Effects of Ezetimibe on Postprandial Hyperlipidemia and Endothelial Function

This study has been completed.
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00189085
First received: September 12, 2005
Last updated: June 9, 2010
Last verified: August 2004
  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
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:


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
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
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: 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):
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 July 20, 2014