Role of the Stress in the Development of the Metabolic Syndrome

Study Overview
=================
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.

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

Conditions
-----------------
Anxiety Disorders, Depressive Disorders, Metabolic Syndrome, Stress Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients without stress<br>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<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of metabolic syndrome | Determining the incidence of metabolic syndrome ( MetS ) in people of high risk, older than 40 years and attended in the Primary Care. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between risk factors and metabolic syndrome | Association between anxiety, the depression, the quality of life and the vital stressful events and the metabolic syndrome | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety disorders, Depressive disorders, Metabolic syndrome, Stress disorders, Primary care