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

NCT ID: NCT01034540

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-02-28

Brief 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.

Detailed Description

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 POM3 for the first 6 week phase followed by the study product they did not receive during the first phase (POM3 or placebo) for the second 6 weeks. There will be a 2-week washout period between treatment phases.

Conditions

Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

POM3

POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment

Group Type: EXPERIMENTAL

POM3

Intervention Type: DRUG

4 g/day

Placebo

Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matching placebo capsule, 4 g/day

Interventions

POM3

4 g/day

Intervention Type: DRUG

Placebo

matching placebo capsule, 4 g/day

Intervention Type: DRUG

Other Intervention Names

Lovaza; prescription omega-3 acid ethyl esters

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Provident Clinical Research

OTHER

Sponsor Role: lead

Responsible Party

Kevin C. Maki, PhD

Study Director/Chief Science Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin C. Maki, PhD

Role: STUDY_DIRECTOR

Provident Clinical Research

Locations

Provident Clinical Research (now Biofortis)

Addison, Illinois, United States

Countries

United States

References

Maki KC, Lawless AL, Kelley KM, Dicklin MR, Schild AL, Rains TM. Prescription omega-3-acid ethyl esters reduce fasting and postprandial triglycerides and modestly reduce pancreatic beta-cell response in subjects with primary hypertriglyceridemia. Prostaglandins Leukot Essent Fatty Acids. 2011 Sep-Oct;85(3-4):143-8. doi: 10.1016/j.plefa.2011.06.005. Epub 2011 Jul 19.

Reference Type: RESULT

PMID: 21775113 (View on PubMed)

Other Identifiers

PRV-09009

Identifier Type: -

Identifier Source: org_study_id