Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- HDL 15-HEPE
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-79 years
- •Stable does of statins ≥ 8 weeks prior to screening
- •Good health by medical history, physical exam, electrocardiogram, laboratory test (e.g., serum chem., urinalysis)
- •Mean fasting serum triglyceride of two most recent tests in medical record ≥ 200 and < 500 mg/dL
- •Mean LDL-cholesterol of two most recent tests in medical record ≤ 1.1 × NCEP ATP III goal
排除标准
- •Medications, vitamin pills, nutritional supplements or herbal preparations deemed exclusionary per primary investigator for possible interference
- •Poorly controlled diabetes mellitus (e.g. [HbA1c] > 8.0%)
- •History of a cardiovascular event
- •Past revascularization procedure
- •Past aortic aneurysm or an aortic dissection < 6 months prior to screening
- •History of pancreatitis
- •Sensitivity to any statin OR to omega-3 fatty acids or fish products
- •Poorly controlled hypertension (i.e.: >=160 systolic (resting) and/or >=100 diastolic (resting)) at 2 consecutive visits
- •Serum Creatinine ≥ 2.0 mg/dL
- •Serum transaminase > 1.5 × upper limit of normal (ULN); including aspartate aminotransferase [AST] or alanine aminotransferase [ALT]; 31 U/L for AST, 45 U/L for ALT
- •Creatine Kinase (CK) > 3.0 × ULN
- •Taking other triglyceride lowering drugs (e.g., niacin, fibrates) or fish oil supplements providing more than 500 mg of EPA+DHA per day
- •Contraindications for Lovaza per product insert
- •Women who are pregnant or nursing
研究组 & 干预措施
Lovaza
Lovaza was given as the only agent; there was no comparator agent or arm
干预措施: Lovaza (Drug)
结局指标
主要结局
HDL 15-HEPE
时间窗: 4 months
high density lipoprotein level of 15-HEPE
次要结局
未报告次要终点
研究者
William S. Harris
Adjunct Senior Scientist
Sanford Research