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

The Effect of High and Low Sodium Intake on Aquaporin-2 in Healthy Humans, During Basal Conditions and After Hypertonic Saline Infusion.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00345215

Enrollment

Registered

2006-06-27

Start date

2006-05-31

Completion date

2007-05-31

Last updated

2011-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Humans

Keywords

Urinary Aquaporin 2, High/low Sodium Diet, Fractional Sodium Excretion

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

Interventions

BEHAVIORALHigh Sodium Diet

250-350 mmol

BEHAVIORALLow Sodium Diet

25-35 mmol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
u-AQP-2	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
fractional sodium excretion	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
p-aldosterone	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

Secondary

Measure	Time frame
u-ENaC(alfa-beta-gamma)	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
uPGE2	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
ucAMP	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
CH20	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
GFR	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
u-pAQP-2	Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026