The Influence of High and Low Salt on Exosomes in the Urine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in epithelial sodium channel (ENaC) appearance in urinary exosomes
研究概览
简要总结
The hypothesis is that changes in the epithelial sodium channel (ENaC) in the kidney is reflected in urinary exosomes and that the amount of ENaC as well as the cleavage degree is upregulated in conditions with low salt.
详细描述
Methods:
Exosomes will be isolated from spot urine by ultracentrifugation and tested using western blotting. In-house developed antibodies against different parts of the ENaC gamma subunit as well as commercial antibodies will be used. A marker for exosomes will validate the presence of exosomes in the urine.
Power considerations:
In this cross over salt-intervention study with quantification of ENaC the investigators refer to a published study regarding the sodium-chloride co-transporter (NCC) in the kidney, were rats where given aldosterone infusion or a low salt diet. In this study n=6 was sufficient to detect a 2-3 fold change in NCC in urinary exosomes. Furthermore 5 patients with primary aldosteronism had a significant increase in NCC in urinary exosomes (N. Lubbe et al, Hypertension 2012).
On the basis of this the investigators choose to test 10 persons, but are not able to make a regular power calculation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
open label
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men aged 20-40
- •Body Mass Index (BMI, weight/height^2) between 18 and 25.
排除标准
- •Increased blood pressure (hypertension) or in treatment for high blood pressure
- •Regular medical intake
- •Expectation of lacking cooperation or lack of understanding of the experiment
- •Clinical relevant organic or systemic disease including malign disease
- •Decreased kidney function
研究组 & 干预措施
Healthy male test subjects 1-5
High salt diet followed by low salt diet
干预措施: High salt diet followed by low salt diet (Dietary Supplement)
Healthy male test subjects 6-10
Low salt diet followed by high salt diet
干预措施: Low salt diet followed by high salt diet (Dietary Supplement)
结局指标
主要结局
Changes in epithelial sodium channel (ENaC) appearance in urinary exosomes
时间窗: After 5 days on high or low salt diet
Semiquantitative western blotting
次要结局
- Plasma aldosterone(Before study start and after 5 days on high or low salt diet)
- Renin(Before study start and after 5 days on high or low salt diet)
研究者
Rikke Zachar Langkilde
MD, phd student
University of Southern Denmark