Blood Pressure and Subclinical Organ Damage

Diabetes Mellitus Clinical Trial

— Vasorisk  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325064
• Other study ID #: GRS 498/A/10
• Status: Completed
• Start date: June 2010
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2014
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 34 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
Spain	Luis Garcia Ortiz	Salamanca

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion para la Investigacion y Formacion en Ciencias de la Salud	Carlos III Health Institute, Castilla-León Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subclinical organ damage		december, 1 2013