Anxiety DisordersSTREXNCT01538082
Role of the Stress in the Development of the Metabolic Syndrome
An observational study of Anxiety Disorders and Depressive Disorders, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Anxiety Disorders, Depressive Disorders, Metabolic Syndrome
- How many people
- 738 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2008to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Metabolic Syndrome (NCEP-ATPIII defined)(3 criteria of above mentioned)
- Severe or terminal disease
- Severe mental disease that difficulties the follow-up
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Catalan Health Institute. ABS Reus-4
Reus, Tarragona, 43202
Yolanda Ortega, yortega.tarte.ics@gencat.cat
Yolanda Ortega, MD
About this study
Official title: 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.
- Keywords
- Anxiety disorders, Depressive disorders, Metabolic syndrome, Stress disorders, Primary care
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Metabolic Syndrome, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startDec 2008
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 738 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC), Spanish Society of Family and Community Medicine
- Responsible party
- Sponsor
- Investigators
- Yolanda Ortega, MD, Principal investigator, Catalan Institute of HealthJuan J Cabré, MD, PhD, Study director, Catalan Institute of HealthJosep L Piñol, MD, PhD, Study chair, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538082
- Sponsor's protocol ID
- 7Z08/002
- Acronym
- STREX
- Status last verified
- Feb 2012
- First submitted
- 19 Feb 2012
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Anxiety, Depression, Quality of Life and Stressful Vital Events in the Development of the Metabolic Syndrome. StreX Project.
- ClinicalTrials.gov ID
- NCT01538082
- Acronym / sponsor ID
- STREX / 7Z08/002
- Keywords
- Anxiety disorders, Depressive disorders, Metabolic syndrome, Stress disorders, Primary care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 738 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC), Spanish Society of Family and Community Medicine
- Study start
- Dec 2008
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Both genders, elderly than 40 years
- Subjects with 1 or 2 criteria of NCEP-ATPIII set for Metabolic Syndrome
Key exclusion criteria (3 listed)
- Metabolic Syndrome (NCEP-ATPIII defined)(3 criteria of above mentioned)
- Severe or terminal disease
- Severe mental disease that difficulties the follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Association between risk factors and metabolic syndrome
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders and Depressive Disorders, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecilia Borau (934824124, cborau@idiapjgol.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of metabolic syndrome (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2012.