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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014