NCT00130481已完成不适用
Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Low density lipoprotein
研究概览
简要总结
The purpose of this study is to determine if Atorvastatin can improve blood vessel stiffness and blood vessel function in children 10-18 years old with Type 1 and Type 2 diabetes. Subjects will receive atorvastatin 20mg or placebo daily for 3 months and will then switch therapies for the next 3 months.
Hypothesis: Atorvastatin will improve blood vessel function by decreasing arterial stiffness and improving blood flow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) for more than 1 year
- •Age 10-18 years.
排除标准
- •Cardiovascular disease (CVD)
- •Liver disease
- •Pregnancy
- •Use of cholesterol or triglyceride lowering drugs
- •Perceived inability to comply with the study protocol
- •Endocrinopathy other than diabetes
结局指标
主要结局
Low density lipoprotein
Augmentation Index (arterial stiffness)
ENDO-PAT (Peripheral Arterial Tone) score (endothelial function)
次要结局
- Pubertal stage
- Urine microalbumin
- Body mass index (BMI)
- Blood pressure
- Glycated hemoglobin (HbA1c)
研究者
研究点 (2)
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