The effect of sodium nitrite on kidney salt and water regulation, blood pressure regulating hormones and blood pressure in healthy subjects during inhibition of various enzyme systems.
- Conditions
- The normal physiological responses in healthy subjectsMedDRA version: 14.1Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - InvestigationsTherapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Registration Number
- EUCTR2013-003404-39-DK
- Lead Sponsor
- Department of Medical Research, Regional Hospital Holstebro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Age 18-40 years, BMI 18,5-30, women must use contraception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Tobacco smoking, medicin or substance abuse, Weekly consumption of more than 21 standard drinks of alcohol for men and 14 standard drinks of alcohol for women (1 danish standard drink equals 12 grams of alcohol), medical treatment in the last 2 weeks except for contraception, pregnancy or nursing, diabetes mellitus, eGFR < 60 ml/min, neoplasm, clinically significant heart, lung, liver, kidney, metabolic or neurologic disorder, clinically significant findings in screening blood samples, urine sample or ECG, office blood pressure > 140/90 mmHg, donation of blood within 1 month of the first day of investigation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate how inhibition of xanthine oxidase, angiotensine converting enzyme and carbonic anhydrase affects the response to sodium nitrite infusion in healthy subjects;Secondary Objective: Not applicable;Primary end point(s): Fractional sodium excretion (FENa);Timepoint(s) of evaluation of this end point: Subjects will be followed with repeated blood samples for the duration of the examination day, from 8 AM to 2 PM.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Subjects will be followed with repeated measurements, blood and urine samples for the duration of the examination day, from 8 AM to 2 PM.;Secondary end point(s): Brachial blood pressure and central aortic systolic blood pressure Glomerular filtration rate<br>Absolute sodium excretion and proximal tubular sodium transport (lithium clearance)<br>Plasma levels of renin, angiotensin 2, aldosteron, atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), cGMP, endothelin and vasopressin<br>Urinary excretion of aquaporin 2, ENaC, c-AMP, NKCC2 <br>Renal clearance of nitrate and nitrite<br>Free water clearance