Lifestyles and Endothelial Dysfunction

NCT ID: NCT01083082

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Healthy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Healthy people
* Ages 20-80 years old

Exclusion Criteria

* Cardiovascular disease
* Respiratory failure
* Patient ends
* Pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

Fundacion para la investigación y formacion en ciencias de la salud

Locations

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Luis Garcia Ortiz

Salamanca, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 26601643 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26437664 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26268844 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25733329 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24742874 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24530775 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23975330 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20459634 (View on PubMed)

Other Identifiers

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PS09/00233

Identifier Type: -

Identifier Source: org_study_id

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