Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Type 2 Diabetes
Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes
The patients who have achieved LDL-C levels below the currently recommended targets may still experience cardiovascular events. To reduce further the risk of coronary heart disease (CHD), raising HDL-C and lowering TG may be the secondary therapeutic target. However, increased HDL-C levels do not mean increase in functional HDL-C. It also remains controversial whether functional HDL is more important than total circulating levels of HDL-C in reducing CHD.
Actually, the increased concentration of HDL alone might be ineffective indicating that qualitative changes in HDL levels in response to drug interventions are required to result in clinical benefit.
The investigators set up a clinical trial investigating effect of (rosuva)statin treatment on functional HDL-C levels particularly in Asian populations, who have relatively low HDL-C.
研究概览
详细说明
- Study design Study subject Number of Subjects (N = 30)
Study outcome
Primary outcome - functional HDL-C Secondary outcome - Non-HDL cholesterol
- Evaluation of functional aspect of HDL Cholesterol efflux from macrophages LDL-induced monocyte chemotactic activity (MCA) Assay Quantitation of gene expression of monocyte chemotactic protein-1 (MCP-1)
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Seongnam、大韩民国
- Seoul National University Bundang Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Type 2 diabetes
- HbA1c ≥ 7.5%
- Age ≥ 30
- low HDL-C (<40 mg/dl in men or <50 mg/dl in women) and having 1 or more risk factors: 1) Body mass index (BMI) ≥ 25 kg/m2 (overweight); 2) LDL-C level ≥ 130 mg/dl; 3) TG level ≥150 mg/dl; 4) Systolic blood pressure (SBP)/diastolic blood pressure (DBP) ≥140/90 mmHg or taking antihypertensive medication; 5) Current smoker; 6) Family history of CHD.
Exclusion Criteria:
- Contraindication to rosuvastatin
- Pregnant or breast feeding women
- Reproductive-age women who refuse contraception
- Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
- Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal)
- Renal failure (Cr > 2.0)
- Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment)
- Not appropriate for lipid lowering treatment
- Medications which affect glycemic control
- Diseases which affect efficacy and safety of statin
- Other clinical trial within 30 days
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Rosuvastatin
Rosuvastatin will be started in type 2 DM and having 1 or more cardiovascular risk factors
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Rosuvastatin 20mg once a daily for 12 weeks
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Functional HDL-C
大体时间：12 weeks
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12 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Non-HDL-cholesterol = total cholesterol - HDL-C
大体时间：12 weeks
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12 weeks
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Patients with LDL-C < 70 mg/dl and HDL > 40 mg/dl in men; > 50 in women
大体时间：12 weeks
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12 weeks
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合作者和调查者
调查人员
- 首席研究员：Soo Lim, PHD、Seoul National University Bundang Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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