Blood Pressure and Subclinical Organ Damage (Vasorisk)
|ClinicalTrials.gov Identifier: NCT01325064|
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : March 1, 2017
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|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|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2014|
- subclinical organ damage [ Time Frame: december, 1 2013 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325064
|Luis Garcia Ortiz|
|Salamanca, Spain, 37003|
|Study Director:||Manuel A Gomez||Infoslaud Fundation|