Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-03-31 @ 2:31 AM
Study NCT ID:
NCT03771066
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2018-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bisphenol A and Muscle Insulin Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D065817', 'term': 'Congenital Microtia'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C006780', 'term': 'bisphenol A'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-01', 'size': 529968, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_003.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2019-11-08T11:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study will be a double-blinded study. Research staff collecting data and participants will not know treatment allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "This experimental study is a 2-group randomized, clinical trial comparing a 4-day energy balance diet plus oral BPA consumption at 50 ug/kg body weight (Diet+BPA) vs. 4-day energy balance diet plus oral placebo consumption (Diet+No BPA). Forty participants will be randomized to Diet+BPA and Diet+No BPA and will reside in a supervised environment at Cal Poly's sleep research facilities for 6 days (2-day baseline run-in, followed by 4-day treatment). Main outcome measures (muscle insulin sensitivity and hepatic glucose suppression) will be assessed at baseline and treatment periods."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2018-12-06', 'studyFirstSubmitQcDate': '2018-12-07', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in rate of glucose disposal', 'timeFrame': 'Baseline and 4 days', 'description': 'Three hour euglycemic hyperinsulinemic clamp technique with stable glucose isotope infusion to determine rate of glucose disposal'}, {'measure': 'Change in rate of glucose appearance', 'timeFrame': 'Baseline and 4 days', 'description': 'Ninety minutes stable glucose isotope infusion to determine rate of hepatic glucose appearance'}], 'secondaryOutcomes': [{'measure': 'Change in concentration of insulin', 'timeFrame': 'Baseline and 4 days', 'description': 'Fasting blood sample for insulin concentration'}, {'measure': 'Change in concentration of glucose', 'timeFrame': 'Baseline and 4 days', 'description': 'Fasting blood sample for glucose concentration'}, {'measure': 'Change in concentration of c-peptide', 'timeFrame': 'Baseline and 4 days', 'description': 'Fasting blood sample for c-peptide concentration'}, {'measure': 'Change in concentration of proinsulin', 'timeFrame': 'Baseline and 4 days', 'description': 'Fasting blood sample for proinsulin'}, {'measure': 'Change in concentration of adiponectin', 'timeFrame': 'Baseline and 4 days', 'description': 'Fasting blood sample for adiponectin'}, {'measure': 'Change in concentration of 17-beta estradiol', 'timeFrame': 'Baseline and 4 days', 'description': 'Fasting blood sample for 17-beta estradiol'}, {'measure': 'Change in concentration of firmicutes', 'timeFrame': 'Baseline and 4 days', 'description': 'Fecal microbiome concentration of firmicutes'}, {'measure': 'Change in concentration of clostridia', 'timeFrame': 'Baseline and 4 days', 'description': 'Fecal microbiome concentration of clostridia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bisphenol A', 'diet'], 'conditions': ['Insulin Sensitivity', 'Glucose Metabolism Disorders', 'Microtia']}, 'descriptionModule': {'briefSummary': 'This study examine oral bisphenol A consumption on muscle insulin sensitivity and hepatic glucose suppression. Half of the participants will receive a diet plus BPA and the other half will receive a diet plus no bisphenol A.', 'detailedDescription': "Evidence linking bisphenol A exposure with diabetes risk remains mainly associative in nature, and mechanism linking bisphenol A to type 2 diabetes remains unclear. The investigator's preliminary data suggests that in young adults, single oral BPA consumption significantly decreased glucose, insulin, and C-Peptide responses to an oral glucose tolerance test, suggesting that immediate consumption of bisphenol A has an effect on muscle insulin sensitivity, hepatic glucose suppression and/or digestion and absorption to lower blood glucose, insulin, and C-Peptide concentrations. The present experimental study evaluating the effects of bisphenol A over several days on the pathogenesis of type 2 diabetes will directly assess each of these potential mechanisms using gold standard measures (euglycemic hyperinsulinemic clamp technique and hepatic glucose suppression with glucose stable isotope infusion, and fecal microbiota)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-dieting\n* sedentary (≤3 hour/week of aerobic exercise)\n* normal-weight (BMI = 18.5 to 24.9 kg/m2)\n* weight-stable for the previous 6 months\n* free of any metabolic or chronic disease\n* non-smoking, and sedentary\n\nExclusion Criteria:\n\n* Hemoglobin A1C based on the American Diabetes Association guidelines of 5.7 to 6.4% (Prediabetes) or \\>6.4% (Diabetes)\n* impaired glucose tolerance\n* type 1 diabetes\n* type 2 diabetes\n* colitis or any inflammatory bowel condition\n* neurologic or psychiatric conditions\n* smoking\n* special diets (e.g. vegetarian, low-carbohydrate, Paleolithic, etc.)\n* pregnant women or women trying to become pregnant'}, 'identificationModule': {'nctId': 'NCT03771066', 'briefTitle': 'Bisphenol A and Muscle Insulin Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'California Polytechnic State University-San Luis Obispo'}, 'officialTitle': 'Randomized Trial Examining Oral Consumption of Bisphenol A on Type 2 Diabetes Risk Markers', 'orgStudyIdInfo': {'id': '2018-149-CP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diet plus bisphenol A', 'description': 'Participants will receive a 4-day diet plus bisphenol A at 50 ug/kg body weight.', 'interventionNames': ['Behavioral: bisphenol A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a 4-day diet plus no bisphenol A.', 'interventionNames': ['Behavioral: Placebo']}], 'interventions': [{'name': 'bisphenol A', 'type': 'BEHAVIORAL', 'description': 'Vanilla wafer cookie with bisphenol A administered', 'armGroupLabels': ['Diet plus bisphenol A']}, {'name': 'Placebo', 'type': 'BEHAVIORAL', 'description': 'Vanilla wafer cookie with no bisphenol A', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93405', 'city': 'San Luis Obispo', 'state': 'California', 'country': 'United States', 'facility': 'California Polytechnic State University', 'geoPoint': {'lat': 35.28275, 'lon': -120.65962}}], 'overallOfficials': [{'name': 'Todd Hagobian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'California Polytechnic State University-San Luis Obispo'}, {'name': 'Hannah Brunner-Gaydos', 'role': 'STUDY_DIRECTOR', 'affiliation': 'California Polytechnic State University-San Luis Obispo'}]}, 'ipdSharingStatementModule': {'url': 'https://digitalcommons.calpoly.edu', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available within 6 months of study completion, and will be available indefinitely.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primary and secondary outcome measures will be made available.', 'accessCriteria': 'Data access will be freely available for download on the Cal Poly Digital Commons website. Requestors will be required to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California Polytechnic State University-San Luis Obispo', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Todd Hagobian', 'investigatorAffiliation': 'California Polytechnic State University-San Luis Obispo'}}}}