Randomized Study of Antihypertensives and Antilipemics in American Indians With Non-Insulin-Dependent Diabetes Mellitus at High Risk of Developing Nephropathy and Cardiovascular Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
研究概览
简要总结
OBJECTIVES:
I. Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community.
II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria.
III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients.
详细描述
PROTOCOL OUTLINE:
Patients are randomly assigned to 1 of 4 treatment groups; therapy continues for 3 years. All patients receive instruction on diet, exercise, and smoking cessation.
The first group receives daily nifedipine at a dose adjusted for high blood pressure. Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program guidelines. Diuretics and doxazosin may be given concurrently.
The second group receives daily lisinopril at a dose adjusted for high blood pressure. Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program guidelines. Diuretics and doxazosin may be given concurrently.
The third group receives daily nifedipine at a dose adjusted for high blood pressure, and simvastatin at a dose adjusted for high low-density lipoproteins. Supplemental cholestyramine may be given as needed. If cholestyramine is not tolerated or if triglycerides are high, gemfibrozil is substituted for cholestyramine.
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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nifedipine
Daily nifedipine at a dose adjusted for high blood pressure. Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program guidelines. Diuretics and doxazosin may be given concurrently.
干预措施: Nifedipine (Drug)
Lisinopril
Daily lisinopril at a dose adjusted for high blood pressure. Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program guidelines. Diuretics and doxazosin may be given concurrently.
干预措施: Lisinopril (Drug)
Nifedipine and simvastatin
Daily nifedipine at a dose adjusted for high blood pressure, and simvastatin at a dose adjusted for high low-density lipoproteins. Supplemental cholestyramine may be given as needed. If cholestyramine is not tolerated or if triglycerides are high, gemfibrozil is substituted for cholestyramine.
干预措施: Nifedipine (Drug)
Nifedipine and simvastatin
Daily nifedipine at a dose adjusted for high blood pressure, and simvastatin at a dose adjusted for high low-density lipoproteins. Supplemental cholestyramine may be given as needed. If cholestyramine is not tolerated or if triglycerides are high, gemfibrozil is substituted for cholestyramine.
干预措施: Simvastatin (Drug)
Lisinopril and simvastatin
Lisinopril at a dose adjusted for high blood pressure and simvastatin at a dose adjusted for high low-density lipoproteins.
干预措施: Lisinopril (Drug)
Lisinopril and simvastatin
Lisinopril at a dose adjusted for high blood pressure and simvastatin at a dose adjusted for high low-density lipoproteins.
干预措施: Simvastatin (Drug)