Lifestyles and Endothelial Dysfunction (EVIDENT)
|ClinicalTrials.gov Identifier: NCT01083082|
Recruitment Status : Completed
First Posted : March 9, 2010
Last Update Posted : August 31, 2016
|Condition or disease|
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.
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 Type :||Observational|
|Actual Enrollment :||1500 participants|
|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 :||March 2010|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||July 2016|
- Physical activity [ Time Frame: December, 1 2014 ]
- diet [ Time Frame: december, 1 2014 ]
- blood pressure [ Time Frame: december 1, 2014 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083082
|Luis Garcia Ortiz|
|Salamanca, Spain, 37003|
|Principal Investigator:||Luis Garcia, MD||Fundacion para la investigación y formacion en ciencias de la salud|