Status:
COMPLETED
Effects of Ezetimibe on Postprandial Hyperlipidemia and Endothelial Function
Lead Sponsor:
UMC Utrecht
Conditions:
Metabolic Syndrome
Eligibility:
MALE
18-70 years
Phase:
PHASE4
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 ...
Detailed Description
In patients at high risk for future cardiovascular events, more intensive LDL cholesterol lowering with high doses statin therapy provides greater protection against death or major cardiovascular even...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00189085
Start Date
December 1 2004
End Date
July 1 2005
Last Update
June 10 2010
Active Locations (1)
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1
Department of Vascular Medicine UMC Utrecht
Utrecht, Utrecht, Netherlands, 3584 CX