protocolSection identificationModule nctId: NCT06325800, orgStudyIdInfo id: 2021401/2023007, secondaryIdInfos id: Grant, type: OTHER_GRANT, domain: Juan Rodés Grant (JR23/00018), briefTitle: Glycoxidation, Arterial Biomechanics, and Target Organ Damage, acronym: GlycOxiTod, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Complejo Hospitalario Universitario de Santiago, class: OTHER, collaborators name: Instituto de Investigación Sanitaria de Santiago de Compostela, collaborators name: Instituto de Salud Carlos III, collaborators name: University of Santiago de Compostela, collaborators name: Hospital de Barbanza, descriptionModule briefSummary: 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., conditionsModule conditions: Oxidative Stress, conditions: Cardiovascular Risk, conditions: Target Organ Damage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Assessment of redox status (1), primaryOutcomes measure: Assessment of redox status (2), primaryOutcomes measure: Evaluation of glycation status (1), primaryOutcomes measure: Evaluation of glycation status (2), primaryOutcomes measure: Evaluation of glycation status (3), primaryOutcomes measure: Evaluation of glycation status (4), primaryOutcomes measure: Assessment of Glycoxidation status (1), primaryOutcomes measure: Assessment of Glycoxidation status (2), primaryOutcomes measure: Quantification of arterial targen organ damage (TOD) during the follow-up (1), primaryOutcomes measure: Quantification of arterial targen organ damage (TOD) during the follow-up (2), secondaryOutcomes measure: Evaluation of cardiovascular disease during the follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Complejo Hospitalario Universitario de Santiago de Compostela, status: RECRUITING, city: Santiago De Compostela, state: A Coruña, zip: 15706, country: Spain, contacts name: Nestor Vazquez Agra, PhD, role: CONTACT, phone: 0034981950000, email: nestor.vazquez.agra@sergas.es, contacts name: Nestor Vazquez-Agra, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ana-Teresa Marques-Afonso, MD, role: SUB_INVESTIGATOR, contacts name: Sofia Barbosa-Gouveia, PhD, role: SUB_INVESTIGATOR, contacts name: Anton Cruces-Sande, PhD, role: SUB_INVESTIGATOR, contacts name: Carla Diaz-Louzao, PhD, role: SUB_INVESTIGATOR, contacts name: Iago Carballo, PhD, role: SUB_INVESTIGATOR, contacts name: Lucia Barrera-Lopez, MD, role: SUB_INVESTIGATOR, contacts name: Adela Lama-López, MD, role: SUB_INVESTIGATOR, contacts name: Lucia Gomez-Suarez, MD, role: SUB_INVESTIGATOR, contacts name: Ivan Fernandez-Castro, MD, role: SUB_INVESTIGATOR, contacts name: Clara Casar-Cocheteux, MD, role: SUB_INVESTIGATOR, contacts name: Alvaro Hermida-Ameijeiras, PhD, role: SUB_INVESTIGATOR, contacts name: Arturo Gonzalez-Quintela, PhD, role: SUB_INVESTIGATOR, contacts name: Antonio Pose-Reino, PhD, role: SUB_INVESTIGATOR, contacts name: Francisco Gude-Sampedro, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 42.88052, lon: -8.54569, hasResults: False