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

Essential Hypertension and Healthy Controls Clinical Trial

Official title:

The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension, During Basal Conditions and After Hypertonic Saline Infusion.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345124
• Other study ID #: med.res.hos.2006.cc.02
• Status: Completed
• Phase: N/A
• First received: June 24, 2006
• Last updated: June 27, 2011
• Start date: May 2006
• Est. completion date: August 2009

Study information

• Verified date: June 2011
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension and Healthy Controls
• Hypertension

Intervention

Behavioral:
• high sodium diet
250-350 mmol
• Low Sodium Diet
25-35 mmol

Locations

Country	Name	City	State
Denmark	Department of Medical Research, Holstebro Hospital	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	u-AQP-2		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Primary	fractional sodium excretion		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Primary	p-vasopressin		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Primary	p-aldosterone		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Secondary	u-p-AQP-2		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Secondary	u-ENaC(alfa,beta,gamma)		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Secondary	CH2O		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Secondary	u-cAMP		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Secondary	uPGE2		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Secondary	GFR		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.