Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Completed NCT02250105 - Trial of ARI-3037MO to Reduce Triglyceride Levels in Adults With Severe (≥500 mg/dl) Hypertriglyceridemia Phase 2
Completed NCT02859129 - Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®) Phase 1
Completed NCT01437930 - Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients N/A
Completed NCT01455844 - TRIal For Efficacy of Capre on hyperTriglyceridemiA Phase 2
Completed NCT01010399 - Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects Phase 4
Completed NCT00519714 - A Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA) Phase 2/Phase 3
Recruiting NCT00186537 - Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides. N/A
Completed NCT00246402 - Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV N/A
Completed NCT06020950 - Chia Seeds Consumption in Hypertriglyceridemia N/A
Completed NCT02354976 - A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects. Phase 2
Completed NCT04966494 - Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women N/A
Completed NCT04630366 - A Phase 1, First Time in Humans Study of NST-1024 Phase 1
Completed NCT04650152 - Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
Completed NCT03693131 - Efficacy of MND-2119 in Participants With Hypertriglyceridemia Phase 3
Completed NCT02868177 - Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes Phase 2/Phase 3
Completed NCT04756180 - An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia. Phase 3
Completed NCT01968720 - Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia Phase 2
Completed NCT01462877 - A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic Phase 4
Completed NCT01211847 - Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia Phase 2