fysiologie van natrium- en volumebalans blood pressure extracellular volume sodium and volume homeostasis sodium buffering capacity of ECL
Conditions
Interventions
All subjects will be asked to adhere to a low and high natrium diet (3 and 12
grams salt daily respectively, which is equal to 50 mmol Na+/d and 200 mmol
Na+/d respectively) for 1 week each in rando
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy subjects - Male between 18 and 40 years of age - Healthy, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination (PE) and laboratory tests carried out in the screening visit. - Non-treated office blood pressure * 140/90 mmHg - Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form
Exclusion criteria
Exclusion criteria: - An office blood pressure >140/90 mmHg - A body mass index > 30 kg/m2 - A major illness in the past 3 months or any significant chronic medical illness that the Investigator would deem unfavourable for enrolment, including chronic inflammatory diseases - A history of any type of malignancy within the past 5 years with the exception of successfully treated basal cell cancer of the skin - A history of any renal disease - A history of cardiovascular disease (in the past 6 months) defined as documented coronary artery disease including myocardial infarction, (un-)stable angina pectoris or acute coronary syndrome, precutenaous transluminal coronary angioplasty, coronary artery bypass grafting, cerebrovascular disease including ischemic and hemorrhagic stroke or a subarachnodial bleeding, or peripheral artery disease including aortic aneurysmata - A history of coagulation disorders - A history of primary hyperlipoproteinemias - A history of hypersensitivity or allergy to iodium or to shell fish - A history, within 3 years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, THC, methamphetamine) - A history of alcoholism and/or is drinking more than 3 units of alcohol per day. Alcoholism is defined as an average weekly intake of >21 units for males. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits - Difficulty in donating blood or limited accessibility of a vein in left and right arm - Subject has donated blood in last 3 months - Use of tobacco products - Any other issue that, in the opinion of the Investigator, could be harmful to the subject or compromise interpretation of the data - Prior participation in a trial where the subject received intravenous endotoxin (LPS) infusion - Any clinically relevant abnormality noted on the 12-lead ECG as judged by the Investigator or an average QTcB or QTcF > 450 millisec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will study primarily the effects of a salt load on the haemodynamics and ECV in subjects with a presumed normal ESL in healthy subjects. Primary endpoint will be the ECV as represented by body weight and BP. Furthermore, the golden standard for ECV measurement will be performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other study paramaters consist of indirect measurements of the ESL dynamics and function as assessed with intravital microscopy of the sublingual microvasculature and transcapillary escape rate (TER). We will study the kidney function as represented by the glomerular filtration rate (GFR), fractional Na+ excretion, albuminuria and proteinuria. Finally, skin biopsies will allow study of the role of interstitial GAGs and macrophage influx in response to a salt load. | — |
Countries
Netherlands
Outcome results
None listed