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 |
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)
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