NCT01034540
Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
Sponsored by Provident Clinical Research
The objectives of this study are to assess the effects of 4 g/d prescription omega-3 acid ethyl esters (POM3), compared with a placebo, on indices of insulin sensitivity and secretion, as well as aspects of the fasting and postprandial lipid and lipoprotein profiles, in subjects with hypertriglyceridemia.
Inclusion Criteria: * Men and postmenopausal women, ages 18-79 years. * Fasting, triglyceride (TG) level in the borderline high to high range. * Fasting, low density lipoprotein cholesterol (LDL-C) below the very high range while on no lipid altering therapy or while taking stable-dose statin therapy * Provide written informed consent and authorization for protected health information Exclusion Criteria: * Use of any lipid-altering medications, which cannot be stopped, except stable dose statin therapy. * Use of any omega-3 fatty acid ethyl ester medications or dietary supplements with \>1.0 g/d of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or a combination of EPA and DHA * coronary heart disease (CHD) or a CHD risk equivalent * Body mass index over 45 kg per square meter * Allergy or sensitivity to omega-3 fatty acids, corn or corn products (e.g., corn oil), D-alpha tocopherol (vitamin E) or any ingredients in the study drug * Certain muscle, liver, kidney, lung or gastrointestinal conditions * Poorly controlled hypertension * Certain medications * Active cancers treated within prior 2 years (except non-melanoma skin cancer)
Provident Clinical Research (now Biofortis)
Addison, Illinois, United States
Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.
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