Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Homeostasis model of assessment for insulin resistence index (HOMA-IR index)
研究概览
简要总结
The purpose of this study is to compare the effect of valsartan and perindopril on HOMA-IR Index in patients with chronic kidney disease.
详细描述
eligiable volunteers are administrated single-dose over the period I and II (crossover) of Valsartan (80mg) as of Perindopril (4mg).
Every time before and after each medication, HOMA-IR index and other parameters and safety of Valsartan (80mg) and Perindopril (4mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic kidney disease
- •Serum creatinine:1~3mg/dl
排除标准
- •Patients treated with corticosteroids or immunosuppressants
- •BMI>30kg/m2
- •SP>180mmHg, DP>110mmHg
- •Patients with serious medical problems requiring specific medical treatment
研究组 & 干预措施
Valsartan
Valsartan 80mg/tablet, 1 tablet once daily (crossover)
干预措施: Valsartan (Drug)
Perindopril
Perindopril 4mg/tablet, 1 tablet once daily (crossover)
干预措施: Perindopril (Drug)
结局指标
主要结局
Homeostasis model of assessment for insulin resistence index (HOMA-IR index)
时间窗: 4 weeks
HOMA-IR=FINS\*FGLU/22.5
次要结局
- Glomerular filtration rate(eGFR) and Creatinine clearance rate(CCR)(4 weeks)
- Body mass index(BMI)(4 weeks)
- 24-h urine protein, urinary albumin-creatinin ration, retinol binding protein(4 weeks)
- Cholesterol, triglycerides, high density lipoprotein, low density lipoprotein(4 weeks)
- Glycosylated hemoglobin(4 weeks)
研究者
Ri-Bao Wei
Nephrology
Chinese PLA General Hospital