ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01538082
Recruitment Status : Unknown
Verified February 2012 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Recruiting
First Posted : February 23, 2012
Last Update Posted : February 23, 2012
Sponsor:
Collaborators:
Catalan Society of Family Medicine
Spanish Society of Family and Community Medicine
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

February 19, 2012
February 23, 2012
February 23, 2012
December 2008
March 2013   (Final data collection date for primary outcome measure)
Incidence of metabolic syndrome [ Time Frame: One year ]
Determining the incidence of metabolic syndrome ( MetS ) in people of high risk, older than 40 years and attended in the Primary Care.
Same as current
No Changes Posted
Association between risk factors and metabolic syndrome [ Time Frame: One year ]
Association between anxiety, the depression, the quality of life and the vital stressful events and the metabolic syndrome
Same as current
Not Provided
Not Provided
 
Role of the Stress in the Development of the Metabolic Syndrome
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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.
  • Anxiety Disorders
  • Depressive Disorders
  • Metabolic Syndrome
  • Stress Disorders
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
738
Same as current
March 2013
March 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01538082
7Z08/002
No
Not Provided
Not Provided
Jordi Gol i Gurina Foundation
Jordi Gol i Gurina Foundation
  • Catalan Society of Family Medicine
  • Spanish Society of Family and Community Medicine
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
Jordi Gol i Gurina Foundation
February 2012