A Trial to Compare the Effects of Nebivolol Versus Atenolol on Various Cardiovascular Measurements Including Insulin Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Insulin Sensitivity Index (ISI)
研究概览
简要总结
The purpose of this study is to conduct a randomised trial to compare the insulin sensitivity, 24 hour blood pressure profile, and tolerability of nebivolol plus a thiazide-like diuretic versus atenolol plus a thiazide-like diuretic.
详细描述
Retrospective studies of treated hypertensive cohorts have strongly implicated beta blocker therapy as increasing the risk of developing new-onset diabetes. This has led to the latest British Hypertension Society guidelines advising caution when using beta blockers particularly in combination with thiazide-like diuretics. However the National Institute of Clinical Excellence recommends beta-blocker + thiazide combinations as the treatment of choice in patients who are not at increased risk of developing diabetes. Nebivolol is a newer class of beta blocker. Some studies in diabetic hypertensive patients have suggested that nebivolol does not impair insulin sensitivity. The aim of this study is to compare the effect on insulin sensitivity of nebivolol versus atenolol, both in combination with a thiazide-like diuretic, in a group of non-diabetic hypertensive patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 or above
- •Blood pressure that meets any of the three following criteria:
- •BP should be <140/85 mmHg on a maximum of two anti-hypertensive drugs
排除标准
- •contraindications to beta-blockade
- •contraindications to thiazide use
- •if there was a history of asthma, diabetes, heart failure, bradycardia, atrial fibrillation, AV conduction disturbances
- •concurrent treatment with verapamil & dilitiazem
- •childbearing women
- •compelling indication for treatment with a beta blocker
- •any condition that will interfere with the treatment or the patient's ability to complete the study
研究组 & 干预措施
atenolol 25mg daily
atenolol 25mg daily
干预措施: Atenolol (Drug)
nebivolol 2.5mg daily
nebivolol 2.5mg daily
干预措施: Nebivolol (Drug)
结局指标
主要结局
Insulin Sensitivity Index (ISI)
时间窗: Baseline, 15, 30, 60, 90, 120m following oral glucose load, at baseline and at the end of each phase(8 weeks treatment
Patients were asked to fast for a minimum of 12 hours prior to each oral glucose tolerance test (OGTT). Venous blood was withdrawn for insulin and glucose analysis, 15 minutes and immediately prior to, and 30, 60, 90 and 120 minutes following an oral glucose load. For each OGTT, the Insulin Sensitivity Index (ISI) was calculated using the standard method for oral glucose tolerance testing. For each OGTT, the Insulin Sensitivity Index (ISI) was calculated using the standard method for oral glucose tolerance testing.
次要结局
- 24 Hour Systolic Blood Pressure(Before and after 8 weeks of treatment)
- Total Cholesterol(Before and after 8 weeks of treatment)
- HbA1c(Before and after 8 weeks of treatment)
- BMI(Before and after 8 weeks of treatment)