Metabolic SyndromeNCT01587521
Prevalence of and Factors Associated With Metabolic Syndrome in Schizophrenia
An observational study of Metabolic Syndrome and Quality of Life, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Patients with schizophrenia are more likely to have metabolic syndrome compared to general population. The criterion for metabolic syndrome in Asian people including: elevated waist circumference (male ≥ 90cm, female ≥ 80cm), elevated triglycerides ≥ 150mg/dL, reduced HDL cholesterol: male < 40mg/dL, female < 50mg/dL… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Metabolic Syndrome, Quality of Life, Depression
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2012to Jun 2016
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with schizophrenia
Who may be able to join
- Diagnosis of schizophrenia according to DSM-IV-TR
- Aged 18 years-old or over
Who cannot join
- Having organic brain syndromes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of and Factors Associated With Metabolic Syndrome in Patients With Schizophrenia
Patients with schizophrenia are more likely to have metabolic syndrome compared to general population. The criterion for metabolic syndrome in Asian people including: elevated waist circumference (male ≥ 90cm, female ≥ 80cm), elevated triglycerides ≥ 150mg/dL, reduced HDL cholesterol: male < 40mg/dL, female < 50mg/dL, elevated blood pressure: ≥ 130/85 mmHg, elevated fasting glucose: ≥ 100mg/dL. Several factors have been found to be associated with metabolic syndrome in schizophrenia, e.g. age, antipsychotic drugs, smoking, family history of metabolic disorder, stress, and quality of life.
However, little is known about the prevalence of and factors associated in Asian. This study aimed to:
- Identify the prevalence of metabolic syndrome in patients with schizophrenia.
- Identify the factors associated with metabolic syndrome in patients with schizophrenia.
Read the detailed description
Patients with schizophrenia are more likely to have metabolic syndrome compared to general population. The criterion for metabolic syndrome in Asian people including: elevated waist circumference (male ≥ 90cm, female ≥ 80cm), elevated triglycerides ≥ 150mg/dL, reduced HDL cholesterol: male < 40mg/dL, female < 50mg/dL, elevated blood pressure: ≥ 130/85 mmHg, elevated fasting glucose: ≥ 100mg/dL. Several factors have been found to be associated with metabolic syndrome in schizophrenia, e.g. age, antipsychotic drugs, smoking, family history of metabolic disorder, stress, and quality of life.
However, little is known about the prevalence of and factors associated in Asian. This study aimed to:
- Identify the prevalence of metabolic syndrome in patients with schizophrenia.
- Identify the factors associated with metabolic syndrome in patients with schizophrenia.
Method This study is a cross-sectional study conducting at the Faculty of Medicine, Chiang Mai University. Eighty participants will be recruited with the inclusion criteria of having diagnosed with schizophrenia according to DSM-IV-TR and aged 18 years or over. The exclusion criterion is having organic brain syndrome.
Measurements PANSS CDSS WHOQOL-BREF-THAI
- Conditions
- Metabolic Syndrome, Quality of Life, Depression
- Keywords
- Metabolic syndrome, Prevalence, Quality of life, Depression, Antipsychotics
- Medical subject headings
- Metabolic Syndrome, Depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirijit Suttajit, Chiang Mai University
- Investigators
- Sirijit Suttajit, MD. MSc., Study director, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587521
- Sponsor's protocol ID
- PSY-11-07-26A-12
- Status last verified
- Jul 2016
- First submitted
- 26 Apr 2012
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of and Factors Associated With Metabolic Syndrome in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01587521
- Acronym / sponsor ID
- PSY-11-07-26A-12
- Conditions
- Metabolic Syndrome, Quality of Life, Depression
- Keywords
- Metabolic syndrome, Prevalence, Quality of life, Depression, Antipsychotics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Apr 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.
Patients with schizophrenia are more likely to have metabolic syndrome compared to general population. The criterion for metabolic syndrome in Asian people including: elevated waist circumference (male ≥ 90cm, female ≥ 80cm), elevated triglycerides ≥ 150mg/dL, reduced HDL cholesterol: male < 40mg/dL, female < 50mg/dL, elevated blood pressure: ≥ 130/85 mmHg, elevated fasting glucose: ≥ 100mg/dL. Several factors have been found to be associated with metabolic syndrome in schizophrenia, e.g. age, antipsychotic drugs, smoking, family history of metabolic disorder, stress, and quality of life.
However, little is known about the prevalence of and factors associated in Asian. This study aimed to:
- Identify the prevalence of metabolic syndrome in patients with schizophrenia.
- Identify the factors associated with metabolic syndrome in patients with schizophrenia.
Detailed description
Patients with schizophrenia are more likely to have metabolic syndrome compared to general population. The criterion for metabolic syndrome in Asian people including: elevated waist circumference (male ≥ 90cm, female ≥ 80cm), elevated triglycerides ≥ 150mg/dL, reduced HDL cholesterol: male < 40mg/dL, female < 50mg/dL, elevated blood pressure: ≥ 130/85 mmHg, elevated fasting glucose: ≥ 100mg/dL. Several factors have been found to be associated with metabolic syndrome in schizophrenia, e.g. age, antipsychotic drugs, smoking, family history of metabolic disorder, stress, and quality of life.
However, little is known about the prevalence of and factors associated in Asian. This study aimed to:
- Identify the prevalence of metabolic syndrome in patients with schizophrenia.
- Identify the factors associated with metabolic syndrome in patients with schizophrenia.
Method This study is a cross-sectional study conducting at the Faculty of Medicine, Chiang Mai University. Eighty participants will be recruited with the inclusion criteria of having diagnosed with schizophrenia according to DSM-IV-TR and aged 18 years or over. The exclusion criterion is having organic brain syndrome.
Measurements PANSS CDSS WHOQOL-BREF-THAI
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with schizophrenia
Key inclusion criteria (2 listed)
- Diagnosis of schizophrenia according to DSM-IV-TR
- Aged 18 years-old or over
Key exclusion criteria (1 listed)
- Having organic brain syndromes
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
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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.
Sirijit Suttajit, MD. MSc. study director
Chiang Mai University
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 Metabolic Syndrome and Quality of Life, run by Chiang Mai University at 1 site in Thailand.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 28 Jul 2016. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 28 Jul 2016.