NCT00345124已完成不适用
The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension, During Basal Conditions and After Hypertonic Saline Infusion.
Regional Hospital Holstebro2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- u-AQP-2
研究概览
简要总结
The aim of the study is to test the following hypotheses:
- that the function and/or regulation of AQP2 and/or ENaC in the principal cells is abnormal in essential hypertension.
- if an abnormal function of the principal cells is present in essential hypertension, this will become more pronounced at high and low sodium intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian men and women
- •Age 18-65 years
- •Arterial hypertension
- •Body mass index between 18.5 and 30 kg/m2
排除标准
- •Secondary hypertension
- •Isolated systolic hypertension
- •History or clinical signs of AMI, atrial fibrillation, disease of the heart valves, or chronic heart failure.
- •Malignant disease
- •Prior apoplexy
- •alcohol or drug abuse
- •Drug use except antihypertensives and oral contraceptives
- •Abnormal biochemical screening of the blood regarding: red and white blood count, s-creatinine (> 200 micromol/L), b-hemoglobin, p-Sodium, p- potassium, p-albumine, p-bilirubin, p-alanine aminotransferase, p-alkaline phosphatase, p-cholesterol and b-glucose.
- •Abnormal screening of the urine regarding: Blood, albumine and glucose.
- •abnormal electrocardiogram
- •Blood donation within one month of the first examination day
- •Unwillingness to participate
结局指标
主要结局
u-AQP-2
时间窗: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
fractional sodium excretion
时间窗: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
p-vasopressin
时间窗: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
p-aldosterone
时间窗: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
次要结局
- u-p-AQP-2(Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.)
- u-ENaC(alfa,beta,gamma)(Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.)
- CH2O(Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.)
- u-cAMP(Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.)
- uPGE2(Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.)
- GFR(Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.)
研究者
研究点 (2)
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