Glycocalyx and Oxidative Stress in Endothelial Function (Part 1)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJosip Juraj Strossmayer University of Osijek

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

105 Participants
are grouped into 3 trial groups
Group A: Chronic Kidney Disease (CKD) group
Group B: Hypertension (HT) group
Group C: Normotensive (NT) group

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline, at one time point (first visit to the laboratory)
2

Endothelial glycocalyx

Measurement of the thickness of eGC in the specified groups - measured by Glycocheck

Time frame
Baseline, at one time point (first visit to the laboratory)

Secondary outcomes

1

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)

Time frame
Baseline, at one time point (first visit to the laboratory)
2

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)

Time frame
Baseline, at one time point (first visit to the laboratory)
3

Macrophage frequency

Quantification of inflammation from peripheral blood mononuclear cells (PBMC) in the specified groups - flow cytometry (macrophage frequency)

Time frame
Baseline, at one time point (first visit to the laboratory)
4

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)

Time frame
Baseline, at one time point (first visit to the laboratory)

Other outcomes

1

Blood pressure

Automatic oscillometric measurement of systolic and diastolic blood measurement (mmHg)

Time frame
Baseline, at one time point (first visit to the laboratory)
2

Heart rate

Automatic oscillometric measurement of heart rate (bpm)

Time frame
Baseline, at one time point (first visit to the laboratory)
3

Body Mass Index

Weight and height will be combined to report BMI (kg/m2)

Time frame
Baseline, at one time point (first visit to the laboratory)
4

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).

Time frame
Baseline, at one time point (first visit to the laboratory)

Sponsors and contacts

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