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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Jordi Gol i Gurina Foundation.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Catalan Society of Family Medicine
semFYC
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01538082
First received: February 19, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

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.


Condition
Anxiety Disorders
Depressive Disorders
Metabolic Syndrome
Stress Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Anxiety, Depression, Quality of Life and Stressful Vital Events in the Development of the Metabolic Syndrome. StreX Project.

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Incidence of metabolic syndrome [ Time Frame: One year ] [ Designated as safety issue: No ]
    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:
  • Association between risk factors and metabolic syndrome [ Time Frame: One year ] [ Designated as safety issue: No ]
    Association between anxiety, the depression, the quality of life and the vital stressful events and the metabolic syndrome


Estimated Enrollment: 738
Study Start Date: December 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538082

Contacts
Contact: Cecilia Borau 934824124 cborau@idiapjgol.org

Locations
Spain
Catalan Health Institute. ABS Reus-4 Recruiting
Reus, Tarragona, Spain, 43202
Contact: Yolanda Ortega       yortega.tarte.ics@gencat.cat   
Principal Investigator: Yolanda Ortega, MD         
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Catalan Society of Family Medicine
semFYC
Investigators
Principal Investigator: Yolanda Ortega, MD Catalan Health Institute
Study Director: Juan J Cabré, MD, PhD Catalan Health Institute
Study Chair: Josep L Piñol, MD, PhD Catalan Health Institute
  More Information

No publications provided

Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01538082     History of Changes
Other Study ID Numbers: 7Z08/002
Study First Received: February 19, 2012
Last Updated: February 19, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Jordi Gol i Gurina Foundation:
Anxiety disorders
Depressive disorders
Metabolic syndrome
Stress disorders
Primary care

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Disease
Metabolic Syndrome X
Stress Disorders, Traumatic
Syndrome
Behavioral Symptoms
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Mental Disorders
Metabolic Diseases
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014