Lovaza Mechanisms of Action

Phase 4

• Conditions: Moderate Hypertriglyceridemia.

• Registration Number: NCT01301794
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

High levels of triglycerides is a common abnormality found in patients with diabetes and also cardiovascular disease, and may contribute to the risk for both. Omega 3 fatty acids, as found enriched in fish and also in the commercial agent called Lovaza lower triglyceride levels. Prior work from the investigators group demonstrated that an enzyme responsible for the break down of triglycerides - lipoprotein lipase - generates molecules that can activate a specific nuclear receptor known as PPAR-alpha. This study investigates the hypothesis that taking Lovaza shifts the specific fatty acid content of triglyceride containing lipoproteins and increases the ability of those lipoproteins to activate PPAR-alpha.

Detailed Description

This study will investigate changes in lipid and other metabolic parameters as well as the ability of isolated lipoproteins to activate PPARs in the presence or absence of lipoprotein lipase in a cohort of normal healthy individuals with modest hypertriglyceridemia before and after a course of Lovaza.

Study Timeline

• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Study Start: 2012-08
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-21
• Last Update Posted: 2013-02-25
• Primary Completion: 2013-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Otherwise healthy 21 to 65 year old men and women
• Triglycerides >150 < 500 mg/dL

Exclusion Criteria

• Other lipid lowering medication including fish oil
• Major illnesses
• Diabetes
• Cardiovascular disease
• Abnormalities uncovered on screening blood work including undiagnosed diabetes, abnormal liver function tests, triglycerides > 500 mg/dL
• Indication for immediate statin therapy
• Pregnancy
• Contraindication for fish oil use or muscle biopsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in lipoprotein metabolite content and their ability to activate PPAR-alpha in an established cell culture system.	3 months	Enrolled subjects will serve as their own controls and will be studied at baseline and after 3 months of Lovaza. The primary endpoint will test changes in lipoproteins as a function of their content and ability to activate PPAR-alpha in standard transfected cell culture systems.

Secondary Outcome Measures

Name	Time	Method
Changes in plasma markers for atherosclerosis	3 months	Subjects will also be studied before and after Lovaza for changes in lipid profile and c- reactive protein
Change in plasma markers of diabetes	3 months	Plasma markers of diabetes will be measure before and after Lovaza treatment for 3 months, specifically glucose and A1C levels
Changes in plasma markers of liver function	3 months	Plasma levels of liver function tests, specifically ALT and AST before and after 3 months of Lovaza.; This is not a safety issue since elevated triglycerides can cause increased liver function tests and fish oil (like Lovaza) can lower triglyceride levels and hence ALT and AST levels.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States