The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Healthy Humans.

Not Applicable

Completed

• Conditions: Healthy Humans

• Registration Number: NCT00345215
• Lead Sponsor: Regional Hospital Holstebro

Brief Summary

The aim of the study is to test the hypothesis that the function and/or regulation of aquaporin 2 and/or endothelial sodium channels in the principal cells of healthy humans is abnormal at high and low sodium intake

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-06-24
• Study First Submitted QC: 2006-06-24
• Study First Posted: 2006-06-27
• Primary Completion: 2006-12
• Study Completion: 2007-05
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-27
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Caucasic men and women
• Age 18-65 years
• Body mass index less or equal to 30 Kg/m2

Exclusion Criteria

• Arterial hypertension
• History or clinical signs of heart, brain, lung, kidney, malignant or endocrine organ disease.
• Abnormal biochemical screening of the blood regarding: red and white cell count, B-hemoglobin, P-sodium, P-potassium, P-creatinine, 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.
• Alcohol or drug abuse
• Drug use except oral contraceptives
• Smoking
• Abnormal electrocardiogram
• Blood donation within one month of the first examination day
• Pregnancy
• Unwillingness to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
u-AQP-2	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
fractional sodium excretion	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.

Secondary Outcome Measures

Name	Time	Method
u-pAQP-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.
CH20	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
ucAMP	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.

Trial Locations

Locations (1)

Department of Medical Research, Holstebro Hospital; 🇩🇰 Holstebro, Denmark