CClinicalTrials.gg
Status unknownNCT01538082STREXUpdated Feb 23, 2012

Role of the Stress in the Development of the Metabolic Syndrome

An observational study in Anxiety Disorders, Depressive Disorders and Metabolic Syndrome, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Status unknown at 1 site in Spain. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2012-02-23.

Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Observational

The sponsor has not verified this record recently (last verified Feb 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
738
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anxiety Disorders
  • Depressive Disorders
  • Metabolic Syndrome
  • Stress Disorders

Keywords

  • Anxiety disorders
  • Depressive disorders
  • Metabolic syndrome
  • Stress disorders
  • Primary care
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's planned enrollment of 738 is above the median of 200 across 458 observational studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Metabolic Syndrome (NCEP-ATPIII defined)(3 criteria of above mentioned)
  • Severe or terminal disease
  • Severe mental disease that difficulties the follow-up
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
738 participants (estimated)

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: One year

Secondary outcomes

  1. 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

    Time frame: One year

07

Study locations

1 of 1 sites recruiting
  • Catalan Health Institute. ABS Reus-4
    Reus, Tarragona 43202, Spain
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01538082
Lead sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Catalan Society of Family Medicine, Spanish Society of Family and Community Medicine
Responsible party
Sponsor
First posted
Feb 23, 2012
Start date
Dec 2008
Primary completion
Mar 2013 (estimated)
Completion
Mar 2013 (estimated)
Last update
Feb 23, 2012

Study contacts

Cecilia Borau
Contact
cborau@idiapjgol.org
934824124
Yolanda Ortega, MD
principal investigator · Catalan Institute of Health
Juan J Cabré, MD, PhD
study director · Catalan Institute of Health
Josep L Piñol, MD, PhD
study chair · Catalan Institute of Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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