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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega 3 fatty acid (Lovaza) | Dietary Supplement | Lovaza is an FDA approved omega 3 fatty acid taken as 4 grams a day (two one gram formulations twice a day). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lipoprotein metabolite content and their ability to activate PPAR-alpha in an established cell culture system. | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in plasma markers for atherosclerosis | Subjects will also be studied before and after Lovaza for changes in lipid profile and c- reactive protein | 3 months |
| Change in plasma markers of diabetes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorge Plutzky, MD | Contact | 617-525-4360 | jplutzky@rics.bwh.harvard.edu | |
| Jon Brown, MD | Contact | 617-525-4360 | jbrown0@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Jorge Plutzky, MD | Brigham and Women's Hospital | Principal Investigator |
| Jonathan Brown, MD | Brigham and Women's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| C405603 | Omacor |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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Plasma markers of diabetes will be measure before and after Lovaza treatment for 3 months, specifically glucose and A1C levels
| 3 months |
| Changes in plasma markers of liver function | 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. | 3 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |