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Glycocalyx and Oxidative Stress in Endothelial Function (Part 1)

The Role of Glycocalyx and Oxidative Stress in Endothelial Function (Part 1)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07437729
Acronym
GlikoOxEND
Enrollment
105
Registered
2026-02-27
Start date
2025-10-01
Completion date
2029-09-30
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease Patients

Keywords

Glycocalyx, Microcirculation, Endothelium, Inflammation, Oxidative Stress, Renal Insufficiency, Chronic

Brief summary

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.

Detailed description

The primary objective of this project is to determine the role of endothelial glycocalyx (eGC) in impaired microvascular endothelium-dependent reactivity in patients with chronic kidney disease compared to healthy and hypertensive patients without complications (cross-sectional study 1). Specific objective 1.1: Measure the reactivity of the peripheral microcirculation (using a laser Doppler blood flow meter) and the thickness of eGC (using Glycocheck) in the specified groups. Specific objective 1.2: Quantify soluble markers of eGC, oxidative stress, and inflammation from serum samples and peripheral blood mononuclear cells (PBMC), as well as antioxidant capacity in the specified groups. Specific objective 1.3: Determine the relationship between the results of functional tests, eGC, and markers from specific objective 1.2.

Interventions

None listed

Sponsors

Josip Juraj Strossmayer University of Osijek
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* kidney disease of any other etiology except hypertension * endocrine, autoimmune or inflammatory diseases that could affect kidney function. * smoking * diabetes

Design outcomes

Primary

MeasureTime frameDescription
Microvascular reactivityBaseline, at one time point (first visit to the laboratory)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 glycocalyxBaseline, at one time point (first visit to the laboratory)Measurement of the thickness of eGC in the specified groups - measured by Glycocheck

Secondary

MeasureTime frameDescription
Endothelial glycocalyx soluble markersBaseline, at one time point (first visit to the laboratory)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 productionBaseline, at one time point (first visit to the laboratory)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 frequencyBaseline, at one time point (first visit to the laboratory)Quantification of inflammation from peripheral blood mononuclear cells (PBMC) in the specified groups - flow cytometry (macrophage frequency)
Antioxidant enzyme (SOD, CAT, GPx) concentration and activityBaseline, at one time point (first visit to the laboratory)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)

Countries

Croatia

Contacts

CONTACTInes Drenjančević, MD, PhD
ines.drenjancevic@mefos.hr+385912241406
STUDY_CHAIRInes Drenjančević, MD, PhD

Faculty of Medicine Josip Juraj Strossmayer University of Osijek

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026