The Effect of Thiazide, Amiloride and Hypertonic Saline on Urinary Biomarkers in Healthy Subjects
NCT ID: NCT01635231
Last Updated: 2014-03-04
Study Results
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Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2012-07-31
2013-11-30
Brief Summary
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Changes in the sodium-and water channel activity can be induced by blocking the sodium channels with diuretics in healthy subjects
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Detailed Description
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2. Changes in the sodium-and water channel activity is induced by blocking the NCC channels with thiazide and ENaC channels with amiloride and by intervention with hypertonic NaCl The changes in sodium-and water channels are followed by changes in extracellular and intracellular fluids, central bloodpressure and the plasma concentration of vasoactive hormones.
The purpose of this study is to investigate the changes in urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2), extra- and intracellular fluid compartments, central bloodpressure and the plasma concentration of Vasoactive hormones in healthy subjects under a) treatment with Amiloride and Thiazide at baseline and b) after and acute infusion with hypertonic saline.
Subjects will be examined on three examination days. Four days prior to the examination days the subjects will consume a standard diet based on amount of sodium and calories and randomized to treatment with either thiazide, amiloride or placebo twice daily for 5 days. On the examination days the subjects receive an infusion with hypertonic saline.
Renal function is measured by renal clearance of 51Cr-EDTA. Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) will be measured to evaluate the activity of water- and sodium channels in the nephron, changes in fluid compartments are measured by body composition monitor. Central blood pressure is measured by sphygmocor.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
TRIPLE
Study Groups
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thiazide, diuretic
1.25 mg thiazide twice daily for 5 days
hypertonic saline
hypertonic saline 3.0% 7 ml/kg
amiloride, diuretic
5 mg of amiloride twice daily
hypertonic saline
hypertonic saline 3.0% 7 ml/kg
calcium
placebo twice daily for 5 days
hypertonic saline
hypertonic saline 3.0% 7 ml/kg
Interventions
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hypertonic saline
hypertonic saline 3.0% 7 ml/kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 18-45
* BMI range 18,5-30,0 kg/m2
Exclusion Criteria
* history or clinical significant signs of heart, lung, liver, kidney, endocrine, brain or neoplastic
* disease.
* alcohol abuse
* drug abuse
* smoking
* pregnancy or nursing
* blood donation within a month prior to examination
* medical treatment apart from oral contraception abnormal blood samples, -ECG and -urine dipstick, drug abuse, alcohol abuse, pregnancy, medication
18 Years
45 Years
ALL
Yes
Sponsors
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Regional Hospital Holstebro
OTHER
Responsible Party
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Erling Bjerregaard Pedersen
Ph.d student Janni Majgaard Jensen
Principal Investigators
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Erling B Pedersen, MD, DMSc
Role: STUDY_DIRECTOR
Medical Research, Holstebro
Locations
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Medical Research
Holstebro, , Denmark
Countries
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Other Identifiers
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EBP-JMJ-2012-1
Identifier Type: -
Identifier Source: org_study_id
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