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

This study has been completed.
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00345215
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 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


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

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-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-pAQP-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 ]
  • CH20 [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ] [ Designated as safety issue: No ]
  • ucAMP [ 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: 26
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: High Sodium Diet
    250-350 mmol
    Behavioral: Low Sodium Diet
    25-35 mmol
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345215

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

Responsible Party: Carolina Cannillo Graffe, Department of Medical Research, Holstebro Hospital
ClinicalTrials.gov Identifier: NCT00345215     History of Changes
Other Study ID Numbers: med.res.hos.2006.cc.01
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
High/low Sodium Diet
Fractional Sodium Excretion

ClinicalTrials.gov processed this record on May 23, 2013