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Diabetes MellitusVasoriskNCT01325064

Blood Pressure and Subclinical Organ Damage

An observational study of Diabetes Mellitus, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 34 to 75 years
Conditions the study is for
Diabetes Mellitus
How many people
500 participants
Where
1 siteSpain
Study dates
Jun 2010to Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 34 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Patients aged 34 years or more but less than 75 years, with and without type 2 diabetes.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Luis Garcia Ortiz

    Salamanca, 37003

Other trials in Spain

About this study

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

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.

Keywords
Carotid Artery Diseases, Blood Pressure, Blood Pressure Monitoring, Ambulatory, Peripheral Vascular Diseases, Retinal Vessels
Medical subject headings
Diabetes Mellitus, Carotid Artery Diseases, Peripheral Vascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. subclinical organ damage

    Measured: december, 1 2013

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2011 (estimated)
  2. Study startJun 2010
  3. Primary completionDec 2010
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01325064
Sponsor's protocol ID
GRS 498/A/10
Acronym
Vasorisk
Status last verified
Aug 2016
First submitted
27 Mar 2011
Last updated
21 Feb 2020
Results posted
No
Data monitoring committee
No

Publications

  • Gomez-Marcos MA, Recio-Rodriguez JI, Patino-Alonso MC, Agudo-Conde C, Fernandez-Alonso C, Martinez Vizcaino V, Cantera CM, Guenaga-Saenz N, Gonzalez-Viejo N, Garcia-Ortiz L; EVIDENT Study, Spain. Electrocardiographic left ventricular hypertrophy criteria and ambulatory blood pressure monitoring parameters in adults. Am J Hypertens. 2014 Mar;27(3):355-62. doi: 10.1093/ajh/hpt198. Epub 2013 Nov 4.

    PubMed 24190901

  • Gomez-Marcos MA, Recio-Rodriguez JI, Patino-Alonso MC, Agudo-Conde C, Rodriguez-Sanchez E, Gomez-Sanchez L, Gomez-Sanchez M, Garcia-Ortiz L; Vasorisk group. Relationship between uric acid and vascular structure and function in hypertensive patients and sex-related differences. Am J Hypertens. 2013 May;26(5):599-607. doi: 10.1093/ajh/hps097. Epub 2013 Feb 26.

    PubMed 23443729

  • Garcia-Garcia A, Garcia-Ortiz L, Recio-Rodriguez JI, Patino-Alonso MC, Agudo-Conde C, Rodriguez-Sanchez E, Gomez-Marcos MA. Relationship of 24-h blood pressure variability with vascular structure and function in hypertensive patients. Blood Press Monit. 2013 Apr;18(2):101-6. doi: 10.1097/MBP.0b013e32835ebc58.

    PubMed 23388405

  • Garcia-Ortiz L, Recio-Rodriguez JI, Rodriguez-Sanchez E, Patino-Alonso MC, Agudo-Conde C, Rodriguez-Martin C, Castano-Sanchez C, Runkle I, Gomez-Marcos MA. Sodium and potassium intake present a J-shaped relationship with arterial stiffness and carotid intima-media thickness. Atherosclerosis. 2012 Dec;225(2):497-503. doi: 10.1016/j.atherosclerosis.2012.09.038. Epub 2012 Oct 5.

    PubMed 23084712

  • Garcia-Garcia A, Gomez-Marcos MA, Recio-Rodriguez JI, Patino-Alonso MC, Rodriguez-Sanchez E, Agudo-Conde C, Garcia-Ortiz L; Vaso-risk group. Office and 24-hour heart rate and target organ damage in hypertensive patients. BMC Cardiovasc Disord. 2012 Mar 22;12:19. doi: 10.1186/1471-2261-12-19.

    PubMed 22439900

  • Recio-Rodriguez JI, Gomez-Marcos MA, Patino-Alonso MC, Agudo-Conde C, Rodriguez-Sanchez E, Garcia-Ortiz L; Vaso-Risk group. Cocoa intake and arterial stiffness in subjects with cardiovascular risk factors. Nutr J. 2012 Feb 10;11:8. doi: 10.1186/1475-2891-11-8.

    PubMed 22325068

  • Garcia-Ortiz L, Recio-Rodriguez JI, Parra-Sanchez J, Gonzalez Elena LJ, Patino-Alonso MC, Agudo-Conde C, Rodriguez-Sanchez E, Gomez-Marcos MA; Vaso-risk group. A new tool to assess retinal vessel caliber. Reliability and validity of measures and their relationship with cardiovascular risk. J Hypertens. 2012 Apr;30(4):770-7. doi: 10.1097/HJH.0b013e3283506628.

    PubMed 22306849

  • Recio-Rodriguez JI, Gomez-Marcos MA, Patino-Alonso MC, Agudo-Conde C, Rodriguez-Sanchez E, Garcia-Ortiz L; Vasorisk group. Abdominal obesity vs general obesity for identifying arterial stiffness, subclinical atherosclerosis and wave reflection in healthy, diabetics and hypertensive. BMC Cardiovasc Disord. 2012 Feb 1;12:3. doi: 10.1186/1471-2261-12-3.

    PubMed 22292502

  • Garcia-Ortiz L, Ramos-Delgado E, Recio-Rodriguez JI, Agudo-Conde C, Martinez-Salgado C, Patino-Alonso MC, Rodriguez-Sanchez E, Gomez-Marcos MA; Vaso risk group. Peripheral and central arterial pressure and its relationship to vascular target organ damage in carotid artery, retina and arterial stiffness. Development and validation of a tool. The Vaso risk study. BMC Public Health. 2011 Apr 27;11:266. doi: 10.1186/1471-2458-11-266.

    PubMed 21524299

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

subclinical organ damage (time frame: december, 1 2013). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01325064, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.

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