Prevalence of the Metabolic Syndrome in SPR Taking Antips... | NCT00569504

Studies
Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics

NCT00569504

Sponsor

Seoul National Hospital

Status

Unknown status

Last Update Posted

Jun 12, 2009Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Metabolic Syndrome
Schizophrenia

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PMSPSTA

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Not provided

Completion Date

Sep 2009Estimated

First Submitted Date

Dec 6, 2007

First Submission Date that Met QC Criteria

Dec 6, 2007

First Posted Date

Dec 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2009

Last Update Posted Date

Jun 12, 2009Estimated

Name	Class
Korea Otsuka Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the cross-sectional prevalence of the metabolic syndrome in patients with schizophrenia taking antipsychotics.

Detailed Description

Schizophrenic patients taking any kind of antipsychotics for at least 1 year at the Seoul National Hospital will be participated in this study.

we are planning to enroll approximately 1000 patients with schizophrenia.

For each subject

abdominal circumference
body mass index
lipid profile : TG, HDL-chlo, total chol
systolic/diastolic blood pressure
fasting blood glucose will be measured.

we will calculate the rates of patients who meet the criteria for the Metabolic syndrome.

Abdominal obesity : absolute criteria
2 or more of followings
1. Triglyceride ≥ 150mg/dL or ongoing treatment
2. HDL-cholesterol < 40mg/dL (men) HDL-cholesterol < 50mg/dL (female) or ongoing treatment
3. Hypertension 130mmHg ≥ systolic 85mmHg ≥ diastolic or ongoing treatment
4. FBS ≥ 100mg/dL or previous diagnosis of type II DM

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Label	Type	Description	Intervention Names
A, observatoin		inpatients and outpatients in Seoul National Hospital

Measure	Description	Time Frame
metabolic syndrome		cross-sectional

Measure	Description	Time Frame
each factor of metabolic syndrome

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients taking a same antipsychotics at least more than one year
schizophrenia or schizoaffective disorder

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

DSM-IV diagnosis of schizophrenia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shi Hyun Kang, M.D.	Contact	82-2-2204-0326		drshe@hanmail.net

Overall Officials

Name	Affiliation	Role
Jong-il Lee, M.D.	Seoul National Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National Hospital	Recruiting	Seoul		139-757	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D012559	Schizophrenia

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

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Browse Branches

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