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

NCT ID: NCT00345215

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Healthy Humans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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High Sodium Diet

250-350 mmol

Intervention Type BEHAVIORAL

Low Sodium Diet

25-35 mmol

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regional Hospital Holstebro

OTHER

Sponsor Role lead

Responsible Party

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Department of Medical Research, Holstebro Hospital

Principal Investigators

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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

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Department of Medical Research, Holstebro Hospital

Holstebro, Holstebro, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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med.res.hos.2006.cc.01

Identifier Type: -

Identifier Source: org_study_id

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