Last reviewed · How we verify
NCT06325800: GlycOxiTod
Glycoxidation, Arterial Biomechanics, and Target Organ Damage
trial in Oxidative Stress in 500 participants. Currently enrolling.
31 December 2024
Quick facts
| Lead sponsor | Complejo Hospitalario Universitario de Santiago |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 1 January 2024 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2029 |
| Sites | 1 location across Spain |
Conditions studied
- Oxidative Stress — all drugs for Oxidative Stress →
- Cardiovascular Risk — all drugs for Cardiovascular Risk →
- Target Organ Damage — all drugs for Target Organ Damage →
Sponsor
Complejo Hospitalario Universitario de Santiago
Who can join
18 and older, any sex, with Oxidative Stress or Cardiovascular Risk. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06325800
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06325800 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Complejo Hospitalario Universitario de Santiago
- Last refreshed: 9 April 2024
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing