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

Sponsor

Regional Hospital Holstebro (Other)

Overall Status

Completed

CT.gov ID

NCT00345215

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Humans	Behavioral: High Sodium Diet Behavioral: Low Sodium Diet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, 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.

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00345215

Other Study ID Numbers:

med.res.hos.2006.cc.01

First Posted:

Jun 27, 2006

Last Update Posted:

Jun 28, 2011

Last Verified:

Jun 1, 2011

Keywords provided by , ,

Urinary Aquaporin 2

High/low Sodium Diet

Fractional Sodium Excretion

Study Results

No Results Posted as of Jun 28, 2011