Role of the Stress in the Development of the Metabolic Syndrome

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

• Registration Number: NCT01538082
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Status Verified: 2012-02
• Study First Submitted: 2012-02-19
• Study First Submitted QC: 2012-02-19
• Last Update Submitted: 2012-02-19
• Study First Posted: 2012-02-23
• Last Update Posted: 2012-02-23
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 738

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Catalan Health Institute. ABS Reus-4; 🇪🇸 Reus, Tarragona, Spain