SchizophreniaNCT01477918
Prevalence of Metabolic Syndrome in Patients With Schizophrenia in Korea
An observational study of Schizophrenia and Metabolic Syndrome, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The aim of this study is to examine the prevalence of the Metabolic syndrome(MetS) in Korean patients with schizophrenia. Primary objective: To investigate the prevalence of the MetS in Korean patients with schizophrenia Secondary objectives: To compare the prevalence of the MetS among 3 groups according to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Metabolic Syndrome
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to not given
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include all patients that met the following criteria: 1. Diagnosis of schizophrenia according to DSM-IV-TR 2. Age between 18-65 years To obtain the representative results for the prevalence of the MetS in schizophrenic patients stratified age and gender, we plan to evaluate about one thousand patients in twenty nationwide centers. 1. 20 centers were selected to provide the representative results of prevalence of the MetS 2. 50 patients in each center were consecutively enrolled
Who may be able to join
- Diagnosis of schizophrenia according to DSM-IV-TR
- Age between 18-65 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan medical center
Seoul, 138-736
Yeon-Ho Joo, Ph. D., 82-2-3010-3412, jooyh@amc.seoul.kr
About this study
The aim of this study is to examine the prevalence of the Metabolic syndrome(MetS) in Korean patients with schizophrenia.
Primary objective:
- To investigate the prevalence of the MetS in Korean patients with schizophrenia
Secondary objectives:
- To compare the prevalence of the MetS among 3 groups according to antipsychotics: typical antipsychotic monotherapy group, atypical antipsychotic monotherapy group, 2 or more antipsychotics group (polypharmacy)
- Conditions
- Schizophrenia, Metabolic Syndrome
- Keywords
- prevalence, Korea
- Medical subject headings
- Schizophrenia, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of metabolic syndrome (MetS)
MetS will be diagnosed according to NCEP ATP III with the Asian-Pacific abdominal obesity criterion (≥90 cm in men, ≥85 cm in women)
3 or more of the following criteria
- fasting plasma glucose >= 100 mg/dl or drug use to treat elevated glucose
- serum triglyceride (TG) >= 150 mg/dl or drug use to treat elevated TG
- HDL cholesterol level < 40mg /dl in males, < 50 mg/dl in female or drug use to treat low HDL
- Systolic BP >=130 mmHg, diastolic BP >=85 or drug use to treat hypertension
- Abdominal obesity : above described
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeon-Ho Joo, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477918
- Sponsor's protocol ID
- MetS_1005
- Status last verified
- Nov 2011
- First submitted
- 20 Nov 2011
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Metabolic Syndrome in Patients With Schizophrenia in Korea
- ClinicalTrials.gov ID
- NCT01477918
- Acronym / sponsor ID
- MetS_1005
- Conditions
- Schizophrenia, Metabolic Syndrome
- Keywords
- prevalence, Korea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- First posted
- 23 Nov 2011 (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 aim of this study is to examine the prevalence of the Metabolic syndrome(MetS) in Korean patients with schizophrenia.
Primary objective:
- To investigate the prevalence of the MetS in Korean patients with schizophrenia
Secondary objectives:
- To compare the prevalence of the MetS among 3 groups according to antipsychotics: typical antipsychotic monotherapy group, atypical antipsychotic monotherapy group, 2 or more antipsychotics group (polypharmacy)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include all patients that met the following criteria: 1. Diagnosis of schizophrenia according to DSM-IV-TR 2. Age between 18-65 years To obtain the representative results for the prevalence of the MetS in schizophrenic patients stratified age and gender, we plan to evaluate about one thousand patients in twenty nationwide centers. 1. 20 centers were selected to provide the representative results of prevalence of the MetS 2. 50 patients in each center were consecutively enrolled
Key inclusion criteria (2 listed)
- Diagnosis of schizophrenia according to DSM-IV-TR
- Age between 18-65 years
Key exclusion criteria (0 listed)
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
prevalence of metabolic syndrome (MetS)
MetS will be diagnosed according to NCEP ATP III with the Asian-Pacific abdominal obesity criterion (≥90 cm in men, ≥85 cm in women) 3 or more of the following criteria 1. fasting plasma glucose >= 100 mg/dl or drug use to treat elevated glucose 2. serum triglyceride (TG) >= 150 mg/dl or drug use to treat elevated TG 3. HDL cholesterol level < 40mg /dl in males, < 50 mg/dl in female or drug use to treat low HDL 4. Systolic BP >=130 mmHg, diastolic BP >=85 or drug use to treat hypertension 5. Abdominal obesity : above described
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
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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.
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 Schizophrenia and Metabolic Syndrome, run by Asan Medical Center at 1 site in South Korea.
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 0 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 Nov 2011. 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 South Korea. 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 Yeon-Ho Joo, Ph.D. (82-2-3010-3412, jooyh@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of metabolic syndrome (MetS). 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 Nov 2011.