Glycoxidation, Arterial Biomechanics, and Target Organ Damage

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorComplejo Hospitalario Universitario de Santiago

About this trial

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

Qualifiers

Patients aged 18 years or older.

Moderate to high Cardiovascular Risk estimated by SCORE2OP.

Signed written consent for participation in the study.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

500 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Complejo Hospitalario Universitario de Santiago

Lead sponsor

Instituto de Investigación Sanitaria de Santiago de Compostela

Collaborator

Instituto de Salud Carlos III

Collaborator

University of Santiago de Compostela

Collaborator

Hospital de Barbanza

Collaborator