Lifestyles and Endothelial Dysfunction (EVIDENT)
Recruitment status was Recruiting
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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) |
| Estimated Enrollment: | 1500 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
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 |
Healthy people 20-80 aged that visit their family doctor and accept be involved in study from six Spanish cities
Inclusion Criteria:
- Healthy people
- Ages 20-80 years old
Exclusion Criteria:
- Cardiovascular disease
- Respiratory failure
- Patient ends
- Pregnancy
Contacts and Locations| Contact: Luis Garcia, MD | 923124465 | Lgarciao@usal.es |
| Contact: Jose I Recio, N | 923124465 | donrecio@gmail.com |
| Spain | |
| Luis Garcia Ortiz | Recruiting |
| Salamanca, Spain, 37003 | |
| Principal Investigator: Luis Garcia Ortiz, MD | |
| 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, Fundación Infosalud |
| ClinicalTrials.gov Identifier: | NCT01083082 History of Changes |
| Other Study ID Numbers: | PS09/00233 |
| Study First Received: | March 6, 2010 |
| Last Updated: | March 27, 2011 |
| 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 May 23, 2013