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CompletedNCT00345124Updated Jun 28, 2011

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

An interventional study of high sodium diet and Low Sodium Diet in Essential Hypertension and Healthy Controls, sponsored by Regional Hospital Holstebro. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-28.

Sponsored by Regional Hospital Holstebro · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Essential Hypertension and Healthy Controls

Keywords

  • urinary aquaporin-2
  • ENaC
  • fractional sodium excretion
  • High/low sodium diet
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 50 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Regional Hospital Holstebro is the lead sponsor of 50 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Interventions

  • Behavioralhigh sodium diet

    250-350 mmol

    Also known as: For four days

  • BehavioralLow Sodium Diet

    25-35 mmol

    Also known as: For four days

06

What researchers measure

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.

07

Study locations

1 site
  • Department of Medical Research, Holstebro Hospital
    Holstebro, 7500, Denmark
08

References and documents

Publications

  • Graffe CC, Bech JN, Lauridsen TG, Vase H, Pedersen EB. Abnormal increase in urinary aquaporin-2 excretion in response to hypertonic saline in essential hypertension. BMC Nephrol. 2012 Mar 27;13:15. doi: 10.1186/1471-2369-13-15. PubMed 22452789 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00345124
Lead sponsor
Regional Hospital Holstebro
First posted
Jun 27, 2006
Start date
May 2006
Primary completion
May 2009
Completion
Aug 2009
Last update
Jun 28, 2011

Study contacts

Erling B. Pedersen, Professor
study chair · Department of Medical Research, Holstebro Hospital, Denmark
Carolina C. Graffe, MD
principal investigator · Department of Medical Research, Holstebro Hospital, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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