Glycocalyx and Oxidative Stress in Endothelial Function (Part 1)

NCT07437729 | Recruiting

• 1 other identifier: 602-04/25-08/07
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease Patients

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

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

• Endothelial glycocalyx

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

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

Secondary Outcomes (4)

• Endothelial glycocalyx soluble markers

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

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

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

• Macrophage frequency

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

• Antioxidant enzyme (SOD, CAT, GPx) concentration and activity

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

Other Outcomes (5)

• Blood pressure

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

• Heart rate

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

• Body Mass Index

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

Study Arms (3)

Chronic Kidney Disease (CKD) group

Patients with CKD of hypertensive etiology, stages 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

Hypertension (HT) group

Patients who have hypertension (according to ESH2023 Guidelines doi: 10.1097/HJH.0000000000003480) without kidney damage (eGFR CKD-EPI \>90 mL/min/1.73 m2) non-diabetics, non-smokers

Normotensive (NT) group

Healthy volunteer subjects as controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with CKD of hypertensive etiology, patients with hypertension and healthy volunteer subjects as controls.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek: lead

Study Sites (1)

Osijek University Hospital

Osijek, 31000, Croatia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, peripheral blood mononuclear cells (PBMC)

MeSH Terms

Conditions

Inflammation; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Ines Drenjančević, MD, PhD

  Faculty of Medicine Josip Juraj Strossmayer University of Osijek

  STUDY CHAIR

Central Study Contacts

Ines Drenjančević, MD, PhD

CONTACT

+385912241406; ines.drenjancevic@mefos.hr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Physiology and Immunology Faculty of Medicine Osijek

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 27, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: March 2, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)