Diabetes Mellitus Clinical Trial
Official title:
Central and Peripheral Blood Pressure and Its Relation With Vascular Target Organ Damage in Carotid, Retinal and Arterial Stiffness. Developed and Validation of a Tool
Background: The purpose of this study is to analyze the relationship between central and
peripheral blood pressure (clinic and ambulatory) with vascular structure and function,
assessed by carotid intima-media thickness (IMT), artery venous retinal index, pulse wave
velocity (PWV) and ankle-brachial index in patients with diabetes type 2 and without diabetes
type 2. Develop and validate a software to measure the retinal vessels and to estimate
arterio-venous index automatically.
Methods/design: The investigators will Perform a coss-sectional study with control group,
with follow-up of 4 years in primary care. The study population will be diabetic type 2
patients with a control group without diabetes mellitus. The investigators will include by
consecutive sampling 300 patients between 34 and 75 and without previous cardiovascular
disease, half of each group. Main measurements: age, sex, height, weight and waist
circumference. Lipids, creatinine, microalbuminuria, blood glucose, HbA1C, insulin,
fibrinogen, hs-CRP and markers of endothelial dysfunction. Clinic and ambulatory blood
pressure (MAPA). Ultrasonography to assess carotid IMT, retinography to assess arterio-venous
ratio. ECG to evaluate left ventricular hypertrophy, ankle-brachial index and morphology
analysis (PWA) and pulse wave velocity (PWV) in Sphigmocor System.
Discussion: The investigators provide information regarding various parameters derived from
MAPA and pulse wave analysis of with target organ damage, especially with the vascular
structure and function assessed by IMT and PWV and endothelial dysfunction in patients with
diabetes type 2 and without this disease. The investigators also hope to demonstrate the
usefulness of the tool developed for automatic evaluation of retinal vascularization in the
early detection of abnormalities of vascular structure and function and the prognosis of
cardiovascular disease in the medium term.
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