Role of the Stress in the Development of the Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— STREX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01538082
• Other study ID #: 7Z08/002
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2012
• Last updated: February 19, 2012
• Start date: December 2008
• Est. completion date: March 2013

Study information

• Verified date: February 2012
• Source: Jordi Gol i Gurina Foundation
• Contact: Cecilia Borau
• Phone: 934824124
• Email: cborau[@]idiapjgol.org
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 738
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorders
• Disease
• Metabolic Syndrome
• Metabolic Syndrome X
• Stress Disorders
• Stress Disorders, Traumatic
• Syndrome

Locations

Country	Name	City	State
Spain	Catalan Health Institute. ABS Reus-4	Reus	Tarragona

Sponsors (3)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Catalan Society of Family Medicine, Spanish Society of Family and Community Medicine

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No