- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01083082
Lifestyles and Endothelial Dysfunction (EVIDENT)
Physical Exercise, Fitness and Dietary Pattern and Theirs Relationship With Blood Pressure Circadian Pattern, Augmentation Index and Endothelial Dysfunction Biological Markers. (EVIDENT Study)
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Salamanca, Spain, 37003
- Luis Garcia Ortiz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy people
- Ages 20-80 years old
Exclusion Criteria:
- Cardiovascular disease
- Respiratory failure
- Patient ends
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Physical activity
Time Frame: December, 1 2014
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December, 1 2014
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
diet
Time Frame: december, 1 2014
|
december, 1 2014
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood pressure
Time Frame: december 1, 2014
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december 1, 2014
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Luis Garcia, MD, Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Publications and helpful links
General Publications
- Garcia-Hermoso A, Martinez-Vizcaino V, Recio-Rodriguez JI, Diez-Fernandez A, Gomez-Marcos MA, Garcia-Ortiz L; Evident Group. Abdominal obesity as a mediator of the influence of physical activity on insulin resistance in Spanish adults. Prev Med. 2016 Jan;82:59-64. doi: 10.1016/j.ypmed.2015.11.012. Epub 2015 Nov 19.
- Garcia-Hermoso A, Martinez-Vizcaino V, Sanchez-Lopez M, Recio-Rodriguez JI, Gomez-Marcos MA, Garcia-Ortiz L; EVIDENT Group. Moderate-to-vigorous physical activity as a mediator between sedentary behavior and cardiometabolic risk in Spanish healthy adults: a mediation analysis. Int J Behav Nutr Phys Act. 2015 Jun 20;12:78. doi: 10.1186/s12966-015-0244-y.
- Patino-Alonso MC, Recio-Rodriguez JI, Magdalena-Belio JF, Gine-Garriga M, Martinez-Vizcaino V, Fernandez-Alonso C, Arietaleanizbeaskoa MS, Galindo-Villardon MP, Gomez-Marcos MA, Garcia-Ortiz L; EVIDENT Group. Clustering of lifestyle characteristics and their association with cardio-metabolic health: the Lifestyles and Endothelial Dysfunction (EVIDENT) study. Br J Nutr. 2015 Sep 28;114(6):943-51. doi: 10.1017/S0007114515002500. Epub 2015 Aug 13.
- Garcia-Hermoso A, Martinez-Vizcaino V, Recio-Rodriguez JI, Sanchez-Lopez M, Gomez-Marcos MA, Garcia-Ortiz L; EVIDENT Group. Sedentary behaviour patterns and carotid intima-media thickness in Spanish healthy adult population. Atherosclerosis. 2015 Apr;239(2):571-6. doi: 10.1016/j.atherosclerosis.2015.02.028. Epub 2015 Feb 23.
- Gomez-Marcos MA, Recio-Rodriguez JI, Patino-Alonso MC, Agudo-Conde C, Lasaosa-Medina L, Rodriguez-Sanchez E, Maderuelo-Fernandez JA, Garcia-Ortiz L; EVIDENT Group. Relationship between objectively measured physical activity and vascular structure and function in adults. Atherosclerosis. 2014 Jun;234(2):366-72. doi: 10.1016/j.atherosclerosis.2014.02.028. Epub 2014 Mar 18.
- Garcia-Ortiz L, Recio-Rodriguez JI, Schmidt-Trucksass A, Puigdomenech-Puig E, Martinez-Vizcaino V, Fernandez-Alonso C, Rubio-Galan J, Agudo-Conde C, Patino-Alonso MC, Rodriguez-Sanchez E, Gomez-Marcos MA; EVIDENT Group. Relationship between objectively measured physical activity and cardiovascular aging in the general population--the EVIDENT trial. Atherosclerosis. 2014 Apr;233(2):434-440. doi: 10.1016/j.atherosclerosis.2014.01.021. Epub 2014 Jan 24.
- Garcia-Ortiz L, Recio-Rodriguez JI, Puig-Ribera A, Lema-Bartolome J, Ibanez-Jalon E, Gonzalez-Viejo N, Guenaga-Saenz N, Agudo-Conde C, Patino-Alonso MC, Gomez-Marcos MA; EVIDENT Group. Blood pressure circadian pattern and physical exercise assessment by accelerometer and 7-day physical activity recall scale. Am J Hypertens. 2014 May;27(5):665-73. doi: 10.1093/ajh/hpt159. Epub 2013 Aug 24.
- Garcia-Ortiz L, Recio-Rodriguez JI, Martin-Cantera C, Cabrejas-Sanchez A, Gomez-Arranz A, Gonzalez-Viejo N, Iturregui-San Nicolas E, Patino-Alonso MC, Gomez-Marcos MA; EVIDENT Group. Physical exercise, fitness and dietary pattern and their relationship with circadian blood pressure pattern, augmentation index and endothelial dysfunction biological markers: EVIDENT study protocol. BMC Public Health. 2010 May 6;10:233. doi: 10.1186/1471-2458-10-233.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PS09/00233
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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