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



Status:Completed
Conditions:High Cholesterol, Metabolic
Therapuetic Areas:Cardiology / Vascular Diseases, Pharmacology / Toxicology
Healthy:No
Age Range:18 - 79
Updated:10/19/2013
Start Date:March 2010
End Date:February 2011
Contact:Kevin C. Maki, PhD
Email:kmaki@providentcrc.com
Phone:630-858-4400

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A Double-blind, Randomized, Placebo-controlled, Crossover Trial to Assess the Effects of 4 g/d Prescription Omega-3 Acid Ethyl Esters on Indices of Glucose Homeostasis and Lipoprotein Lipids in Subjects With Hypertriglyceridemia


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.


This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2
(Week 0), subjects meeting all entry criteria will be randomized to one of two treatment
sequences: placebo or prescription omega-3 acid ethyl esters for the first 6 week phase
followed by the study product they did not receive during the first phase (prescription
omega-3 acid ethyl esters or placebo) for the second 6 weeks.

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 EPA,DHA, or a combination of EPA and DHA

- 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)
We found this trial at
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Addison, Illinois 60101
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Addison, IL
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