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Completed

NCT Number: NCT00345124

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

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.

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Key information

Conditions

Essential Hypertension and Healthy Controls Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medical Research, Holstebro Hospital

Holstebro, 7500, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Sodium Diet

Behavioral

250-350 mmol

Other names: For four days

Low Sodium Diet

Behavioral

25-35 mmol

Other names: For four days

Primary outcomes

  1. u-AQP-2

    Time frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  2. fractional sodium excretion

    Time frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  3. p-vasopressin

    Time frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  4. p-aldosterone

    Time frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

Secondary outcomes

  1. u-p-AQP-2

    Time frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  2. u-ENaC(alfa,beta,gamma)

    Time frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  3. CH2O

    Time frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  4. u-cAMP

    Time frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  5. uPGE2

    Time frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

  6. GFR

    Time frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 27, 2006
Registry last updated
Jun 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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