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

This study has been completed.
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00345124
First received: June 24, 2006
Last updated: June 27, 2011
Last verified: June 2011
History of Changes
  Purpose

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.

Condition Intervention
Essential Hypertension and Healthy Controls
 Behavioral: high sodium diet
Behavioral: Low Sodium Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • u-AQP-2 [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ] [ Designated as safety issue: No ]
  • fractional sodium excretion [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ] [ Designated as safety issue: No ]
  • p-vasopressin [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ] [ Designated as safety issue: No ]
  • p-aldosterone [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • u-p-AQP-2 [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ] [ Designated as safety issue: No ]
  • u-ENaC(alfa,beta,gamma) [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ] [ Designated as safety issue: No ]
  • CH2O [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ] [ Designated as safety issue: No ]
  • u-cAMP [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ] [ Designated as safety issue: No ]
  • uPGE2 [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ] [ Designated as safety issue: No ]
  • GFR [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2006
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: high sodium diet
    250-350 mmol
    Other Name: For four days
    Behavioral: Low Sodium Diet
    25-35 mmol
    Other Name: For four days
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345124

Locations
Denmark
Department of Medical Research, Holstebro Hospital
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Study Chair: Erling B. Pedersen, Professor Department of Medical Research, Holstebro Hospital, Denmark
Principal Investigator: Carolina C. Graffe, MD Department of Medical Research, Holstebro Hospital, Denmark
  More Information

No publications provided by Regional Hospital Holstebro

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Carolina Cannillo Graffe, Department of Medical Research, Holstebro Hospital
ClinicalTrials.gov Identifier: NCT00345124     History of Changes
Other Study ID Numbers: med.res.hos.2006.cc.02
Study First Received: June 24, 2006
Last Updated: June 27, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Regional Hospital Holstebro:
urinary aquaporin-2
ENaC
fractional sodium excretion
High/low sodium diet

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013