Central blood pressure and pulse wave velocity: relationship to target organ damage and cardiovascular morbidity-mortality in diabetic patients or metabolic syndrome. An observational prospective study. LOD-DIABETES study protocol

BMC Public Health

Study Protocol

Luis García-Ortiz¹  José I Recio-Rodríguez¹  Emiliano Rodríguez-Sánchez¹  Manuel A Gómez-Marcos¹  Carmen Castaño-Sánchez¹  Leticia Gómez-Sánchez¹  Yolanda Castaño-Sánchez¹  Benigna Sánchez-Salgado¹  Carmela Rodríguez-Martín¹  Angela de Cabo-Laso¹ 

[1] La Alamedilla Health Centre, Primary Care Research Unit, Castilla y León Health Service - SACYL, Salamanca, Spain;

关键词: Arterial Stiffness;    Pulse Wave Velocity;    Ambulatory Blood Pressure Monitoring;    Target Organ Damage;    Home Blood Pressure;   

DOI  :  10.1186/1471-2458-10-143

 received in 2010-02-12, accepted in 2010-03-18,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundDiabetic patients show an increased prevalence of non-dipping arterial pressure pattern, target organ damage and elevated arterial stiffness. These alterations are associated with increased cardiovascular risk.The objectives of this study are the following: to evaluate the prognostic value of central arterial pressure and pulse wave velocity in relation to the incidence and outcome of target organ damage and the appearance of cardiovascular episodes (cardiovascular mortality, myocardial infarction, chest pain and stroke) in patients with type 2 diabetes mellitus or metabolic syndrome.Methods/DesignDesign: This is an observational prospective study with 5 years duration, of which the first year corresponds to patient inclusion and initial evaluation, and the remaining four years to follow-up.Setting: The study will be carried out in the urban primary care setting.Study population: Consecutive sampling will be used to include patients diagnosed with type 2 diabetes between 20-80 years of age. A total of 110 patients meeting all the inclusion criteria and none of the exclusion criteria will be included.Measurements: Patient age and sex, family and personal history of cardiovascular disease, and cardiovascular risk factors. Height, weight, heart rate and abdominal circumference. Laboratory tests: hemoglobin, lipid profile, creatinine, microalbuminuria, glomerular filtration rate, blood glucose, glycosylated hemoglobin, blood insulin, fibrinogen and high sensitivity C-reactive protein. Clinical and 24-hour ambulatory (home) blood pressure monitoring and self-measured blood pressure. Common carotid artery ultrasound for the determination of mean carotid intima-media thickness. Electrocardiogram for assessing left ventricular hypertrophy. Ankle-brachial index. Retinal vascular study based on funduscopy with non-mydriatic retinography and evaluation of pulse wave morphology and pulse wave velocity using the SphygmoCor system. The medication used for diabetes, arterial hypertension and hyperlipidemia will be registered, together with antiplatelet drugs.DiscussionThe results of this study will help to know and quantify the prognostic value of central arterial pressure and pulse wave velocity in relation to the evolution of the subclinical target organ damage markers and the possible incidence of cardiovascular events in patients with type 2 diabetes mellitus.Trial RegistrationClinicalTrials.gov Identifier: NCT01065155

【 授权许可】

Unknown   
© Gómez-Marcos et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.