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Completed

NCT Number: NCT00345215

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

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

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Key information

Conditions

Healthy Humans

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

  • 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

Treatment and study plan

High Sodium Diet

Behavioral

250-350 mmol

Low Sodium Diet

Behavioral

25-35 mmol

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-aldosterone

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

Secondary outcomes

  1. u-pAQP-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. CH20

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

  4. ucAMP

    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 Aquaporin-2 in Healthy Humans, During Basal Conditions and After Hypertonic Saline Infusion.

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
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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