The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Autosomal Dominant Polycystic Kidney Disease, During Basal Conditions and After Hypertonic Saline Infusion.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- u-AQP-2CR
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 autosomal dominant polycystic kidney disease.
- if an abnormal function of the principal cells is present in autosomal dominant polycystic kidney disease, this will become more pronounced at high and low sodium intake.
详细描述
Recruitment:
The patients with ADPKD are recruited from the Outpatient Nephrology Clinic of the Department of Medicine, Holstebro Hospital (Holstebro, Denmark). The control subjects are recruited by advertising in public institutions and private companies.
Number of Subjects:
A difference in u-AQP2CR of 40 ng/mmol is considered the minimal relevant difference. A sample size of 10 subjects, who can be evaluated, has 80% power to detect this difference assuming a level of significance of 5% and an SD of 30 ng/mmol. Because a few subjects are expected to drop out, 14-15 subjects will be included in each group.
Experimental Procedure Before the Study Day:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •BMI between 18,5-30,0 kg/m2
- •ADPKD, diagnosed by the following findings on ultra scan:
- •for patients without ADPKD family history: > 5 bilateral cysts
- •for patients with ADPKD family history: < 30 years: 2 cysts (unilateral or bilateral) 30-60 years: 2 or more bilateral cysts > 60 years: 4 or more bilateral cysts
- •Kidney function: stadium 1-4.
排除标准
- •Other kidney disease
- •Anamnestic or clinical signs of acute myocardial infarction, atrial fibrillation, heart valve disease or chronic heart failure
- •Anamnestic or clinical signs of disease in lungs, liver,endocrine organs or brain or neoplastic disease
- •Family history of rupture of intracerebral aneurisms
- •Alcohol or drug abuse
- •Medical treatment arat form antihypertensives and oral anticonceptives
- •Pregnancy or breastfeeding
研究组 & 干预措施
Patients with ADPKD, HS
Each subject was studied on 2 separate days at least 3 weeks apart. During 4 days before the study day, the subjects consumed either a high sodium diet or a low sodium diet in randomized order (HS-LS/ LS-HS). On the study day a hypertonic saline infusion was given.
干预措施: High Sodium Diet (Behavioral)
Patients with ADPKD, HS
Each subject was studied on 2 separate days at least 3 weeks apart. During 4 days before the study day, the subjects consumed either a high sodium diet or a low sodium diet in randomized order (HS-LS/ LS-HS). On the study day a hypertonic saline infusion was given.
干预措施: Hypertonic saline infusion (Behavioral)
Patients with ADPKD, LS
Each subject was studied on 2 separate days at least 3 weeks apart. During 4 days before the study day, the subjects consumed either a high sodium diet or a low sodium diet in randomized order (HS-LS/ LS-HS). On the study day a hypertonic saline infusion was given.
干预措施: Low Sodium Diet (Behavioral)
Patients with ADPKD, LS
Each subject was studied on 2 separate days at least 3 weeks apart. During 4 days before the study day, the subjects consumed either a high sodium diet or a low sodium diet in randomized order (HS-LS/ LS-HS). On the study day a hypertonic saline infusion was given.
干预措施: Hypertonic saline infusion (Behavioral)
Healthy Control Subjects, HS
Each subject was studied on 2 separate days at least 3 weeks apart. During 4 days before the study day, the subjects consumed either a high sodium diet or a low sodium diet in randomized order (HS-LS/ LS-HS). On the study day a hypertonic saline infusion was given.
干预措施: High Sodium Diet (Behavioral)
Healthy Control Subjects, HS
Each subject was studied on 2 separate days at least 3 weeks apart. During 4 days before the study day, the subjects consumed either a high sodium diet or a low sodium diet in randomized order (HS-LS/ LS-HS). On the study day a hypertonic saline infusion was given.
干预措施: Hypertonic saline infusion (Behavioral)
Healthy Control Subjects, LS
Each subject was studied on 2 separate days at least 3 weeks apart. During 4 days before the study day, the subjects consumed either a high sodium diet or a low sodium diet in randomized order (HS-LS/ LS-HS). On the study day a hypertonic saline infusion was given.
干预措施: Low Sodium Diet (Behavioral)
Healthy Control Subjects, LS
Each subject was studied on 2 separate days at least 3 weeks apart. During 4 days before the study day, the subjects consumed either a high sodium diet or a low sodium diet in randomized order (HS-LS/ LS-HS). On the study day a hypertonic saline infusion was given.
干预措施: Hypertonic saline infusion (Behavioral)
结局指标
主要结局
u-AQP-2CR
时间窗: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Urinary Aquaporin-2 corrected for creatinine
次要结局
- u-ENaC (beta)CR(Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.)
- FENa(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.)
- uPGE-2(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.)
- p-vasopressin(Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.)
- p-aldosterone.(Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.)
研究者
Carolina Cannillo
Principal Investigator, PhD, MD
Regional Hospital Holstebro