Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-02-28 @ 11:15 AM
Study NCT ID:
NCT00569504
Status:
UNKNOWN
Last Update Posted:
2009-06-12
First Post:
2007-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'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'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood sampling'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-06-11', 'studyFirstSubmitDate': '2007-12-06', 'studyFirstSubmitQcDate': '2007-12-06', 'lastUpdatePostDateStruct': {'date': '2009-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'metabolic syndrome', 'timeFrame': 'cross-sectional'}], 'secondaryOutcomes': [{'measure': 'each factor of metabolic syndrome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'antipsychotics', 'metabolic syndrome', 'prevalence'], 'conditions': ['Metabolic Syndrome', 'Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the cross-sectional prevalence of the metabolic syndrome in patients with schizophrenia taking antipsychotics.', 'detailedDescription': 'Schizophrenic patients taking any kind of antipsychotics for at least 1 year at the Seoul National Hospital will be participated in this study.\n\nwe are planning to enroll approximately 1000 patients with schizophrenia.\n\nFor each subject\n\n* abdominal circumference\n* body mass index\n* lipid profile : TG, HDL-chlo, total chol\n* systolic/diastolic blood pressure\n* fasting blood glucose will be measured.\n\nwe will calculate the rates of patients who meet the criteria for the Metabolic syndrome.\n\n1. Abdominal obesity : absolute criteria\n2. 2 or more of followings\n\n 1. Triglyceride ≥ 150mg/dL or ongoing treatment\n 2. HDL-cholesterol \\< 40mg/dL (men) HDL-cholesterol \\< 50mg/dL (female) or ongoing treatment\n 3. Hypertension 130mmHg ≥ systolic 85mmHg ≥ diastolic or ongoing treatment\n 4. FBS ≥ 100mg/dL or previous diagnosis of type II DM'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'DSM-IV diagnosis of schizophrenia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients taking a same antipsychotics at least more than one year\n* schizophrenia or schizoaffective disorder\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT00569504', 'briefTitle': 'Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Seoul National Hospital'}, 'officialTitle': 'Prevalence of the Metabolic Syndrome in Patients With Schizophrenia Taking Antipsychotics', 'orgStudyIdInfo': {'id': 'snh001'}, 'secondaryIdInfos': [{'id': 'PMSPSTA'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'A, observatoin', 'description': 'inpatients and outpatients in Seoul National Hospital'}]}, 'contactsLocationsModule': {'locations': [{'zip': '139-757', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Shi Hyun Kang, M.D.', 'role': 'CONTACT', 'email': 'drshe@hanmail.net', 'phone': '82-2-2204-0326'}], 'facility': 'Seoul National Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Shi Hyun Kang, M.D.', 'role': 'CONTACT', 'email': 'drshe@hanmail.net', 'phone': '82-2-2204-0326'}], 'overallOfficials': [{'name': 'Jong-il Lee, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Korea Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Shi Hyun Kang', 'oldOrganization': 'Seoul National Hospital'}}}}