The Influence of Statins on Glucose Homeostasis and the Biomarkers of Diabetes in Subjects With Impaired Fasting Glucose
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Glucose homeostasis
研究概览
简要总结
Evaluate the effects of rosuvastatin (maybe the highest diabetogenic) and pravastatin (seems to be protective) on the glucose homeostasis and other biomarkers in subjects with impaired fasting glucose.
详细描述
Statin therapy effectively reduces cardiovascular events. However, trial data1 and meta-analyses suggest that statins also confer increased risk of development of diabetes. In order to elucidate whether statins increase risk of diabetes, investigators conducted this study to evaluate the effects of rosuvastatin (maybe the highest diabetogenic) and pravastatin (seems to be protective) on the glucose homeostasis and other biomarkers in subjects with impaired fasting glucose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 35-70 years old
- •Fasting blood glucose 100-125 mg/dL
排除标准
- •2hr glucose during OGTT >200 mg/dL
- •Total cholesterol >280 mg/dL
- •Previous diabetic history, coronary artery disease
- •Allergy to rosuvastatin or parvastatin
- •Baseline ALT more than 3 times UNL
- •Serum Cr > 2.0 mg/dL
- •Pregnancy, breast feeding or plan to be pregnant woman.
研究组 & 干预措施
Control
IFG subjects with total cholesterol less than 200 mg/dL will be served as controls.
干预措施: Control (Drug)
Pravastatin
The impaired fasting glucose (IFG) subjects with total cholesterol 200-280 mg/dL will be randomized into two groups: pravastatin 40 mg or rosuvastatin 10 mg.
干预措施: Pravastatin (Drug)
Rosuvastatin
The impaired fasting glucose (IFG) subjects with total cholesterol 200-280 mg/dL will be randomized into two groups: pravastatin 40 mg or rosuvastatin 10 mg.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Glucose homeostasis
时间窗: 6 months
Compare the glucose homeostasis and some biomarkers of diabetes among control, parvastatin and rosuvastatin groups. Glucose and insulin response during OGTT. Some markers of insulin resistance and insulin secretion calculated from OGTT.
次要结局
- Chronic complications of diabetes(Up to 10 years)
- Some biomarkers of diabetes(6 months)
- Progression of glucose homeostasis(5 to 10 years.)
- Incidence of diabetes(5 to 10 years.)
研究者
vghtpe user
Taipei Veterans General Hospital
Taipei Veterans General Hospital, Taiwan