The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers in Healthy Young Subjects

Study Overview
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Brief Summary
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The kidneys have numerous salt and water channels and play a major role in the regulation of sodium and water. We do not know how these channels work in certain water and sodium accumulating medical conditions. The purpose of this study is to identify and measure the activity in the water and sodium channels by measuring urine biomarkers/proteins in young healthy subjects.

Detailed Description
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25 healthy subjects from age 18-45 are recruited. Subjects will be examined on three examination days. Four days prior to the examination days the subjects will consume a standard diet based on the amount of sodium and calories. On the examination day subjects are randomised to an infusion with either isotonic saline 23 ml/kg, hypertonic saline 7 ml/kg or glucose 23 ml/kg for a period of 50 minutes. Renal function is measured by renal clearance of 51Cr-EDTA, urinary sodium, potassium and creatinine. Urinary NCC, NKCC and ENAC will be measured to evaluate the activity of sodium channels in the nephron.

Official Title
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The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers for the Measurement of Sodium and Water Channel Activity in the Nephron in Healthy Young Subjects

Conditions
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Nephropathy

Intervention / Treatment
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* Other: isotonic saline 0,9 mg/ml
* Other: hypertonic saline 2,9 mg/ml
* Other: glucose 5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy males and females age 18-45 BMI range 18,5-30,0 kg/m2 Exclusion Criteria: hypertension (ie ambulatory BP >130 mmHg systolic or/and >80 mmHg diastolic) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: glucose<br>glucose 5 % | Other: glucose 5%<br>* infusion, 23 ml/kg, during 50 minutes<br>* Other names: glucose 5 %;|
| Active Comparator: isotonic saline<br>isotonic saline 0.9 mg/ml | Other: isotonic saline 0,9 mg/ml<br>* infusion, 23 ml/kg, during 50 minutes<br>* Other names: isotonic saline;|
| Active Comparator: hypertonic saline<br>hypertonic saline 2.9 mg/ml | Other: hypertonic saline 2,9 mg/ml<br>* infusion, 7 ml/kg, during 50 minutes<br>* Other names: hypertonic saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal biomarkers | Urinary epithelial sodium channels (ENaC), Sodium-Chloride transporters (NCC), Sodium-potassium-2chloride transporters (NKCC) and aquaporin2 channels (AQP2) before, during and after fluid infusion | day one | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood hormones regulating salt, water and blood pressure | plasma concentrations of: renin, Angiotensin II, Vasopressin, atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) | day one | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NCC, Nephrology, ENaC, NKCC, Sodium channels, renal biomarkers