Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients : Prospective, Randomized, Double Blinded Active Control, Multicenter Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Percentage Change in Proteinuia
研究概览
简要总结
This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline on proteinuria in Korean type 2 diabetic patients.
详细描述
The investigators will recruit adults patients with type 2 diabetes aged over 20 years with spot urine albumin to creatinine ratio over 30mg/g in two consecutive measurements.
Enrolled patients will be randomly assigned to receive pentoxifylline (400mg three times daily) or placebo for 24 weeks.
Fasting blood and spot urine will be collected at baseline, 12 weeks and 24 weeks.
The investigators will evaluate the impact of pentoxifylline on proteinuria in type 2 diabetic patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus
- •age >=20 years
- •spot urine albumin/creatinine ratio > 30mg/g in two consecutive measurements
- •patients on ACE-inhibitor or ARB as an anti-hypertensive drug
- •blood pressure <= 150/100 mmHg
- •HbA1c <10%
排除标准
- •taking insulin pentoxifylline, cilostazol, ketas, viagra in 3 months
- •ischemic heart disease, stroke, malignant disease, severe infection in 6 months
- •serum creatinine > 2.0mg/dl
- •severe liver disease or AST, ALT > 3* ULM
- •taking systemic steroid in 1 month
- •pregnant or plan to become pregnant during the clinical trial
- •lactation
研究组 & 干预措施
Pentoxifylline
Pentoxifylline 400mg three times a day
干预措施: Pentoxifylline (Drug)
Placebo
placebo tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage Change in Proteinuia
时间窗: baseline and 24 weeks
Changes of urine protein to creatinie ratio from baseline to 24 weeks
次要结局
- Mean Change of Fasting Glucose(baseline and 24 weeks)
- Mean Change of TNF-a(baseline and 24 weeks)
- Percentage Change in Albuminuria(baseline and 24 weeks)
- Mean Change of Creatinine(baseline and 24 weeks)
- Mean Change of eGFR(baseline and 24 weeks)
研究者
Kwan Woo Lee
professor
Ajou University School of Medicine