Blood Pressure and Subclinical Organ Damage (Vasorisk)

February 20, 2020 updated by: Fundacion para la Investigacion y Formacion en Ciencias de la Salud

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Salamanca, Spain, 37003
        • Luis Garcia Ortiz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

34 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
subclinical organ damage
Time Frame: december, 1 2013
december, 1 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Collaborators

Carlos III Health Institute
Castilla-León Health Service

Investigators

  • Study Director: Manuel A Gomez, Infoslaud Fundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 27, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (Estimate)

March 29, 2011

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GRS 498/A/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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