Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-24 @ 8:21 AM
Study NCT ID:
NCT02093858
Status:
UNKNOWN
Last Update Posted:
2014-03-21
First Post:
2014-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Mechanism of TCF7L2 and SLC30A8 on Antipsychotic-induced Metabolic Syndrome
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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 212}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-20', 'studyFirstSubmitDate': '2014-03-20', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change of serum insulin', 'timeFrame': '24 weeks'}], 'primaryOutcomes': [{'measure': 'Change in weight and blood glucose', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Change of the blood pressure and blood lipid', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Metabolic Syndrome'], 'conditions': ['Schizophrenia', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Almost all of antipsychotics can induce metabolic syndrome,Genetic factors play a key role in the development of metabolic syndrome,TCF7L2 and SLC30A8 are strongestly correlated with metabolic syndrome.Moreover,Antipsychotics have an effect on the expression of TCF7L2 and SLC30A8 genes.It indicates the variations of TCF7L2 and SLC30A8 play an important part in the development of antipsychotics-induced metabolic syndrome.', 'detailedDescription': '* In this study, we will determine the effect of olanzapine on the expression of TCF7L2 and SLC30A8.\n* The relationship of the polymorphism of TCF7L2 and SLC30A8 with antipsychotic-induced metabolic syndrome in schizophrenia patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All participants met the Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-IV) criteria for first episode schizophrenia.All of the patients and their familier are know of the study and sign the informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of first episode schizophrenia\n* Must be able to swallow tablets\n* Take only one antipsychotics\n\nExclusion Criteria:\n\n* liver or renal or cardiovascular diseases\n* pregnant or lactating women\n* drug and alcohol dependence'}, 'identificationModule': {'nctId': 'NCT02093858', 'briefTitle': 'The Mechanism of TCF7L2 and SLC30A8 on Antipsychotic-induced Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'The Mechanism of TCF7L2 and SLC30A8 on Antipsychotic-induced Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'RRW'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'olanzapine', 'description': '15-25mg/day for 24 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'contacts': [{'name': 'Renrong Wu, PhD', 'role': 'CONTACT', 'email': 'wurenrong2013@163.com.cn', 'phone': '86-15874179855'}, {'name': 'Renrong Wu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mental Health Institute', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'RenRong Wu, PhD', 'role': 'CONTACT', 'email': 'wurenrong2013@163.com', 'phone': '0731-85554052'}], 'overallOfficials': [{'name': 'Wu R Rong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central South University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Renrong Wu', 'investigatorAffiliation': 'Central South University'}}}}