Increased Activity of the Epithelial Sodium Channel (ENaC) in Diabetic Nephropathy
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 24-hour urinary sodium excretion induced by amiloride
研究概览
简要总结
The purpose of the study is to determine whether a diuretic drug called amiloride is capable of increasing renal salt excretion and thereby decrease blood pressure in diabetic patients with kidney disease. Our hypothesis states that amiloride is capable of reducing blood pressure in these patients and thus decrease the cardiovascular risk associated with diabetic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Negative pregnancy test at inclusion and taking contraceptive medication
- •One group with diabetic nephropathy and overt proteinuria
- •One normoalbuminuric group without nephropathy
- •Creatinine clearance > 40 ml/min
排除标准
- •Type 2 diabetes
- •Receiving amiloride, glucocorticoids, aldosterone or spironolactone
- •Clinically relevant organic or systemic disease including malignancy
研究组 & 干预措施
Nephropathy
Diabetics with diabetic nephropathy receiving first a standardized salt diet (200 mmol NaCl/day) for 4 days and then amiloride tablet 20 mg two times daily (morning and afternoon) for 2 days.
干预措施: Standardized salt diet (Dietary Supplement)
Nephropathy
Diabetics with diabetic nephropathy receiving first a standardized salt diet (200 mmol NaCl/day) for 4 days and then amiloride tablet 20 mg two times daily (morning and afternoon) for 2 days.
干预措施: Amiloride (Drug)
Control
Diabetics without nephropathy receiving a standardized salt diet (200 mmol NaCl/day) for 4 days, then amiloride tablet 20 mg two times daily (morning and afternoon) for 2 days.
干预措施: Standardized salt diet (Dietary Supplement)
Control
Diabetics without nephropathy receiving a standardized salt diet (200 mmol NaCl/day) for 4 days, then amiloride tablet 20 mg two times daily (morning and afternoon) for 2 days.
干预措施: Amiloride (Drug)
结局指标
主要结局
24-hour urinary sodium excretion induced by amiloride
时间窗: Change from baseline urinary sodium excretion at 24 hours after amiloride administration
次要结局
- Office blood pressure measurements(Change from baseline office blood pressure at day 4 of salt diet and at 24 hours after amiloride administration)
研究者
Henrik Andersen, MD
MD, PhD student
University of Southern Denmark