Lifestyles and Endothelial Dysfunction (EVIDENT)

This study is currently recruiting participants.
Verified March 2011 by Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Luis Garcia Ortiz, Fundacion para la Investigacion y Formacion en Ciencias de la Salud
ClinicalTrials.gov Identifier:
NCT01083082
First received: March 6, 2010
Last updated: March 4, 2014
Last verified: March 2011
  Purpose

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
Healthy

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud:

Primary Outcome Measures:
  • Physical activity [ Time Frame: December, 1 2014 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • diet [ Time Frame: december, 1 2014 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • blood pressure [ Time Frame: december 1, 2014 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1500
Study Start Date: March 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy people 20-80 aged that visit their family doctor and accept be involved in study from six Spanish cities

Criteria

Inclusion Criteria:

  • Healthy people
  • Ages 20-80 years old

Exclusion Criteria:

  • Cardiovascular disease
  • Respiratory failure
  • Patient ends
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083082

Contacts
Contact: Luis Garcia, MD 923124465 Lgarciao@usal.es
Contact: Jose I Recio, N 923124465 donrecio@gmail.com

Locations
Spain
Luis Garcia Ortiz Recruiting
Salamanca, Spain, 37003
Principal Investigator: Luis Garcia Ortiz, MD         
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
  More Information

Additional Information:
No publications provided

Responsible Party: Luis Garcia Ortiz, Dr, Fundacion para la Investigacion y Formacion en Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT01083082     History of Changes
Other Study ID Numbers: PS09/00233
Study First Received: March 6, 2010
Last Updated: March 4, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

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

ClinicalTrials.gov processed this record on April 17, 2014