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This study examined how the drug Ezetimibe, by selectively reducing cholesterol absorption, affects intestinal cholesterol balance, compared with placebo. It included men aged 18-60 with insulin resistance and dyslipidemia. The study was conducted in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Men aged between 18-60 years * Waist circumference \> 102 cm * HDL-cholesterol \< 1.1 mmol/L * Triglycerides \> 1.7 mmol/L * Fasting blood glucose \> 6.1 mmol/L * Normal blood pressure (\<130/85) Exclusion Criteria: * Women * Men \< 18 or \> 60 years * Smokers (\> 1 cigarette/day) * Body weight variation \> 10% during the last 6 months prior to the study baseline * Subjects with a previous history of cardiovascular disease * Subjects with type 2 diabetes * Subjects with a monogenic dyslipidemia * Subjects on hypertension medications or medications known to affect lipoprotein metabolism or the integrity of gastrointestinal mucosa * Subjects with endocrine or gastrointestinal disorders * History of alcohol or drug abuse within the past 2 years * Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.