Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-03-05 @ 3:31 AM
Study NCT ID:
NCT02708394
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2016-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Mechanisms of Antipsychotic-induced Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077152', 'term': 'Olanzapine'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-28', 'size': 596776, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-02-06T15:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-27', 'studyFirstSubmitDate': '2016-03-05', 'studyFirstSubmitQcDate': '2016-03-09', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in DNA methylation', 'timeFrame': 'Baseline (day 1) to endpoint of intervention (day 7)', 'description': 'Change in peripheral tissue candidate gene methylation will be measured in the olanzapine intervention group compared to placebo'}], 'secondaryOutcomes': [{'measure': 'Change in protein levels', 'timeFrame': 'Baseline (day 1) to endpoint of intervention (day 7)', 'description': 'Change in peripheral tissue candidate protein levels will be measured in the olanzapine intervention group compared to placebo'}, {'measure': 'Change in protein activity', 'timeFrame': 'Baseline (day 1) to endpoint of intervention (day 7)', 'description': 'Change in peripheral tissue candidate protein phosphorylation will be measured in the olanzapine intervention group compared to placebo'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adverse Effect of Other Antipsychotics and Neuroleptics', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'This study will investigate the molecular mechanisms of atypical-antipsychotic induced insulin resistance. This will be accomplished by administering olanzapine or placebo to healthy subjects for 7 days and analyzing genetic and protein changes in peripheral tissues known to play an important role in insulin resistance pathophysiology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'We will include persons that meet the following criteria:\n\n1. 21-45 years old\n2. BMI 18.5-24.9kg/m2\n3. No history of drug or alcohol dependence or abuse\n4. No current or past history of psychiatric or neurologic disease\n5. minimal exercise routine prior or during study (light walking allowed)\n6. Normal liver function tests\n7. minimal alcohol intake (\\<1 drink per day).\n\nThe following persons will be excluded:\n\n1. Has 1st degree relative with diabetes (I or II)\n2. current or re-cent nicotine intake\n3. presence of organic/physical disease that could affect glucose\n4. currently taking prescription or over-the-counter medications that could affect glucose\n5. currently pregnant or lactating\n6. unwilling to take acceptable birth control method\n7. current or previous exposure to antipsychotics\n8. history of unstable weight\n9. personal or family history of cardiac arrhythmias or seizures\n10. current or past history of eating disorder(s) or restricted diet\n11. allergy to lidocaine or drug excipients\n12. history of difficulty with intravenous line placement\n13. history of fainting.'}, 'identificationModule': {'nctId': 'NCT02708394', 'briefTitle': 'Molecular Mechanisms of Antipsychotic-induced Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Molecular Mechanisms of Antipsychotic-induced Insulin Resistance in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'MMAAPWSU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'olanzapine', 'description': 'Atypical antipsychotic', 'interventionNames': ['Drug: olanzapine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo comparator', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'olanzapine', 'type': 'DRUG', 'otherNames': ['Zyprexa'], 'description': 'atypical antipsychotic', 'armGroupLabels': ['olanzapine']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo control', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University Clinical Research Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kyle Jon Burghardt, Pharm.D.', 'investigatorAffiliation': 'Wayne State University'}}}}