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Blood Pressure and Subclinical Organ Damage (Vasorisk)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2011 by Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor:
Collaborators:
Castilla-León Health Service
Carlos III Health Institute
Information provided by (Responsible Party):
Luis Garcia Ortiz, Fundacion para la Investigacion y Formacion en Ciencias de la Salud
ClinicalTrials.gov Identifier:
NCT01325064
First received: March 27, 2011
Last updated: March 4, 2014
Last verified: April 2011

March 27, 2011
March 4, 2014
June 2010
December 2010   (final data collection date for primary outcome measure)
subclinical organ damage [ Time Frame: december, 1 2013 ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT01325064 on ClinicalTrials.gov Archive Site
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Blood Pressure and Subclinical Organ Damage
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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

The study population will be diabetic type 2 patients with a control group without diabetes mellitus. We will include by consecutive sampling 300 patients between 34 and 75 and without previous cardiovascular disease, half of each group.

Diabetes Mellitus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2014
December 2010   (final data collection date for primary outcome measure)

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.
Both
34 Years to 75 Years
No
Contact: Jose I Recio, Data Manager 923124465 donrecio@gmail.com
Spain
 
NCT01325064
GRS 498/A/10
No
Luis Garcia Ortiz, Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
  • Castilla-León Health Service
  • Carlos III Health Institute
Study Director: Manuel A Gomez Infoslaud Fundation
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP