Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Functional HDL-C
研究概览
简要总结
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.
详细描述
- Study design Study subject Number of Subjects (N = 30)
- Study outcome
Primary outcome - functional HDL-C Secondary outcome - Non-HDL cholesterol 3. 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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •HbA1c ≥ 7.5%
- •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.
排除标准
- •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
研究组 & 干预措施
Rosuvastatin
Rosuvastatin will be started in type 2 DM and having 1 or more cardiovascular risk factors
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Functional HDL-C
时间窗: 12 weeks
1. Cholesterol efflux from macrophages 2. LDL-induced monocyte chemotactic activity (MCA) Assay 3. Quantitation of gene expression of monocyte chemotactic protein-1 (MCP-1)
次要结局
- Non-HDL-cholesterol = total cholesterol - HDL-C(12 weeks)
- Patients with LDL-C < 70 mg/dl and HDL > 40 mg/dl in men; > 50 in women(12 weeks)
研究者
Soo Lim
Professor
Seoul National University Bundang Hospital