The Effects of Nebivolol on Aortic Impedance Parameters in Type 2 Diabetics
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Central Systolic Blood Pressure (SBP)
研究概览
简要总结
The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.
详细描述
To determine the effect of nebivolol versus metoprolol in Type 2 hypertensive diabetic patients on systolic blood pressure and diastolic blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Established Type 2 diabetic not treated with insulin
- •Stage 1 hypertensives blood pressure > 130/80 mmHg and < 160/100 mmHg
- •BMI < 35
- •Hemoglobin A1C < 8.5
- •Must be postmenopausal or taking some form of birth control of surgically sterile
排除标准
- •Acute myocardial infarction, unstable angina, stroke or TIA within the past year.
- •Active angina in the last three months
- •Diabetes requiring treatment with insulin
- •Severe asthma
- •Female who are pregnant, planning to be pregnant during the study period, lactating or women of childbearing potential who are not using a medically approved method of contraception
- •Recent history of substance or alcohol abuse .
- •Uncontrolled hypertension systolic blood pressure >160mmHg or diastolic blood pressure > 100 mmHg
研究组 & 干预措施
nebivolol
Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
干预措施: nebivolol (Drug)
Metoprolol
Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
干预措施: Metoprolol (Drug)
结局指标
主要结局
Change in Central Systolic Blood Pressure (SBP)
时间窗: Baseline and 26 Weeks
Changes in aortic impedance in patients on nebivolol vs. metoprolol succinate in Type 2 hypertensive diabetic patients as measured by the change from baseline in central systolic blood pressure.
次要结局
- Change in Pulse Pressure Amplification(Baseline and 26 Weeks)
- Change in Pulse Wave Velocity (PWV)(Baseline and 26 Weeks)
- Change in Augmentation Index(Baseline and 26 Weeks)