Essential Hypertension and Healthy ControlsNCT00345124
The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension
A study testing high sodium diet and Low Sodium Diet in people with Essential Hypertension and Healthy Controls, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension and Healthy Controls
- What is being tested?
- high sodium diet and Low Sodium Diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- May 2006to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian men and women
- Age 18-65 years
- Arterial hypertension
- Body mass index between 18.5 and 30 kg/m2
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medical Research, Holstebro Hospital
Holstebro, 7500
About this study
Official title: 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.
- Being tested
- high sodium diet, Low Sodium Diet
- Keywords
- urinary aquaporin-2, ENaC, fractional sodium excretion, High/low sodium diet
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high sodium dietBehavioural
Also called For four days
250-350 mmol
Low Sodium DietBehavioural
Also called For four days
25-35 mmol
What is being measured
The primary outcome is the main question the study is designed to answer.
u-AQP-2
Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
fractional sodium excretion
Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
p-vasopressin
Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
p-aldosterone
Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Secondary outcomes (6)
u-p-AQP-2
Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
u-ENaC(alfa,beta,gamma)
Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
CH2O
Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
u-cAMP
Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
uPGE2
Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
GFR
Measured: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential Hypertension and Healthy ControlsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Investigators
- Erling B. Pedersen, Professor, Study chair, Department of Medical Research, Holstebro Hospital, DenmarkCarolina C. Graffe, MD, Principal investigator, Department of Medical Research, Holstebro Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345124
- Sponsor's protocol ID
- med.res.hos.2006.cc.02
- Status last verified
- Jun 2011
- First submitted
- 24 Jun 2006
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Graffe CC, Bech JN, Lauridsen TG, Vase H, Pedersen EB. Abnormal increase in urinary aquaporin-2 excretion in response to hypertonic saline in essential hypertension. BMC Nephrol. 2012 Mar 27;13:15. doi: 10.1186/1471-2369-13-15.
PubMed 22452789
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension, During Basal Conditions and After Hypertonic Saline Infusion.
- ClinicalTrials.gov ID
- NCT00345124
- Acronym / sponsor ID
- med.res.hos.2006.cc.02
- Keywords
- urinary aquaporin-2, ENaC, fractional sodium excretion, High/low sodium diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 27 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Caucasian men and women
- Age 18-65 years
- Arterial hypertension
- Body mass index between 18.5 and 30 kg/m2
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high sodium dietAlso: For four days250-350 mmol | Behavioural | – |
| Low Sodium DietAlso: For four days25-35 mmol | Behavioural | – |
Primary outcome
u-AQP-2
Time frame: 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.
p-vasopressin
Time frame: 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.
6 secondary outcomes
u-p-AQP-2
Time frame: 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.
CH2O
Time frame: 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.
uPGE2
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Derived from this study: PubMed 22452789Graffe CC, Bech JN, Lauridsen TG, Vase H, Pedersen EB. Abnormal increase in urinary aquaporin-2 excretion in response to hypertonic saline in essential hypertension. BMC Nephrol. 2012 Mar 27;13:15. doi: 10.1186/1471-2369-13-15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erling B. Pedersen, Professor study chair
Department of Medical Research, Holstebro Hospital, Denmark
Carolina C. Graffe, MD principal investigator
Department of Medical Research, Holstebro Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high sodium diet and Low Sodium Diet in people with Essential Hypertension and Healthy Controls, run by Regional Hospital Holstebro at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
u-AQP-2 (time frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00345124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.