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Prevalence of Metabolic Syndrome in Patients With Schizophrenia in Korea

This study is not yet open for participant recruitment.
Verified November 2011 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Yeon-Ho Joo, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01477918
First received: November 20, 2011
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  Purpose

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)


Condition
Schizophrenia
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • prevalence of metabolic syndrome (MetS) [ Designated as safety issue: No ]

    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


Estimated Enrollment: 1000
Study Start Date: December 2011
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia according to DSM-IV-TR
  • Age between 18-65 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477918

Contacts
Contact: Yeon-Ho Joo, Ph.D. 82-2-3010-3412 jooyh@amc.seoul.kr

Locations
Korea, Republic of
Asan medical center Not yet recruiting
Seoul, Korea, Republic of, 138-736
Contact: Yeon-Ho Joo, Ph. D.     82-2-3010-3412     jooyh@amc.seoul.kr    
Sponsors and Collaborators
Asan Medical Center
  More Information

No publications provided

Responsible Party: Yeon-Ho Joo, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01477918     History of Changes
Other Study ID Numbers: MetS_1005
Study First Received: November 20, 2011
Last Updated: November 22, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
prevalence
Korea

Additional relevant MeSH terms:
Schizophrenia
Metabolic Syndrome X
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013