The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension

Not Applicable

Completed

• Conditions: Essential Hypertension and Healthy Controls

• Registration Number: NCT00345124
• Lead Sponsor: Regional Hospital Holstebro

Brief Summary

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.

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: 2009-05
• Study Completion: 2009-08
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-27
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Caucasian men and women
• Age 18-65 years
• Arterial hypertension
• Body mass index between 18.5 and 30 kg/m2

Exclusion Criteria

• 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

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-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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

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