NCT06325800 Glycoxidation, Arterial Biomechanics, and Target Organ Damage
| NCT ID | NCT06325800 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Complejo Hospitalario Universitario de Santiago |
| Condition | Oxidative Stress |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-01-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Vascular target organ damage (TOD), defined as structural or functional deleterious changes in large and small arteries, is related to unfavorable arterial biomechanics, atherosclerosis and arteriosclerosis. Endothelial dysfunction due to unfavorable redox and glycation states on the bases of these phenomena. However, little is known about the role of glycoxidation on arterial biomechanics and TOD in apparently healthy individuals. The main hypothesis is that glycation and glycoxidation status are associated with arterial biomechanical abnormalities and TOD in patients with moderate to high cardiovascular risk. This is an observational, ambispective, and multicenter project that will include non-smoking patients over 18 years, without diabetes mellitus or established cardiovascular disease. Demographic, epidemiological, and clinical-anthropometric variables will be collected, including data from ambulatory blood pressure monitoring. The investigators will measure the serum percentage of glycated hemoglobin, glycated albumin, and fructosamine levels; along with quantification of skin advanced glycation and glycoxidation end productos (AGEs). Plasma concentration, activity, and structure of catalase, glutathione peroxidase, and superoxide dismutase in relation to the patient's glycation and glycoxidation status will be also evaluated. Concurrently, several biomechanical parameters will be assessed in the Common, Internal Carotid Artery, and distal limb arteries using ultrasound exploration. Incipient microvasculature damage will be also evaluated by retinal image. Patients will be followed up for the development of arterial biomechanical abnormalities and TOD, along with cardiovascular events.
Eligibility Criteria
Inclusion Criteria: * Patients aged 18 years or older. * Moderate to high Cardiovascular Risk estimated by SCORE2OP. * Signed written consent for participation in the study. Exclusion Criteria: * Absence of current smoking habit and in the last 6 months. * High-risk alcohol consumption (More than 10 and 20 g/day in women and men, respectively). * Presence of Diabetes mellitus. * Established cardiovascular disease, including heart failure, ischemic heart disease, valvular heart disease, atrial fibrillation, peripheral artery disease, and cerebrovascular disease.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06325800 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oxidative Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06325800 currently recruiting?
Yes, NCT06325800 is actively recruiting participants. Contact the research team at nestor.vazquez.agra@sergas.es for enrollment information.
Where is the NCT06325800 trial being conducted?
This trial is being conducted at Santiago de Compostela, Spain.
Who is sponsoring the NCT06325800 clinical trial?
NCT06325800 is sponsored by Complejo Hospitalario Universitario de Santiago. The trial plans to enroll 500 participants.