Effect of SGLT2 Inhibitor on Proteinuria in Diabetic Patients
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
- decrease in proteinuria
研究概览
简要总结
Diabetes Mellitus is the leading cause of end stage renal disease. As proven by many studies , controlling proteinuria can delay the progression to end stage renal disease.This work will study the effect of sodium glucose co transporter 2 inhibitor , a new antihyperglycemic drug , on proteinuria and to compare its effect with the effect of classic antiproteinuric drugs as angiotensin converting enzyme inhibitor , aspirin and statins.
详细描述
Diabetic nephropathy involves progressive stages including glomerular hyperfilteration , microalbuminuria , overt proteinuria and a decline in glomerular filteration rate leading to end stage renal disease.
Despite all the available interventions available for diabetic patients including tight glycemic control , and blood pressure control , using angiotensin converting enzyme inhibitors, angiotensin II receptor antagonist renal disease remains prevalent and progress in these patients.
The newer therapy of diabetes is the use of sodium glucose cotransporter 2 inhibitor as it has the potential of renoprotection in patients with diabetic nephropathy just as ACEI and ARBS to reduce glomerular hyperfilteration .This action may reduce albuminuria.
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
- Single (Outcomes Assessor)
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
- •adult patients with type 2 diabetes.
- •controlled diabetes.
- •patients with proteinuria
排除标准
- •patients with proteinuria due to other disease.
- •patients with HbA1c >8%.
- •patients with uncontrolled hypertension.
- •patients with chronic liver disease.
- •patients with type 1 diabetes .
- •patients already on the same drug ( dapagliflozine).
- •patients with raised serum creatinine.
研究组 & 干预措施
control
ACE inhibitor , aspirin , statins will be given once daily
干预措施: ACE inhibitor (Drug)
cases
SGLT2 inhibitors will be given with classic antiproteinuric drugs
干预措施: SGLT2 inhibitor (Drug)
cases
SGLT2 inhibitors will be given with classic antiproteinuric drugs
干预措施: ACE inhibitor (Drug)
结局指标
主要结局
decrease in proteinuria
时间窗: 6 months
improvement of proteinuria in patients receiving dapagliflozine
次要结局
未报告次要终点
研究者
Nahla H Tohami
Assistent lecturer of nephrology
Ain Shams University