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Blood Pressure and Subclinical Organ Damage (Vasorisk)

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ClinicalTrials.gov Identifier: NCT01325064
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : February 21, 2020
Sponsor:
Collaborators:
Castilla-León Health Service
Carlos III Health Institute
Information provided by (Responsible Party):
Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Study Description
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Brief Summary:

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
Diabetes Mellitus

Study Design
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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
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. subclinical organ damage [ Time Frame: december, 1 2013 ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Spain
Luis Garcia Ortiz
Salamanca, Spain, 37003
Sponsors and Collaborators
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Castilla-León Health Service
Carlos III Health Institute
Investigators
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Study Director: Manuel A Gomez Infoslaud Fundation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud:
Carotid Artery Diseases
Blood Pressure
Blood Pressure Monitoring, Ambulatory
Peripheral Vascular Diseases
Retinal Vessels