Lovaza Mechanisms of Action
Recruitment status was: Recruiting
|Moderate Hypertriglyceridemia.||Dietary Supplement: Omega 3 fatty acid (Lovaza)||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Study of the Effects of Lovaza (Omega 3 Fatty Acids) On Lipoprotein Particles and Their Transcriptional Effects|
- Changes in lipoprotein metabolite content and their ability to activate PPAR-alpha in an established cell culture system. [ Time Frame: 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.
- Changes in plasma markers for atherosclerosis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Dietary Supplement: Omega 3 fatty acid (Lovaza)
- Lovaza LVZ112737, formerly known as Omacor.
- Omega 3 fatty acids are also available over the counter but Lovaza is a proprietary form.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301794
|Contact: Jorge Plutzky, MDfirstname.lastname@example.org|
|Contact: Jon Brown, MDemail@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Sutanuka Lahiri 617-525-6823 Sutanuka Lahiri <SLAHIRI@PARTNERS.ORG>|
|Contact: Jorge Plutzky 326-055-200 firstname.lastname@example.org|
|Principal Investigator:||Jorge Plutzky, MD||Brigham and Women's Hospital|
|Study Director:||Jonathan Brown, MD||Brigham and Women's Hospital|