Relationship Between Oxidative Stress and Aortic Stiffness
1 other identifier
interventional
43
1 country
2
Brief Summary
The goal of this clinical trial is to search about if there is any relationship between the aortic stiffness and oxidative stress response in adolescent football players. The main questions are;
- Is there any difference between the adolescent football players and healthy sedentary control group in terms of oxidative stress and aortic stiffness parameters?
- Is there any relationship between the aortic stiffness and oxidative response to acute exercise training in adolescent male football players? Participants will perform acute exhaustive exercise training. Venous blood will be drained before and after exercise training. Oxidative parameters will be measured.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2025
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
May 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2025
CompletedAugust 11, 2025
August 1, 2025
1 month
September 4, 2024
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
aortic strain (%)
=\[(aortic systolic diameter - diastolic diameter)× 100\] / aortic diastolic diameter
will be measured twice before and after acute exhaustive exercise, through study completion, up to 8 weeks
aortic stiffness index
= ln (systolic pressure / diastolic pressure) / aortic strain
will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
aortic distensibility (cm2.dyn-1.10-6)
= (2 × aortic strain) / (systolic pressure-diastolic pressure)
will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
serum lipid hydroperoxide assay
lipid hydroperoxide (LHP) level of serum (nmol/mL). Lipid hydroperoxide (LOOH) is the first, comparatively stable, product of the lipid peroxidation reaction.
will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
serum malondialdehide assay
serum malondialdehide (MDA) level of serum (nmol/mL).MDA is the end product of the oxidation of polyunsaturated fatty acids.
will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
serum advanced oxidation protein products assay
Advanced oxidation protein products (AOPP) level of serum (mikromol/L ). AOPP are the dityrosine-containing and crosslinking protein products formed during oxidative stress by reaction of plasma protein with chlorinated oxidants, and often carried by albumin in vivo
will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
serum advanced glycation end products assay
serum advanced glycation end products (AGE) level of serum(FU/mg). AGEs are are a heterogeneous group of proteins and lipids, formed by nonenzymatic glycation after persistent contact with aldose sugars
will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
serum ferric reducing antioxidant power assay
ferric reducing antioxidant power (FRAP) level of serum (mikromol/mL ). FRAP is an antioxidant capacity assay that uses Trolox as a standard
will be measured twice before and after acute exhaustive exercise, through study completion, up to 8 weeks
serum superoxide dismutase activity assay
copper-zinc superoxide dismutase activity (SOD) level of serum (U/mL). SODs are enzymes that catalyze the conversion of naturally-occuring but harmful superoxide radicals into molecular oxygen and hydrogen peroxide
will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
serum total antioxidant status and total oxidant status assay
total antioxidant status (TAS) and total oxidant status (TOS) levels of serum (trolox equivalent/L) are two indicators to determine all antioxidants or oxidants in samples, which can more comprehensively reflect the changes of oxidant and antioxidant capacity of samples
will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
Study Arms (2)
football player
EXPERIMENTAL14-18 years old male football players who play in the infrastructure of a football club
healthy control group
ACTIVE COMPARATOR14-18 years old male healthy participants who don't involve any regular sports training
Interventions
Cardiovascular exercise test will be performed by the participants. This test is sustained until the participants feel exhausted.
Eligibility Criteria
You may qualify if:
- age between 14-18
- male gender
- football player
- attending regular football training for at least 1 season
You may not qualify if:
- female gender
- attending any other sports training except from football
- having any chronic disease
- having any musculoskeletal disease which limits to join exhaustive exercise training
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Istanbul Faculty of Medicine
Istanbul, 34093, Turkey (Türkiye)
Şensu Dinçer
Istanbul, 34093, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Echocardiographer and biochemistry expert will be blind to participants type (sedentary or football player)
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical doctor
Study Record Dates
First Submitted
September 4, 2024
First Posted
September 19, 2024
Study Start
May 30, 2025
Primary Completion
June 30, 2025
Study Completion
July 15, 2025
Last Updated
August 11, 2025
Record last verified: 2025-08