Prevalence of Metabolic Syndrome in Patients With Schizophrenia in Korea

November 22, 2011 updated by: Yeon-Ho Joo, Asan Medical Center

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 Overview

Status

Unknown

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • Diagnosis of schizophrenia according to DSM-IV-TR
  • Age between 18-65 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Study Registration Dates

First Submitted

November 20, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (Estimate)

November 23, 2011

Study Record Updates

Last Update Posted (Estimate)

November 23, 2011

Last Update Submitted That Met QC Criteria

November 22, 2011

Last Verified

November 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

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