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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05109013
Other study ID # 2158-61-07-21-06
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date December 31, 2023

Study information

Verified date November 2021
Source Josip Juraj Strossmayer University of Osijek
Contact Martina Kos, MD
Phone +385981748381
Email mkatic983@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main goal of this study is to investigate the association of the juvenile essential arterial hypertension with systemic micro- and macrovascular reactivity and cerebral vascular function, and to examine the potential impact of elevated oxidative stress on this associations.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 18 Years
Eligibility Inclusion Criteria: - healthy normotensive children and children with essential arterial hypertension Exclusion Criteria: - secondary arterial hypertension - other systemic diseases with immunopathology - neurodegenerative diseasesat - children that use therapy which has a high impact on vascular or immunological function (immunotherapy, immunosuppressive therapy, sistemic corticosteroid therapy etc..).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Croatia Osijek University Hospital Osijek

Sponsors (1)

Lead Sponsor Collaborator
Josip Juraj Strossmayer University of Osijek

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Other Blood pressure Automatic oscillometric measurement of blood pressure (in mmHg) Day 1.
Other Heart rate Automatic oscillometric measurement of heart rate (bpm) Day 1.
Other Body mass index Measurement of body weight (kg) and body height (cm) from which will be combined to report body mass index (BMI) using formula: weight (kg) / [height (m)]2 (kg/m2) Day 1.
Other Body composition - Fat Free Mass estimation Body composition status measured by a fourterminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically dervide formulas (the original manufacturer's software) will be used to calculate the estimated Fat Free Mass (FFM kg) Day 1.
Other Body composition - Fat estimation Body composition status measured by a fourterminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically dervide formulas (the original manufacturer's software) will be used to calculate the estimated Fat (Fat Mass kg) Day 1.
Other Body fluid status 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 Total Body Water (TBW L), Extracellular Water (ECW L), Intracellular Water (ICW L), Plasma Fluid (PF L) and Interstitial Fluid (IF L). Day 1.
Primary Systemic microvascular function in children Skin microvascular reactivity assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside) - measured in perfusion units (PU) Day 1.
Primary Systemic macrovascular function in children Vascular ultrasound measurement of brachial artery response to vascular occlusion (flow mediated dilation; FMD, %) Day 1.
Primary Cerabral vascular function in children Cerebral blood flow velocities assessed by transcranial Doppler sonography (cm/s) Day 1.
Secondary Oxidative stress - thiobarbituric acid reactive substances (TBARS) Serum sample collection for measurement of biomarkers of oxidative stress level. Thiobarbituric acid reactive substances (TBARS) - biomarker of lipid peroxidation. Day 1.
Secondary Endocan Serum sample collection for ELISA measurement of serum endocan level - proteoglycan associated with endothelium activation Day 1.
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