Glycocalyx and Oxidative Stress in Endothelial Function (Part 1)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Role of Glycocalyx and Oxidative Stress in Endothelial Function (Part 1)
Overview
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.
Primary outcome measures
- Microvascular reactivity [Time frame: Baseline, at one time point (first visit to the laboratory)]
- Endothelial glycocalyx [Time frame: Baseline, at one time point (first visit to the laboratory)]
Secondary outcome measures (4)
- Endothelial glycocalyx soluble markers [Time frame: Baseline, at one time point (first visit to the laboratory)]
- 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)]
- Macrophage frequency [Time frame: Baseline, at one time point (first visit to the laboratory)]
- Antioxidant enzyme (SOD, CAT, GPx) concentration and activity [Time frame: Baseline, at one time point (first visit to the laboratory)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Croatia · 1 center
- Osijek University Hospital — Osijek
Identifiers
NCT: NCT07437729 · 602-04/25-08/07