- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00345215
The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Healthy Humans.
June 27, 2011 updated by: Regional Hospital Holstebro
The Effect of High and Low Sodium Intake on Aquaporin-2 in Healthy Humans, During Basal Conditions and After Hypertonic Saline Infusion.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Holstebro, Denmark, 7500
- Department of Medical Research, Holstebro Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
u-AQP-2
Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
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Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
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fractional sodium excretion
Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
p-aldosterone
Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
u-pAQP-2
Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
u-ENaC(alfa-beta-gamma)
Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
CH20
Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
ucAMP
Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
uPGE2
Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
GFR
Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
June 24, 2006
First Submitted That Met QC Criteria
June 24, 2006
First Posted (Estimate)
June 27, 2006
Study Record Updates
Last Update Posted (Estimate)
June 28, 2011
Last Update Submitted That Met QC Criteria
June 27, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- med.res.hos.2006.cc.01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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