Blood Pressure and Subclinical Organ Damage (Vasorisk)
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| ClinicalTrials.gov Identifier: NCT01325064 |
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Recruitment Status :
Completed
First Posted : March 29, 2011
Last Update Posted : February 21, 2020
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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 |
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| Diabetes Mellitus |
| Study Type : | Observational |
| Actual Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 ]
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| Ages Eligible for Study: | 34 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion criteria:
- Patients aged 34 years or more but less than 75 years, with and without type 2 diabetes.
Exclusion criteria:
- Patients who fail to meet the requirements of the protocol (mental disorders and / or cognitive uncooperative, education and understanding limitations),
- Patients with ischemic heart disease, cerebrovascular disease or other atherosclerotic disease
- Patients who are participating or will participate in a clinical trial during the study
- Patients with serious comorbidity that might endanger his life in the next 12 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325064
| Spain | |
| Luis Garcia Ortiz | |
| Salamanca, Spain, 37003 | |
| Study Director: | Manuel A Gomez | Infoslaud Fundation |
| Responsible Party: | Fundacion para la Investigacion y Formacion en Ciencias de la Salud |
| ClinicalTrials.gov Identifier: | NCT01325064 |
| Other Study ID Numbers: |
GRS 498/A/10 |
| First Posted: | March 29, 2011 Key Record Dates |
| Last Update Posted: | February 21, 2020 |
| Last Verified: | August 2016 |
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Carotid Artery Diseases Blood Pressure Blood Pressure Monitoring, Ambulatory Peripheral Vascular Diseases Retinal Vessels |