Clinical trial NCT00345215: The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Healthy Humans.
Official title: The Effect of High and Low Sodium Intake on Aquaporin-2 in Healthy Humans, During Basal Conditions and After Hypertonic Saline Infusion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Humans
Keywords: Urinary Aquaporin 2
High/low Sodium Diet
Fractional Sodium Excretion
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-06-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: u-AQP-2
timeFrame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
measure: fractional sodium excretion
timeFrame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
measure: p-aldosterone
timeFrame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Secondary outcomes:
measure: u-pAQP-2
timeFrame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
measure: u-ENaC(alfa-beta-gamma)
timeFrame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
measure: CH20
timeFrame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
measure: ucAMP
timeFrame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
measure: uPGE2
timeFrame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
measure: GFR
timeFrame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medical Research, Holstebro Hospital
Study officials:
affiliation: Department of Medical Research, Holstebro Hospital, Denmark
name: Erling B. Pedersen, Professor
role: STUDY_CHAIR
affiliation: Department of Medical Research, Holstebro Hospital, Denmark
name: Carolina C. Graffe, MD
role: PRINCIPAL_INVESTIGATOR
References: