Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 主要终点
- systolic blood pressure
研究概览
简要总结
This randomized controlled trial was designed to assess whether a community-based treatment strategy implemented by home care nurses would be effective in controlling hypertension in First Nations people with existing hypertension and type 2 diabetes.
详细描述
Two community-based strategies for controlling hypertension in First Nations people with existing hypertension and diabetes were compared. In the intervention group, a home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy. In the control group, treatment decisions were made by each subject's primary care physician. The primary outcome measure was the difference between the 2 groups in teh change in systolic blood pressure after 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age>= 18 yr
- •Type 2 diabetes mellitus
- •Persistent hypertension (systolic pressure >= 130 mmHg, diastolic pressure >= 80 mm Hg, or both)
排除标准
- •use of beta blocker
- •women of child-bearing age not able to use a reliable method of birth control
- •Connective tissue disorder
- •Severe systemic or malignant disease
- •Inability to follow the protocol
- •Bilateral renal artery stenosis and other causes of secondary hypertension
- •Serum creatinine level > 250 micromol/L
- •cerebrovascular even within 6 mo
- •valvular heart disease
- •unstable angina
- •Myocardial infarction
- •Revascularization procedure within 3 mo before study recruitment
- •heart failure
- •cardiac arrhythmia requiring medical treatment or heart block
- •active hepatic disease
结局指标
主要结局
systolic blood pressure
时间窗: 12 months
次要结局
- Change in diastolic blood pressure, change in urine albumin status and incidence of adverse events(12 months)
研究者
Sheldon Tobe
Principal Investigator
Sunnybrook Health Sciences Centre