Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT01243034
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2010-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Waist Circumference Measurements in Schizophrenic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2011-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2010-11-17', 'studyFirstSubmitQcDate': '2010-11-17', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07-31', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Waist Circumference Measurements', 'Schizophrenia', 'Cardiovascular Risk Factor']}, 'descriptionModule': {'briefSummary': "The prevalence of metabolic syndrome(MS) among pt's with schizophrenia has been reported to be high, ranging from 24 to 43% in males and 27 to 52% in females. Schizophrenic patients with MS have an increased incidence of DM, coronary heart disease and increased mortality from cardiovascular diseases. Central adiposity is highly correlated with the presence of hypertension, coronary heart disease, type 2 diabetes, and increased mortality risk. Waist circumference(WC) is a better indicator of abdominal obesity and a better predictor of CVD than either BMI or waist-to-hip ratio. However, currently there is no standard location for the measurement of WC.\n\nObjectives: 1. To compare the magnitude of WC measured at 3 sites ( immediately above the iliac crest, midpoint between the lowest rib and the iliac crest , umbilical level) in males and females.\n\n2\\. To examine the correlation of WC with Triglyceride, cholesterol, HDL, LDL and glucose."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'schizophrenia outpatients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients with schizophrenia or schizoaffective disorder (DSM-IV 295) age 18 till 65 years old.\n\n * Body weight change less than 1 kg in previous one month before index date.\n\nExclusion Criteria:\n\n* • Patients with a previous hyperlipidemia diagnosis or antilipemic prescription during the preceding 30 days.\n\n * Patients received any anti-hypertensives or oral hypoglycemic agents.\n * Pregnant or breast-feeding women.'}, 'identificationModule': {'nctId': 'NCT01243034', 'briefTitle': 'Waist Circumference Measurements in Schizophrenic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Changhua Christian Hospital'}, 'officialTitle': 'Variability of Waist Circumference Measurements at 3 Sites and Its Relationship With Cardiovascular Risk Factors in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': '100717'}}, 'contactsLocationsModule': {'locations': [{'zip': '500', 'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Changhua Christian Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhua Christian Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'attending psychiatrist', 'investigatorFullName': 'Cheng-Chen Chang', 'investigatorAffiliation': 'Changhua Christian Hospital'}}}}