NCT00189085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

June 10, 2010

Status Verified

August 1, 2004

First QC Date

September 12, 2005

Last Update Submit

June 9, 2010

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome

Outcome Measures

Primary Outcomes (2)

  • Postprandial lipemia

    0, 1, 2 and 4 hours after eating

  • Postprandial endothelial function

    0 and 4 hours after the meal

Interventions

simvastatin and ezetimibeDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Vascular Medicine UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (3)

  • 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. doi: 10.1093/eurheartj/ehn431. Epub 2008 Sep 28.

    PMID: 18824462DERIVED

  • 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. doi: 10.1097/FJC.0b013e31817ffe76.

    PMID: 18670365DERIVED

  • 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. doi: 10.1111/j.1365-2265.2008.03250.x. Epub 2008 Apr 3.

    PMID: 18394022DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Ezetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SimvastatinLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsEzetimibeAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Frank LJ Visseren, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

December 1, 2004

Study Completion

July 1, 2005

Last Updated

June 10, 2010

Record last verified: 2004-08

Locations

NL(1)