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

Healthy Humans Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345215
• Other study ID #: med.res.hos.2006.cc.01
• Status: Completed
• Phase: N/A
• First received: June 24, 2006
• Last updated: June 27, 2011
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: June 2011
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Humans

Intervention

Behavioral:
• High Sodium Diet
250-350 mmol
• Low Sodium Diet
25-35 mmol

Locations

Country	Name	City	State
Denmark	Department of Medical Research, Holstebro Hospital	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	u-AQP-2		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Primary	fractional sodium excretion		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Primary	p-aldosterone		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Secondary	u-pAQP-2		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Secondary	u-ENaC(alfa-beta-gamma)		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Secondary	CH20		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Secondary	ucAMP		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Secondary	uPGE2		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Secondary	GFR		Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.