Status:
COMPLETED
Effects of Selective Inhibition of Cholesterol Absorption With Ezetimibe on Intestinal Cholesterol Homeostasis in Dyslipidemic Men With Insulin-resistance - a Pilot Study
Lead Sponsor:
Laval University
Conditions:
Metabolic Syndrome X
Eligibility:
MALE
18-60 years
Phase:
PHASE3
Brief Summary
Ezetimibe has been shown to inhibit cholesterol absorption and several lines of evidence from in vitro systems and animal models suggest that this effect is associated with an increase in low-density ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01849068
Start Date
June 1 2013
End Date
February 1 2016
Last Update
April 12 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Laval University
Québec, Quebec, Canada, G1V 0A6