SALT-2 study: Role of endothelial surface layer in regulating the sodium balance and extracellular fluid volume
Recruiting
- Conditions
- endothelial surface layersodiumextracellular volumeblood pressure
- Registration Number
- NL-OMON28711
- Lead Sponsor
- Academic Medical Center, Amsterdam
- Brief Summary
none
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1. Diabetic patients (n=12)
- Male between 18 and 40 years old
Exclusion Criteria
- An office blood pressure >140/90 mmHg
- A body mass index > 30 kg/m2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.