About this trial
The primary research objective of the project is to determine the role of eGC in microvascular reactivity in CKD (cross-sectional study 1).
The main objective of the project is to increase the excellence and interdisciplinarity of scientific work at MEFOS by connecting researchers from different scientific fields, improving conditions and resources for scientific work, and increasing international cooperation, in line with strategic objective 1: raising scientific excellence. The results of the project could provide pathophysiological insight into the development and maintenance of endothelial dysfunction in CKD, as well as identify new biomarkers for CKD.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
patients with CKD of hypertensive etiology (grades 1-2 and 3-5; eGFR CKD-EPI GFR ≥ 90 ml/min/1.73 m², i.e. < 60 mL/min/1.73 m2), non-diabetics, non-smokers
patients with hypertension (according to ESH2023 Guidelines) without kidney damage (eGFR CKD-EPI >90 mL/min/1.73 m2) non-diabetics, non-smokers
healthy volunteer subjects as controls
Disqualifiers
kidney disease of any other etiology except hypertension
endocrine, autoimmune or inflammatory diseases that could affect kidney function.
smoking
diabetes
Trial population
Patients with CKD of hypertensive etiology, patients with hypertension and healthy volunteer subjects as controls.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Microvascular reactivity
Skin microvascular reactivity in patients with chronic kidney disease compared to hypertensive patients and healthy subjects - assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, acetylcholine and sodium nitroprusside)
Endothelial glycocalyx
Measurement of the thickness of eGC in the specified groups - measured by Glycocheck
Secondary outcomes
Endothelial glycocalyx soluble markers
Quantification of soluble markers of eGC from serum or plasma samples in the specified groups - measured by ELISA assays (syndecan-1, syndecan-4, glypican-1, MMP-9)
Concentration of MPO, 8-iso prostaglandin F2a, OxLDL, AOPP and intracellular oxidative stress production
Quantification of oxidative stress biomarkers from serum samples and peripheral blood mononuclear cells (PBMC) in the specified groups - measured by ELISA assays (MPO, 8-iso prostaglandin F2a, OxLDL, AOPP) and flow cytometry (intracellulare oxidative stress production; DCF-DA and DHE)
Macrophage frequency
Quantification of inflammation from peripheral blood mononuclear cells (PBMC) in the specified groups - flow cytometry (macrophage frequency)
Antioxidant enzyme (SOD, CAT, GPx) concentration and activity
Quantification of antioxidative enzyme concentration and activation from serum samples in the specified groups - measured by ELISA assays and UV-Vis spectrophotometry (SOD, GPx, CAT)
Other outcomes
Blood pressure
Automatic oscillometric measurement of systolic and diastolic blood measurement (mmHg)
Heart rate
Automatic oscillometric measurement of heart rate (bpm)
Body Mass Index
Weight and height will be combined to report BMI (kg/m2)
Body composition
Body composition and body fluid status measurement by a four-terminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically derived formulas (the original manufacturer's software) will be used to calculate the estimated Fat Free Mass (FFM kg) and Fat (Fat Mass kg).
Sponsors and contacts
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