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NCT01083082 Clinical Trial

Lifestyles and Endothelial Dysfunction

Healthy Clinical Trial

— EVIDENT  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01083082
Other study ID # PS09/00233
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2010
Est. completion date July 2016

Study information
Verified date February 2020
Source Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 1ยช 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).

Recruitment information / eligibility
Status Completed
Enrollment 1500
Est. completion date July 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Healthy people

- Ages 20-80 years old

Exclusion Criteria:

- Cardiovascular disease

- Respiratory failure

- Patient ends

- Pregnancy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Luis Garcia Ortiz Salamanca

Sponsors (2)
Lead Sponsor Collaborator
Fundacion para la Investigacion y Formacion en Ciencias de la Salud Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Other blood pressure december 1, 2014
Primary Physical activity December, 1 2014
Secondary diet december, 1 2014
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