Comparative Effects of add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on Serum NT-PRO BNP and Proteinuria in Type 2 Diabetics With Nephropathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- N terminal brain natriuretic peptide (NT-pro BNP)
研究概览
简要总结
This study was designed to assess the efficacy of adding pentoxifylline to losartan in comparison with increasing dose of losartan in type 2 diabetes patients with nephropathy. also the effect of pentoxifylline on N terminal brain natriuretic peptide (NT-pro BNP) and C-reactive protein
详细描述
Addition of pentoxifylline to losartan provides antiproteinuric effects in type 2 diabetes patients with nephropathy that might relate to its effect on N terminal brain natriuretic peptide (NT-pro BNP) and C-reactive protein.
Pentoxifylline is a phosphodiestrase inhibitor with anti-inflammatory effects that was used in type 2 diabetes patients with nephropathy for treatment of diabetes complications.
NT-Pro BNP, which is released from the heart due to wall stress and pressures, is known as a diagnostic and prognostic marker for heart failure and cardiovascular mortality in type 2 diabetes.
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
- 38 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age>30 and age<70, urinary albumin excretion (UAE) ≥150 mg/24 h
排除标准
- •any infectious or malignant diseases, non-diabetic kidney disease, retinal hemorrhage, acute myocardial infarction, uncontrolled hypertension, pregnancy, unable to follow up, hyperthyroidism, baseline serum potassium concentrations ≥5.5 meq/L, glomerular filtration rate (GFR)<30mL/min/1.73 m and intolerance of pentoxifylline
研究组 & 干预措施
pentoxifylline & losartan
pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.
干预措施: Pentoxifylline (Drug)
pentoxifylline & losartan
pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.
干预措施: Losartan (Drug)
Losartan
losartan arm took 100mg losartan daily for 12 weeks.
干预措施: Losartan (Drug)
结局指标
主要结局
N terminal brain natriuretic peptide (NT-pro BNP)
时间窗: 3 months
N terminal brain natriuretic peptide assessed using ELISA method (zelbio, Germany) with inter- and intra-assay coefficient of variation (CV) \<12% and \<10%. Measured at baseline, 3rd month
次要结局
- Highly sensitive C-reactive protein (hsCRP)(3 months)
- Blood pressure(3 months)
- estimated glomerular filtration rate(3 months)
- Urinary albumin excretion(3 months)
- serum creatinine concentrations(3 months)