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NCT Number: NCT07437729

Glycocalyx and Oxidative Stress in Endothelial Function (Part 1)

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.

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Key information

Conditions

Chronic Kidney Disease Patients Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Osijek University Hospital

Osijek, 31000, Croatia

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Microvascular reactivity

    Time frame: Baseline, 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)

  2. Endothelial glycocalyx

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

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

Secondary outcomes

  1. Endothelial glycocalyx soluble markers

    Time frame: Baseline, 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)

  2. Concentration of MPO, 8-iso prostaglandin F2a, OxLDL, AOPP and intracellular oxidative stress production

    Time frame: Baseline, 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)

  3. Macrophage frequency

    Time frame: Baseline, 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)

  4. Antioxidant enzyme (SOD, CAT, GPx) concentration and activity

    Time frame: Baseline, 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)

Other outcomes

  1. Blood pressure

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

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

  2. Heart rate

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

    Automatic oscillometric measurement of heart rate (bpm)

  3. Body Mass Index

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

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

  4. Body composition

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

    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).

  5. Body fluid status: Estimation of Total Body Water (TBW L), Extracellular Water (ECW L), Intracellular Water (ICW L), Plasma Fluid (PF L) and Interstitial Fluid (IF L)

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

    Body fluid status measurement by four-terminal portable impedance analyzer. A single impedance measurement is used to derive Total Body Water (TBW), Extracellular Water (ECW), Intracellular Water (ICW), Plasma Fluid (PF), and Interstitial Fluid (IF) using the manufacturer's software.

Study contacts

Contact information is provided by the study sponsor or research team.

Ines Drenjančević, MD, PhD

CONTACT

[email protected]

+385912241406

Sponsors and collaborators

Lead sponsor

Josip Juraj Strossmayer University of Osijek

Other

Registry information

Official study title

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

Acronym: GlikoOxEND

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 27, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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