Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-05 @ 1:33 AM
Study NCT ID:
NCT01477918
Status:
UNKNOWN
Last Update Posted:
2011-11-23
First Post:
2011-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Metabolic Syndrome in Patients With Schizophrenia in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'lastUpdateSubmitDate': '2011-11-22', 'studyFirstSubmitDate': '2011-11-20', 'studyFirstSubmitQcDate': '2011-11-22', 'lastUpdatePostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of metabolic syndrome (MetS)', 'description': 'MetS will be diagnosed according to NCEP ATP III with the Asian-Pacific abdominal obesity criterion (≥90 cm in men, ≥85 cm in women)\n\n3 or more of the following criteria\n\n1. fasting plasma glucose \\>= 100 mg/dl or drug use to treat elevated glucose\n2. serum triglyceride (TG) \\>= 150 mg/dl or drug use to treat elevated TG\n3. HDL cholesterol level \\< 40mg /dl in males, \\< 50 mg/dl in female or drug use to treat low HDL\n4. Systolic BP \\>=130 mmHg, diastolic BP \\>=85 or drug use to treat hypertension\n5. Abdominal obesity : above described'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prevalence', 'Korea'], 'conditions': ['Schizophrenia', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the prevalence of the Metabolic syndrome(MetS) in Korean patients with schizophrenia.\n\nPrimary objective:\n\n• To investigate the prevalence of the MetS in Korean patients with schizophrenia\n\nSecondary objectives:\n\n• 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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include all patients that met the following criteria:\n\n1. Diagnosis of schizophrenia according to DSM-IV-TR\n2. Age between 18-65 years\n\nTo 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.\n\n1. 20 centers were selected to provide the representative results of prevalence of the MetS\n2. 50 patients in each center were consecutively enrolled', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of schizophrenia according to DSM-IV-TR\n* Age between 18-65 years'}, 'identificationModule': {'nctId': 'NCT01477918', 'briefTitle': 'Prevalence of Metabolic Syndrome in Patients With Schizophrenia in Korea', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'orgStudyIdInfo': {'id': 'MetS_1005'}}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Yeon-Ho Joo, Ph. D.', 'role': 'CONTACT', 'email': 'jooyh@amc.seoul.kr', 'phone': '82-2-3010-3412'}], 'facility': 'Asan medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yeon-Ho Joo, Ph.D.', 'role': 'CONTACT', 'email': 'jooyh@amc.seoul.kr', 'phone': '82-2-3010-3412'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yeon-Ho Joo', 'investigatorAffiliation': 'Asan Medical Center'}}}}