Optimal Dose of Irbesartan for Renoprotection in Type 2 Diabetic Patients With Persistent Microalbuminuria
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- urinary albumin excretion rate
研究概览
简要总结
Aim: To evaluate the renoprotective effect as reflected by short-term changes in albuminuria of ultra high doses of irbesartan in Type 2 diabetic patients with microalbuminuria Design: A double-masked randomized cross-over trial including 60 hypertensive Type 2 diabetic patients with microalbuminuria on ongoing antihypertensive medication. At inclusion, previous antihypertensive treatment will be discontinued and replaced with bendroflumethiazide 5 mg o.d. for the entire study. Following two months wash-out (baseline), patients will be treated randomly with irbesartan 300, 600 and 900 mg o.d., each dose for two months. End-points evaluated at the end of each study period include urinary albumin excretion rate (UAE, mean of three 24-hrs collections), 24-hrs blood pressure (ABP); and GFR (51Cr-EDTA).
详细描述
Aim:
The primary aim of our study is to evaluate the antiproteinuric effect of irbesartan 300, 600 and 900 mg once daily in type 2 diabetic patients with microalbuminuria. Secondary to evaluate the effect on 24-h ambulatory blood pressure, glomerular filtration rate (GFR), urinary TGF beta excretion, and markers of endothelial dysfunction, and finally to evaluate the association between treatment response and genotypes with possible implications for the risk of cardiovascular disease.
Patients 60 type 2 diabetic patients with persistent microalbuminuria (at least two out of three 24-h urinary collections with albumin excretion between 30 and 300 mg/24-h).
Duration of study 38 weeks (8 weeks wash-out and 30 weeks of double-blind randomized cross-over (treatment with irbesartan 300, 600 and 900 mg for 10 weeks at each dose level)).
Design The study consists of an eight week wash-out period followed by a double-blind randomized three 10 week treatment period cross-over trial (please see enclosed flow chart).
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
- Double
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
- •Type 2 diabetes (WHO criteria) and age above 18 years.
- •Persistent microalbuminuria (urinary albumin excretion between 30 and 300 mg/24-h in at least two out of three 24-urinary collections
- •Systolic blood pressure > 110 mmHg
排除标准
- •Serum creatinine > 150 micromol/l
- •Known non-diabetic renal disease
- •Pregnancy or fertile women not using adequate contraception (intrauterine device, sterilization or oral anticonception)
- •Systolic blood pressure persistently > 180 mm Hg or < 100 mm Hg
- •Diastolic blood pressure persistently > 105 mm Hg
- •Plasma potassium > 4.8 mmol/l
- •Heart failure, acute myocardial infarction, unstable angina or coronary by-pass surgery within the previous three months.
- •Known intolerance to angiotensin II receptor blockers
结局指标
主要结局
urinary albumin excretion rate
次要结局
- ambulatory blood pressure
- glomerular filtration rate
- serum potassium
- serum creatinine
- lipids
- renin
- aldosterone
- NT-proBNP
- markers of endothelial function
- markers of inflammation
- genotypes with possible implications for the risk of cardiovascular disease