Effect of Morning Versus Evening Perindopril on Blood Pressure Control in People With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- 24-hour blood pressure profile
研究概览
简要总结
We assessed the influence of time of administration of ACE inhibitors on circadian blood pressure control in sub Saharan type 2 diabetes patients with stage 1 hypertension over 56 days as first line treatment.
详细描述
Background: Renin-angiotensin system antagonists represent the mainstay of blood pressure (BP) lowering treatment options in people with diabetes. ACE inhibitors have a long half-life and offer the advantage of a single daily dose, usually empirically taken in the morning.
Objective
We assessed the influence of time of administration of ACE inhibitors on circadian BP control in type 2 diabetes (T2D) patients with stage 1 hypertension.
Methods: Twenty T2D patients (9 being women) with a mean age of 58.7 years, diagnosed with stage 1 of hypertension and naive to BP lowering medications, were included. They were randomly allocated to receive perindopril 10 mg/day as a monotherapy either in the morning or in the evening for 28 days, with crossover without washout period on day 29th and additional 28 days follow-up. A 24-hour ambulatory BP monitoring (ABPM) was performed at baseline, days 28 and 56.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Grade 1 hypertension
- •Informed consent
排除标准
- •estimated creatinine clearance≤ 60ml/min
- •White coat hypertension after initial 24 hour ABPM
- •Previous antihypertensive treatment
- •Pregnant women
- •Individuals working during the night
- •Hyperkalemia
研究组 & 干预措施
Perindopril morning
10 mg of perindopril oral tablet once daily in the morning for 56 days
干预措施: Perindopril Oral Tablet (Drug)
Perindopril evening
10 mg of perindopril oral tablet once daily in the evening for 56 days
干预措施: Perindopril Oral Tablet (Drug)
结局指标
主要结局
24-hour blood pressure profile
时间窗: 56 days
Overall blood pressure control
次要结局
- Night time blood pressure dip(56 days)
研究者
Sobngwi Eugene
Professor of Endocrinology and Diabetes
Yaounde Central Hospital