Role of the Stress in the Development of the Metabolic Syndrome (STREX)

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

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.

Study Overview

• Status: Unknown
• Conditions: Anxiety Disorders; Metabolic Syndrome; Stress Disorders; Depressive Disorders

• Study Type: Observational
• Enrollment (Anticipated): 738

Contacts and Locations

• Study Contact: Name: Cecilia Borau; Phone Number: 934824124; Email: cborau@idiapjgol.org

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, 43202
      • Recruiting
      • Catalan Health Institute. ABS Reus-4
      • Contact: Yolanda Ortega; Email: yortega.tarte.ics@gencat.cat
      • Principal Investigator: Yolanda Ortega, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Aleatory sample of subjects with high risk ( 1 or 2 criteria NCEP-ATPIII ) to develop Metabolic Syndrome, elderly than 40 years and attended in Primary Care in the last year. This sample will be provided by the Information's Technology in Primary Care Services.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

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

Collaborators and Investigators

• Sponsor: Jordi Gol i Gurina Foundation
• Collaborators: Catalan Society of Family Medicine; Spanish Society of Family and Community Medicine
• Investigators: Principal Investigator: Yolanda Ortega, MD, Catalan Institute of Health; Study Director: Juan J Cabré, MD, PhD, Catalan Institute of Health; Study Chair: Josep L Piñol, MD, PhD, Catalan Institute of Health

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: February 19, 2012
• First Submitted That Met QC Criteria: February 19, 2012
• First Posted (Estimate): February 23, 2012

Study Record Updates

• Last Update Posted (Estimate): February 23, 2012
• Last Update Submitted That Met QC Criteria: February 19, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Primary care; Anxiety disorders; Depressive disorders; Stress disorders
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Mood Disorders; Trauma and Stressor Related Disorders; Insulin Resistance; Hyperinsulinism; Depression; Depressive Disorder; Syndrome; Disease; Anxiety Disorders; Stress Disorders, Traumatic; Metabolic Syndrome
• Other Study ID Numbers: 7Z08/002