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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01477918
Other study ID # MetS_1005
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 20, 2011
Last updated November 22, 2011
Start date December 2011

Study information

Verified date November 2011
Source Asan Medical Center
Contact Yeon-Ho Joo, Ph.D.
Phone 82-2-3010-3412
Email jooyh@amc.seoul.kr
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical 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 antipsychotics: typical antipsychotic monotherapy group, atypical antipsychotic monotherapy group, 2 or more antipsychotics group (polypharmacy)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Diagnosis of schizophrenia according to DSM-IV-TR

- Age between 18-65 years

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Asan medical center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
No
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