Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Provident Clinical Research
• Collaborator: GlaxoSmithKline

Criteria

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)