- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00345124
The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension
June 27, 2011 updated by: Regional Hospital Holstebro
The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension, During Basal Conditions and After Hypertonic Saline Infusion.
The aim of the study is to test the following hypotheses:
- that the function and/or regulation of AQP2 and/or ENaC in the principal cells is abnormal in essential hypertension.
- if an abnormal function of the principal cells is present in essential hypertension, this will become more pronounced at high and low sodium intake.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
-
Holstebro, Denmark, 7500
- Department of Medical Research, Holstebro Hospital
-
-
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:
- Caucasian men and women
- Age 18-65 years
- Arterial hypertension
- Body mass index between 18.5 and 30 kg/m2
Exclusion Criteria:
- Secondary hypertension
- Isolated systolic hypertension
- History or clinical signs of AMI, atrial fibrillation, disease of the heart valves, or chronic heart failure.
- Malignant disease
- Prior apoplexy
- alcohol or drug abuse
- Drug use except antihypertensives and oral contraceptives
- Abnormal biochemical screening of the blood regarding: red and white blood count, s-creatinine (> 200 micromol/L), b-hemoglobin, p-Sodium, p- potassium, 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.
- abnormal electrocardiogram
- Blood donation within one month of the first examination day
- 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.
|
Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
|
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.
|
p-vasopressin
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 |
---|---|
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.
|
u-p-AQP-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.
|
CH2O
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-cAMP
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
May 1, 2009
Study Completion (Actual)
August 1, 2009
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- med.res.hos.2006.cc.02
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.
Clinical Trials on Essential Hypertension and Healthy Controls
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
University of ZurichUnknownGlaucoma Patients and Healthy ControlsSwitzerland
-
University of ZurichCompleted
-
Hospices Civils de LyonCompleted
-
Massachusetts General HospitalCompletedHealthy ControlsUnited States
-
University of North Carolina, Chapel HillNational Institute of Environmental Health Sciences (NIEHS)Terminated
-
University of ZurichTerminatedGlaucoma Patients and Healthy ControlsSwitzerland
-
University of ZurichUnknownGlaucoma Patients and Healthy ControlsSwitzerland
-
Centre for Addiction and Mental HealthUniversity Health Network, TorontoRecruiting
-
ElMindA LtdCompletedHealthy ControlsUnited States
Clinical Trials on Low Sodium Diet
-
Burke Rehabilitation HospitalCompletedStroke | Ischemic StrokeUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Ospedali Riuniti di FoggiaCompleted
-
University of DelawareCompleted
-
Wolfson Medical CenterUnknown
-
Regional Hospital HolstebroCompletedHealthy HumansDenmark
-
Medical College of WisconsinRecruiting
-
University of Sao PauloCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Fundação de Apoio...CompletedHeart Failure; With Decompensation | Heart Failure,CongestiveBrazil
-
Maastricht University Medical CenterCompletedHypertension | Metabolic Syndrome | Insulin Resistance | Abdominal Obesity | Sodium-sensitivityNetherlands
-
DongGuk UniversityBoryung Pharmaceutical Co., LtdCompletedHypertensionKorea, Republic of
-
University of VirginiaNational Heart, Lung, and Blood Institute (NHLBI)Unknown