Clinical Study Evaluating the Nephroprotective Effect of Nicorandil in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- prevention of progression of kidney disease as measured by KDIGO.
研究概览
简要总结
This study aims to evaluate the possible nephroprotective effect of nicorandil in patients with type 2 diabetes mellitus .
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients newly diagnosed with T2DM with diet control and good glycemic index ( Hb A1C< 7 )
- •Age range between 18 and 60 years old.
- •Both sexes.
- •Stage 1and Stage 2 CKD according to KDIGO .
- •Controlled HTN .
排除标准
- •Pregnant and lactating females.
- •Patients with hypersensitivity to nicorandil.
- •Other Causes of CKD or Nephropathy eg : Uncontrolled HTN , Renal Malignancy , collagen disease as Amyloidosis and some autoimmune disease as ( SLE and Rh.fever ) .
- •Uncontrolled HTN and its antihypertensive medications ( ACEI , ARB ) and other antihypertensive medications .
- •Patients receiving nephrotoxic drugs as aminoglycosides, non-steroidal anti inflammatory drugs and contrast media.
研究组 & 干预措施
Nicorandil group
this group will include 23 patients who will receive a combination of metformin 2g/day and nicorandil 10 mg twice daily. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be uptitrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks .
干预措施: Nicorandil 10 MG Oral Tablet (Drug)
结局指标
主要结局
prevention of progression of kidney disease as measured by KDIGO.
时间窗: 12 weeks
Patients wii undergo clinical assesment for progression of diabetic nephropathy as measured by KDIGO at baseline and after 12 weeks
次要结局
- change in the serum concentrations of Kidney injury molecule 1(Kim-1).(12 weeks)
- change in the serum concentrations of Interleukin 18 (IL-18).(12 weeks)
- change in the serum concentrations of Nitric oxide (NO).(12 weeks)
研究者
Mohammed Atta Ali El-Hazzab
Principal Investigator
Tanta University