind crossover trial. Clin Endocrinol (Oxf). 2008 Dec;69(6):870-7. Epub 2008 Apr 3.

ClinicalTrials.gov Identifier:	NCT00189085 History of Changes
Other Study ID Numbers:	EZET
Study First Received:	September 12, 2005
Last Updated:	June 9, 2010
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:

Metabolic syndrome

Additional relevant MeSH terms:

Hyperlipidemias
Metabolic Syndrome X
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Simvastatin
Ezetimibe

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012