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