The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers for the Measurement of Sodium and Water Channel Activity in the Nephron in Healthy Young Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Renal biomarkers
研究概览
简要总结
The kidneys have numerous salt and water channels and play a major role in the regulation of sodium and water. We do not know how these channels work in certain water and sodium accumulating medical conditions.
The purpose of this study is to identify and measure the activity in the water and sodium channels by measuring urine biomarkers/proteins in young healthy subjects.
详细描述
25 healthy subjects from age 18-45 are recruited.
Subjects will be examined on three examination days. Four days prior to the examination days the subjects will consume a standard diet based on the amount of sodium and calories.
On the examination day subjects are randomised to an infusion with either isotonic saline 23 ml/kg, hypertonic saline 7 ml/kg or glucose 23 ml/kg for a period of 50 minutes.
Renal function is measured by renal clearance of 51Cr-EDTA, urinary sodium, potassium and creatinine.
Urinary NCC, NKCC and ENAC will be measured to evaluate the activity of sodium channels in the nephron.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy males and females
- •age 18-45
- •BMI range 18,5-30,0 kg/m2
排除标准
- •hypertension (ie ambulatory BP >130 mmHg systolic or/and >80 mmHg diastolic)
- •history or clinical significant signs of heart, lung, liver, kidney, endocrine, brain or neoplastic disease.
- •alcohol abuse
- •drug abuse
- •pregnancy or nursing
- •blood donation within a month prior to examination
- •Medical treatment apart from oral contraception
结局指标
主要结局
Renal biomarkers
时间窗: day one
Urinary epithelial sodium channels (ENaC), Sodium-Chloride transporters (NCC), Sodium-potassium-2chloride transporters (NKCC) and aquaporin2 channels (AQP2) before, during and after fluid infusion
次要结局
- blood hormones regulating salt, water and blood pressure(day one)
研究者
Erling Bjerregaard Pedersen
DMSc
Regional Hospital Holstebro