fysiologie van natrium- en volumebalans blood pressure extracellular volume sodium and volume homeostasis sodium buffering capacity of ESL
Conditions
Interventions
High salt diet (>200 mmol Na+ daily) for 1 week, and low salt diet (
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diabetic patients (n 60 ml/min and 60 ml/min and
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 - 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 primarily study the effects of a salt load on the haemodynamics, ECV and ESL in patients with acquired and congenital loss of the ESL. Primary endpoint will be the ECV as represented by body weight, BP and iohexol measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other study paramaters consist of indirect measurements of the ESL dynamics and function assessed by imaging of the sublingual microvasculature, measurement of ESL shedding products and determination of the transcapillary escape rate (TER) of I125-albumine. The kidney function will be studied by estimating the glomerular filtration rate (eGFR) and measurement of the fractional Na+ excretion and albuminuria. Finally, skin biopsies will allow studying the role of interstitial GAGs and macrophage influx in response to a salt load. | — |
Countries
Netherlands
Outcome results
None listed