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EVIDENT: Lifestyles and Endothelial Dysfunction

Sponsor
Fundacion para la Investigacion y Formacion en Ciencias de la Salud (Other)
Overall Status
Completed
CT.gov ID
NCT01083082
Collaborator
Instituto de Salud Carlos III (Other)
1,500
Enrollment
1
Location
76
Duration (Months)
19.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objectives: To analyze the relationship of physical activity, fitness, energy intake and dietary pattern with the circadian pattern of blood pressure, central and peripheral blood pressure pulse wave velocity and biological markers of endothelial dysfunction in active and sedentary people without atherosclerotic disease.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Objectives: To analyze the relationship of physical activity, fitness, energy intake and dietary pattern with the circadian pattern od blood pressure, central and peripheral blood pressure pulse wave velocity and biological markers of endothelial dysfunction in active and sedentary people without atherosclerotic disease.

    Methods:

    Design: Cross- sectional study 1ª step of clinical trial later. Project multicentric with seis research groups.

    Subjects: From subjects of PEPAF project cohort, that remain in last control 3105 (1.163 active and sedentary 1942) and 2346 were excluded for actives. By Random sampling included 352 subjects who remained sedentary, 588 who have become active and 560 of which were excluded for being active in baseline assessment, a total of 1,200. Each of the six groups included 250 subjects.

    Measurements: We evaluated height, weight, abdominal perimeter, blood pressure clinic, ambulatory blood pressure with Radial pulse wave acquisition device (BPro), central blood pressure, (aortic) and Augmentation index with Pulse Wave Application Software (A-Pulse) and Sphigmo cor System Px (Pulse Wave Analysis), pulse wave velocity (PWV) with Sphigmo cor System Px (Pulse Wave velocity), nutritional pattern with a food consumption survey, physical activity 7 Par-day questionnaire and the accelerometer (MTI/CSA 7164) and physical fitness with cicloergometro (PWC170) and endothelial dysfunction biomarkers (endoglin and osteoprotegerin).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1500 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Physical Exercise, Fitness and Dietary Pattern and Theirs Relationship With Blood Pressure Circadian Pattern, Augmentation Index and Endothelial Dysfunction Biological Markers. (EVIDENT Study)
    Study Start Date :
    Mar 1, 2010
    Actual Primary Completion Date :
    Jun 1, 2016
    Actual Study Completion Date :
    Jul 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Physical activity [December, 1 2014]

    Secondary Outcome Measures

    1. diet [december, 1 2014]

    Other Outcome Measures

    1. blood pressure [december 1, 2014]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy people

    • Ages 20-80 years old

    Exclusion Criteria:

    • Cardiovascular disease

    • Respiratory failure

    • Patient ends

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Luis Garcia Ortiz Salamanca Spain 37003

    Sponsors and Collaborators

    • Fundacion para la Investigacion y Formacion en Ciencias de la Salud
    • Instituto de Salud Carlos III

    Investigators

    • Principal Investigator: Luis Garcia, MD, Fundacion para la investigación y formacion en ciencias de la salud

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Fundacion para la Investigacion y Formacion en Ciencias de la Salud
    ClinicalTrials.gov Identifier:
    NCT01083082
    Other Study ID Numbers:
    • PS09/00233
    First Posted:
    Mar 9, 2010
    Last Update Posted:
    Feb 24, 2020
    Last Verified:
    Feb 1, 2020
    Keywords provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud
    lifestyles
    diet
    exercise
    central blood pressure
    arterial stiffness
    endothelial dysfunction
    Healthy people

    Study Results

    No Results Posted as of Feb 24, 2020