Role of the Stress in the Development of the Metabolic Syndrome

NCT ID: NCT01538082

Last Updated: 2012-02-23

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

UNKNOWN

Total Enrollment

738 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is determine the incidence of metabolic syndrome (MetS) in people of high risk, of 40 or more years and attended in the Primary Care. Evaluating the association between anxiety, depression, quality of life and the vital stressful events, and the development of the metabolic syndrome in general population.

Our hypothesis is that population of the cohort with bigger degree of stress will develop earlier the metabolic syndrome.

If our hypothesis about the metabolic syndrome are demonstrated, it would allow establishing in a future interventions on these factors of risk to prevent or to decrease the incidence of this syndrome in the Primary Care.

Detailed Description

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Conditions

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Anxiety Disorders Depressive Disorders Metabolic Syndrome Stress Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients without stress

Patients without any of the next items: Zung's questionnaire score over 19 points; SF-12 questionnaire score over 5 points; Stressful vital events score over 150 points.

No interventions assigned to this group

Patients with stress

Patients with stress, including: Zung's questionnaire punctuation over 19 points; SF-12 questionnaire score over 5 points; stressful vital events score over 150 points. All combinations are considered positive in stress.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Both genders, elderly than 40 years
* Subjects with 1 or 2 criteria of NCEP-ATPIII set for Metabolic Syndrome

* Abdominal waist \> 102 cm ( men ) or \>88 cm ( women )
* Blood Pressure ( \>130/85 mmHg ) ( or else pharmacologic treatment of hypertension )
* Hypertriglyceridaemia ( \>150 mg/dl ) ( or else pharmacologic treatment )
* HDL-cholesterol \<40 mg/dl ( men ) or \<50 mg/dl ( women ) ( or else treatment )
* Fasting glucose \> 110 mg/dl.

Exclusion Criteria

* Metabolic Syndrome (NCEP-ATPIII defined)(3 criteria of above mentioned)
* Severe or terminal disease
* Severe mental disease that difficulties the follow-up
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catalan Society of Family Medicine

OTHER

Sponsor Role collaborator

Spanish Society of Family and Community Medicine

OTHER

Sponsor Role collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yolanda Ortega, MD

Role: PRINCIPAL_INVESTIGATOR

Catalan Institute of Health

Juan J Cabré, MD, PhD

Role: STUDY_DIRECTOR

Catalan Institute of Health

Josep L Piñol, MD, PhD

Role: STUDY_CHAIR

Catalan Institute of Health

Locations

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Catalan Health Institute. ABS Reus-4

Reus, Tarragona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Cecilia Borau

Role: CONTACT

934824124

Facility Contacts

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Yolanda Ortega

Role: primary

Other Identifiers

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7Z08/002

Identifier Type: -

Identifier Source: org_study_id

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