Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Glucose tolerance assessed by HbA1c and fasting glucose
研究概览
简要总结
Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia, promotes the development of coronary heart disease. Secondary dyslipidemia is often associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading to a significant reduction of cardiovascular risk. More recently, revisions to guidelines have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring the administration of higher dose of statin. However, it is unclear whether high dose statin therapy could affect glycemic control in diabetic patients. Moreover, data regarding the effects of statins on insulin-resistance and endothelial function are controversial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes in good glycemic control, treated with metformin alone.
- •Untreated dyslipidemia.
- •BMI <30.
排除标准
- •History of cancer.
- •History of cardiovascular diseases.
- •Any other acute or cronic illness which requires administration of steroids or other drugs able to interfere with glucose metabolism.
研究组 & 干预措施
Simvastatin
Simvastatin 20 mg/day
干预措施: Simvastatin (Drug)
Rosuvastatin
Rosuvastatin 20 mg/day
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Glucose tolerance assessed by HbA1c and fasting glucose
时间窗: 1, 6, 12 months
次要结局
- insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.(1, 6, 12 months.)