Lovaza Mechanisms of Action
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Central trial contact
Jorge Plutzky, MD; Jon Brown, MD
Data sourced from clinicaltrials.gov
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