Blood Pressure and Subclinical Organ Damage (Vasorisk)

This study is currently recruiting participants.

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:

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

ClinicalTrials.gov Identifier:

NCT01325064

First received: March 27, 2011

Last updated: April 8, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 27, 2011

Last Updated Date

April 8, 2011

Start Date ^ICMJE

June 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01325064 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Blood Pressure and Subclinical Organ Damage

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

December 2014

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

34 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jose I Recio, Data Manager

923124465

donrecio@gmail.com

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01325064

Other Study ID Numbers ^ICMJE

GRS 498/A/10

Has Data Monitoring Committee

Responsible Party

Luis Garcia Ortiz, Fundation Infosalud

Study Sponsor ^ICMJE

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Collaborators ^ICMJE

Castilla-León Health Service
Carlos III Health Institute

Investigators ^ICMJE

Study Director:

Manuel A Gomez

Infoslaud Fundation

Information Provided By

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Verification Date

April 2011

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

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