Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Blood pressure, nighttime blood pressure and 24 h blood pressure
研究概览
简要总结
The purpose of this study is to investigate if it is possible to lower the nighttime blood pressure in patients with type 2 diabetes mellitus by shifting the administration of antihypertensive drugs from morning to nighttime.
详细描述
In recent years several studies have shown that high nighttime blood pressure is associated with increased cardiovascular risk independently of the average 24 hour blood pressure. As a consequence there has been increasing focus on nighttime blood pressure and how to lower it. One way of addressing the problem is to shift the administration of antihypertensive drugs from morning to nighttime. Studies on non-diabetic patients show that by doing this the nighttime blood pressure can be lowered with 3-5 mm Hg without negative effect on the 24 hour blood pressure.
Only recently a study was made on diabetic patients. This showed similar results as for non-diabetic patients.However this study was based on diabetic patients who did not receive any antihypertensive drugs before.
This study will investigate the effects on nighttime blood pressure when shifting administration of antihypertensive drugs from morning to nighttime. The population is diabetic patients who are already in antihypertensive treatment.
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
- None
入排标准
- 年龄范围
- 30 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
- •Systolic nighttime blood pressure above 120 mm Hg
- •Systolic daytime blood pressure not exceeding 150 mm Hg
- •Antihypertensive treatment which must include
- •once-daily drugs
- •at least one drug must be a Angiotensin-Converting Enzyme Inhibitor, Angiotensin II Receptor Blocker or Renin Inhibitor.
排除标准
- •MI or stroke within 6 months
- •heart failure (EF < 45 %)
- •atrial fibrillation
- •eGFR < 30 ml/min
结局指标
主要结局
Blood pressure, nighttime blood pressure and 24 h blood pressure
时间窗: After 16 weeks
次要结局
- Urine albumin excretion(After 16 weeks)