STREX: Role of the Stress in the Development of the Metabolic Syndrome

Sponsor

Jordi Gol i Gurina Foundation (Other)

Overall Status

Unknown status

CT.gov ID

NCT01538082

Collaborator

Catalan Society of Family Medicine (Other), Spanish Society of Family and Community Medicine (Other)

738

Enrollment

Location

Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders Depressive Disorders Metabolic Syndrome Stress Disorders

Study Design

Study Type:

Observational

Anticipated Enrollment :

738 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Role of Anxiety, Depression, Quality of Life and Stressful Vital Events in the Development of the Metabolic Syndrome. StreX Project.

Study Start Date :

Dec 1, 2008

Anticipated Primary Completion Date :

Mar 1, 2013

Anticipated Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

Incidence of metabolic syndrome [One year]
Determining the incidence of metabolic syndrome ( MetS ) in people of high risk, older than 40 years and attended in the Primary Care.

Secondary Outcome Measures

Association between risk factors and metabolic syndrome [One year]
Association between anxiety, the depression, the quality of life and the vital stressful events and the metabolic syndrome

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.