The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension

NCT ID: NCT00345124

Last Updated: 2011-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Essential Hypertension and Healthy Controls

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

high sodium diet

250-350 mmol

Intervention Type BEHAVIORAL

Low Sodium Diet

25-35 mmol

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

For four days For four days

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Regional Hospital Holstebro

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department of Medical Research, Holstebro Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Erling B. Pedersen, Professor

Role: STUDY_CHAIR

Department of Medical Research, Holstebro Hospital, Denmark

Carolina C. Graffe, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Research, Holstebro Hospital, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Medical Research, Holstebro Hospital

Holstebro, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 22452789 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

med.res.hos.2006.cc.02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Human Sodium Balance Study
NCT04110262 COMPLETED NA
Food and Salt Handling in Diuresis
NCT04526340 COMPLETED NA
Potassium Supplementation in CKD
NCT03253172 ACTIVE_NOT_RECRUITING NA