Role of the Stress in the Development of the Metabolic Syndrome

NCT01538082 | Unknown

• 1 other identifier: 7Z08/002
• Study Type: observational
• Target: 738
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depressive Disorders; Metabolic Syndrome; Stress Disorders

Keywords

Anxiety disorders; Depressive disorders; Metabolic syndrome; Stress disorders; Primary care

Outcome Measures

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.

  One year

Secondary Outcomes (1)

• Association between risk factors and metabolic syndrome

  One year

Study Arms (2)

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 Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC): collaborator
• Spanish Society of Family and Community Medicine: collaborator

Study Sites (1)

Catalan Health Institute. ABS Reus-4

Reus, Tarragona, 43202, Spain

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Metabolic Syndrome; Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Trauma and Stressor Related Disorders

Study Officials

• Yolanda Ortega, MD

  Catalan Institute of Health

  PRINCIPAL INVESTIGATOR

• Juan J Cabré, MD, PhD

  Catalan Institute of Health

  STUDY DIRECTOR

• Josep L Piñol, MD, PhD

  Catalan Institute of Health

  STUDY CHAIR

Central Study Contacts

Cecilia Borau

CONTACT

934824124; cborau@idiapjgol.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2012
• First Posted: February 23, 2012
• Study Start: December 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 23, 2012

Record last verified: 2012-02

Locations

ES (1)