A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- LDL cholesterol
研究概览
简要总结
People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy. Statins may not be the most effective strategy for patients on this diet, since they typically consume a greater amount of saturated fat and cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We hypothesize that patients following a low carbohydrate diet would experience a significantly greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Moderately obese with hyperlipidemia
排除标准
- •Recent unstable heart or lung condition
- •Current use of other lipid modifying drugs
- •Hepatic disease
- •Pregnancy or lactation
研究组 & 干预措施
2
Low carb diet plus simvastatin 20 mg/ezetimibe 10 mg
干预措施: simvastatin 20 mg/ezetimibe (Drug)
结局指标
主要结局
LDL cholesterol
时间窗: 8 weeks of treatment
次要结局
- Other lipid measures(8 weeks of treatment)
- Safety and tolerability(8 weeks treatment)
