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Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia — ELLF  

Hypertriglyceridemia Clinical Trial

Official title:
Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia

Clinical Trial Summary

This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).

Clinical Trial Description

This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00959842
Study type Interventional
Source Sanford Research
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2009
Completion date February 2010
View Details
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