Lovaza Mechanisms of Action
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01301794|
Recruitment Status : Unknown
Verified February 2013 by Jorge Plutzky, Brigham and Women's Hospital.
Recruitment status was: Recruiting
First Posted : February 23, 2011
Last Update Posted : February 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Moderate Hypertriglyceridemia.||Dietary Supplement: Omega 3 fatty acid (Lovaza)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2014|
- Dietary Supplement: Omega 3 fatty acid (Lovaza)
Lovaza is an FDA approved omega 3 fatty acid taken as 4 grams a day (two one gram formulations twice a day).Other Names:
- Lovaza LVZ112737, formerly known as Omacor.
- Omega 3 fatty acids are also available over the counter but Lovaza is a proprietary form.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|