Oxidative Stress Clinical Trial
— GlycOxiTodOfficial title:
The Role of Glycoxidation on Arterial Biomechanics and Target Organ Damage in Patients With Moderate to High Cardiovascular Risk. The GlycOxiTod Observational Multicentric Registry
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2029 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Hospitalario Universitario de Santiago de Compostela | Santiago De Compostela | A Coruña |
Lead Sponsor | Collaborator |
---|---|
Complejo Hospitalario Universitario de Santiago | Hospital de Barbanza, Instituto de Investigación Sanitaria de Santiago de Compostela, Instituto de Salud Carlos III, University of Santiago de Compostela |
Spain,
Aebi H. Catalase in vitro. Methods Enzymol. 1984;105:121-6. doi: 10.1016/s0076-6879(84)05016-3. No abstract available. — View Citation
Al-Kuraishy HM, Sami OM, Hussain NR, Al-Gareeb AI. Metformin and/or vildagliptin mitigate type II diabetes mellitus induced-oxidative stress: The intriguing effect. J Adv Pharm Technol Res. 2020 Jul-Sep;11(3):142-147. doi: 10.4103/japtr.JAPTR_18_20. Epub 2020 Jul 14. — View Citation
Amos A, Greaves L, Nichter M, Bloch M. Women and tobacco: a call for including gender in tobacco control research, policy and practice. Tob Control. 2012 Mar;21(2):236-43. doi: 10.1136/tobaccocontrol-2011-050280. Epub 2011 Dec 13. — View Citation
Andrikou I, Tsioufis C, Konstantinidis D, Kasiakogias A, Dimitriadis K, Leontsinis I, Andrikou E, Sanidas E, Kallikazaros I, Tousoulis D. Renal resistive index in hypertensive patients. J Clin Hypertens (Greenwich). 2018 Dec;20(12):1739-1744. doi: 10.1111 — View Citation
Atzeni IM, van de Zande SC, Westra J, Zwerver J, Smit AJ, Mulder DJ. The AGE Reader: A non-invasive method to assess long-term tissue damage. Methods. 2022 Jul;203:533-541. doi: 10.1016/j.ymeth.2021.02.016. Epub 2021 Feb 23. — View Citation
Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333. — View Citation
Bozkurt Yilmaz HE, Yilmaz M. Assessment of Carotid Artery Distensibility and Elasticity in Patients with Asthma. Iran J Allergy Asthma Immunol. 2021 Jun 6;20(3):279-286. doi: 10.18502/ijaai.v20i3.6329. — View Citation
Briasoulis A, Agarwal V, Messerli FH. Alcohol consumption and the risk of hypertension in men and women: a systematic review and meta-analysis. J Clin Hypertens (Greenwich). 2012 Nov;14(11):792-8. doi: 10.1111/jch.12008. Epub 2012 Sep 25. — View Citation
Chaila MZ, Viniegra M, Gagliardino JJ, Martinez A, Simesen de Bielke MG, Frusti M, Monaco L, Salgado P, Buso C, Gonzalez CD, Commendatore VF. Glycated Hemoglobin Measurement: Comparison of Three Methods Versus High Performance Liquid Chromatography. J Dia — View Citation
Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. New York: Routledge; 1988. https://doi.org/10.4324/9780203771587.
Diaz-Louzao C, Barrera-Lopez L, Lopez-Rodriguez M, Casar C, Vazquez-Agra N, Pernas-Pardavila H, Marques-Afonso A, Vidal-Vazquez M, Montoya JG, Andrade AH, Fernandez-Castro I, Varela P, Gonzalez-Quintela A, Otero E, Gude F, Cadarso-Suarez C, Tome S. Longitudinal relationship of liver injury with inflammation biomarkers in COVID-19 hospitalized patients using a joint modeling approach. Sci Rep. 2022 Apr 1;12(1):5547. doi: 10.1038/s41598-022-09290-x. — View Citation
ELLMAN GL. Tissue sulfhydryl groups. Arch Biochem Biophys. 1959 May;82(1):70-7. doi: 10.1016/0003-9861(59)90090-6. No abstract available. — View Citation
ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S19-S40. doi: 10.2337/dc23-S002. Erratum In: Diabetes Care. 2023 Feb 01;: Diabetes Care. 2023 Sep 1;46(9):1715. — View Citation
Flohe L, Gunzler WA. Assays of glutathione peroxidase. Methods Enzymol. 1984;105:114-21. doi: 10.1016/s0076-6879(84)05015-1. No abstract available. — View Citation
Gianazza E, Brioschi M, Fernandez AM, Banfi C. Lipoxidation in cardiovascular diseases. Redox Biol. 2019 May;23:101119. doi: 10.1016/j.redox.2019.101119. Epub 2019 Feb 25. — View Citation
Guzik TJ, Touyz RM. Oxidative Stress, Inflammation, and Vascular Aging in Hypertension. Hypertension. 2017 Oct;70(4):660-667. doi: 10.1161/HYPERTENSIONAHA.117.07802. Epub 2017 Aug 7. No abstract available. — View Citation
Hoelzel W, Weykamp C, Jeppsson JO, Miedema K, Barr JR, Goodall I, Hoshino T, John WG, Kobold U, Little R, Mosca A, Mauri P, Paroni R, Susanto F, Takei I, Thienpont L, Umemoto M, Wiedmeyer HM; IFCC Working Group on HbA1c Standardization. IFCC reference sys — View Citation
Hospital Clínico Universitario de Santiago - Área Sanitaria de Santiago de Compostela y Barbanza (Hospitales, Centros de Salud, Casas del Mar y Consultorios) n.d. https://xxisantiago.sergas.es/Paxinas/web.aspx? tipo=paxtab&idLista=3&idContido=183&migtab=174%3B183&idioma=es (accessed March 12, 2024).
Ji H, Xiong J, Yu S, Chi C, Bai B, Teliewubai J, Lu Y, Zhang Y, Xu Y. Measuring the Carotid to Femoral Pulse Wave Velocity (Cf-PWV) to Evaluate Arterial Stiffness. J Vis Exp. 2018 May 3;(135):57083. doi: 10.3791/57083. — View Citation
Kwas M, Bucholc B, Slusarczyk J. [Use of electrophoresis in polyacrylomide gel (SDS_PAGE) for evaluating IgG structure--the main component of human intravenous immunoglobulin]. Med Dosw Mikrobiol. 2000;52(3):301-9. Polish. — View Citation
Malone HE, Nicholl H, Coyne I. Fundamentals of estimating sample size. Nurse Res. 2016 May;23(5):21-5. doi: 10.7748/nr.23.5.21.s5. — View Citation
Mattson MP. Roles of the lipid peroxidation product 4-hydroxynonenal in obesity, the metabolic syndrome, and associated vascular and neurodegenerative disorders. Exp Gerontol. 2009 Oct;44(10):625-33. doi: 10.1016/j.exger.2009.07.003. Epub 2009 Jul 19. — View Citation
Molinari F, Zeng G, Suri JS. A state of the art review on intima-media thickness (IMT) measurement and wall segmentation techniques for carotid ultrasound. Comput Methods Programs Biomed. 2010 Dec;100(3):201-21. doi: 10.1016/j.cmpb.2010.04.007. Epub 2010 — View Citation
Ohkawa H, Ohishi N, Yagi K. Assay for lipid peroxides in animal tissues by thiobarbituric acid reaction. Anal Biochem. 1979 Jun;95(2):351-8. doi: 10.1016/0003-2697(79)90738-3. No abstract available. — View Citation
Piskorz D. Hypertensive Mediated Organ Damage and Hypertension Management. How to Assess Beneficial Effects of Antihypertensive Treatments? High Blood Press Cardiovasc Prev. 2020 Feb;27(1):9-17. doi: 10.1007/s40292-020-00361-6. Epub 2020 Jan 23. — View Citation
Sigrist RMS, Liau J, Kaffas AE, Chammas MC, Willmann JK. Ultrasound Elastography: Review of Techniques and Clinical Applications. Theranostics. 2017 Mar 7;7(5):1303-1329. doi: 10.7150/thno.18650. eCollection 2017. — View Citation
Simon BR, Kaufmann MV, McAfee MA, Baldwin AL. Finite element models for arterial wall mechanics. J Biomech Eng. 1993 Nov;115(4B):489-96. doi: 10.1115/1.2895529. — View Citation
Strandberg TE, Pitkala K. What is the most important component of blood pressure: systolic, diastolic or pulse pressure? Curr Opin Nephrol Hypertens. 2003 May;12(3):293-7. doi: 10.1097/00041552-200305000-00011. — View Citation
van Schaick G, Pot S, Schouten O, den Hartog J, Akeroyd M, van der Hoeven R, Bijleveld W, Abello N, Wuhrer M, Olsthoorn M, Dominguez-Vega E. Evaluating the effect of glycation on lipase activity using boronate affinity chromatography and mass spectrometry — View Citation
Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available. Erratum In: Eur Heart J. 2022 Nov 7;43(42):4468. — View Citation
Vistoli G, De Maddis D, Cipak A, Zarkovic N, Carini M, Aldini G. Advanced glycoxidation and lipoxidation end products (AGEs and ALEs): an overview of their mechanisms of formation. Free Radic Res. 2013 Aug;47 Suppl 1:3-27. doi: 10.3109/10715762.2013.815348. — View Citation
Wang MC, Lloyd-Jones DM. Cardiovascular Risk Assessment in Hypertensive Patients. Am J Hypertens. 2021 Jun 22;34(6):569-577. doi: 10.1093/ajh/hpab021. — View Citation
Wolff G, Lin Y, Akbulut C, Brockmeyer M, Parco C, Hoss A, Sokolowski A, Westenfeld R, Kelm M, Roden M, Schlesinger S, Kuss O. Meta-analysed numbers needed to treat of novel antidiabetic drugs for cardiovascular outcomes. ESC Heart Fail. 2023 Feb;10(1):552 — View Citation
Wu WC, Ma WY, Wei JN, Yu TY, Lin MS, Shih SR, Hua CH, Liao YJ, Chuang LM, Li HY. Serum Glycated Albumin to Guide the Diagnosis of Diabetes Mellitus. PLoS One. 2016 Jan 14;11(1):e0146780. doi: 10.1371/journal.pone.0146780. eCollection 2016. — View Citation
Zwakenberg SR, de Jong PA, Hendriks EJ, Westerink J, Spiering W, de Borst GJ, Cramer MJ, Bartstra JW, Doesburg T, Rutters F, van der Heijden AA, Schalkwijk C, Schurgers LJ, van der Schouw YT, Beulens JWJ; SMART Study Group. Intimal and medial calcificatio — View Citation
* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of redox status (1) | Evaluation of thiobarbituric acid reactive substances (TBARS) levels as a measure of lipid peroxidation | Present, two, four years and final (5 years) | |
Primary | Assessment of redox status (2) | Evaluation of reduced thiol levels as a measure of protein oxidation | Present, two, four years and final (5 years) | |
Primary | Evaluation of glycation status (1) | Measurement of serum fructosamine and glucose levels | Present, two, four years and final (5 years) | |
Primary | Evaluation of glycation status (2) | Measurement of the percentage of serum glycated hemoglobin | Present, two, four years and final (5 years) | |
Primary | Evaluation of glycation status (3) | Estimation of the percentage of serum glycated albumin | Present, two, four years and final (5 years) | |
Primary | Evaluation of glycation status (4) | Quantification of skin advanced glycation end products (AGEs) | Present, two, four years and final (5 years) | |
Primary | Assessment of Glycoxidation status (1) | Levels of thiobarbituric acid reactive substances (TBARS) also as an estimation of dicarbonyl levels from glycoxidation | Present, two, four years and final (5 years) | |
Primary | Assessment of Glycoxidation status (2) | Quantification of skin advanced glycation end products (AGEs) also as an estimation of the levels of some glycoxidation byproducts | Present, two, four years and final (5 years) | |
Primary | Quantification of arterial targen organ damage (TOD) during the follow-up (1) | Number of patients and severity (Arterial TOD considered as carotid intima-media thickness >0.9 mm, cholesterol plaque, carotid stenosis, carotid-femoral pulse wave velocity >10 m/s, pulse pressure >60 mmHg, ankle-Brachial Index <0.9 or >1.3 hypertensive retinopathy) | Present, two, four years and final (5 years) | |
Primary | Quantification of arterial targen organ damage (TOD) during the follow-up (2) | Number needed to treat (NNT) of consultations and exploration time to detect abnormalities in arterial biomechanics and target organ damage (TOD) | two, four years and final (5 years) | |
Secondary | Evaluation of cardiovascular disease during the follow-up | Number of patients developing cardiovascular and cerebrovascular events, number of hospital admissions and consultations, number of patients with a cardiovascular fatal event, number of patients with disabilities and their degree of disability | two, four years and final (5 years) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03255187 -
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
|
N/A | |
Completed |
NCT04136821 -
The Long-term Effects of Oceanix™ on Resistance Training Adaptations
|
N/A | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Completed |
NCT03358524 -
Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia
|
Phase 4 | |
Recruiting |
NCT05327348 -
Effectiveness of IV Vitamin C in Reducing Oxidative Stress Associated With Free Flap Surgery
|
Phase 3 | |
Completed |
NCT03288623 -
The Effects of Dark Chocolate Implementation in Elite Athletes
|
N/A | |
Completed |
NCT04419025 -
Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease
|
Phase 2 | |
Completed |
NCT04597983 -
Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists
|
N/A | |
Not yet recruiting |
NCT06159543 -
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
|
N/A | |
Enrolling by invitation |
NCT03030456 -
Whole Body Vibrations on Functional Capacity, Muscular Strength, and Biochemical Profile in Elders
|
N/A | |
Completed |
NCT02256254 -
SIMOX - Induction of Oxidative Stress
|
Phase 2 | |
Not yet recruiting |
NCT02202239 -
Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients
|
Phase 4 | |
Recruiting |
NCT02048592 -
Impact of Immunonutrition on the Patients With Cystic Fibrosis
|
Phase 4 | |
Completed |
NCT01942460 -
Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients
|
Phase 4 | |
Completed |
NCT02463318 -
The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects
|
N/A | |
Completed |
NCT02177383 -
Action of Essential Fatty Acids on the Expression of Antioxidant Genes and Athletic Performance
|
N/A | |
Completed |
NCT01990391 -
Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities
|
N/A | |
Completed |
NCT00845130 -
Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes
|
N/A | |
Completed |
NCT00607893 -
Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea
|
N/A | |
Active, not recruiting |
NCT00247507 -
The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients
|
Phase 4 |