Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-04 @ 1:14 PM
Study NCT ID:
NCT03436992
Status:
COMPLETED
Last Update Posted:
2025-02-17
First Post:
2018-02-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Estrogen and Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077185', 'term': 'Resveratrol'}], 'ancestors': [{'id': 'D000081225', 'term': 'Stilbestrols'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D059808', 'term': 'Polyphenols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ryharris@augusta.edu', 'phone': '706-721-5483', 'title': 'Dr. Ryan Harris', 'organization': 'Augusta University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline to Post testing (~2 weeks)', 'description': "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.", 'eventGroups': [{'id': 'EG000', 'title': 'T1M Women', 'description': 'women with type 1 diabetes', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Controls', 'description': 'apparently healthy women', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'FMD/Shear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T1M Women', 'description': 'women with type 1 diabetes'}, {'id': 'OG001', 'title': 'Controls', 'description': 'apparently healthy women'}], 'classes': [{'title': 'Menses', 'categories': [{'measurements': [{'value': '0.182', 'spread': '0.068', 'groupId': 'OG000'}, {'value': '0.206', 'spread': '0.100', 'groupId': 'OG001'}]}]}, {'title': 'Late Follicular', 'categories': [{'measurements': [{'value': '0.155', 'spread': '0.059', 'groupId': 'OG000'}, {'value': '0.219', 'spread': '0.110', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '~ 2 weeks. Acquired at Menses and Late Follicular phase.', 'description': 'Flow-Mediated Dilation (FMD) controlled for shear', 'unitOfMeasure': '%/s^-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T1M Women', 'description': 'women with type 1 diabetes'}, {'id': 'FG001', 'title': 'Controls', 'description': 'apparently healthy women'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'These results were based on a subset (n=57) of the total enrollment of 143.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'T1M Women', 'description': 'women with type 1 diabetes'}, {'id': 'BG001', 'title': 'Controls', 'description': 'apparently healthy women'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '6', 'groupId': 'BG000'}, {'value': '24', 'spread': '6', 'groupId': 'BG001'}, {'value': '25', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '163.5', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '165.4', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '164.3', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '72.8', 'spread': '17.6', 'groupId': 'BG000'}, {'value': '68.4', 'spread': '15.8', 'groupId': 'BG001'}, {'value': '70.9', 'spread': '16.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '24.5', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '26.0', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'MAP', 'classes': [{'categories': [{'measurements': [{'value': '87', 'spread': '8', 'groupId': 'BG000'}, {'value': '83', 'spread': '7', 'groupId': 'BG001'}, {'value': '85', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CRP', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '1.2', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '3.6', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'C-Reactive Protein', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'TC', 'classes': [{'categories': [{'measurements': [{'value': '178', 'spread': '41', 'groupId': 'BG000'}, {'value': '163', 'spread': '35', 'groupId': 'BG001'}, {'value': '171', 'spread': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total Cholesterol', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HDL', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '17', 'groupId': 'BG000'}, {'value': '53', 'spread': '13', 'groupId': 'BG001'}, {'value': '56', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LDL', 'classes': [{'categories': [{'measurements': [{'value': '98', 'spread': '42', 'groupId': 'BG000'}, {'value': '88', 'spread': '39', 'groupId': 'BG001'}, {'value': '94', 'spread': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'TRIG', 'classes': [{'categories': [{'measurements': [{'value': '76', 'spread': '45', 'groupId': 'BG000'}, {'value': '63', 'spread': '28', 'groupId': 'BG001'}, {'value': '70', 'spread': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Triglycerides', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'TC/HDL ratio', 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '3.2', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '3.2', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '5.2', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '7.1', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-14', 'size': 988599, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-27T12:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2018-02-13', 'resultsFirstSubmitDate': '2024-11-18', 'studyFirstSubmitQcDate': '2018-02-13', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-27', 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FMD/Shear', 'timeFrame': '~ 2 weeks. Acquired at Menses and Late Follicular phase.', 'description': 'Flow-Mediated Dilation (FMD) controlled for shear'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Estrogen, Diabetes'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'Diabetes has recently been referred to as "the epidemic of the 21st century". The reason why women with type 1 diabetes have a 2-3 fold greater risk of cardiovascular disease (CVD) compared to men with type 1 diabetes is unknown.The purpose of this study is to investigate whether or not estrogen contributes to vascular dysfunction in premenopausal women with diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both men and premenopausal\n* Normal menstrual cycle interval of 25-35 days for at least 3 previous cycles\n* All races\n* Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)\n\nExclusion Criteria:\n\n* Clinical diagnosis of hepatic, cardiovascular, or renal disease\n* Uncontrolled Diabetes (HbA1c\\>9%)\n* Diabetic complications (i.e. macrovascular, microvascular, or autonomic)\n* Proteinuria\n* Uncontrolled Hypertension (\\>140/90 mmHg on therapy)\n* Hormonal use of birth control (past 3 months)\n* Pregnancy\n* Oligomenorrhea\n* Direct vasoactive medications (i.e. nitrates)\n* Anti-estrogens (i.e. SERMs)\n* Plycystic ovarian syndrome (defined by NIH guidelines-hyperandrogenic anovulation)\n* Undetectable Anti-Mullerian Hormone (AMH) following screening'}, 'identificationModule': {'nctId': 'NCT03436992', 'briefTitle': 'Estrogen and Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'Estrogen-Mediated Impairments of Vascular Health in Diabetes', 'orgStudyIdInfo': {'id': 'E2 and D'}, 'secondaryIdInfos': [{'id': '1R01HL137087-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL137087-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Women with type 1 diabetes', 'description': 'Women with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (Antioxidant cocktail, Resveratrol, or placebo)', 'interventionNames': ['Dietary Supplement: Antioxidant Cocktail', 'Dietary Supplement: Resveratrol', 'Other: Placebo']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy control women', 'description': 'Healthy women who participate will receive no intervention and serve as controls.'}, {'type': 'EXPERIMENTAL', 'label': 'Men with type 1 diabetes', 'description': 'Men with type 1 diabetes will be randomly assigned to 1 of the 3 interventions (AOX cocktail, Resveratrol, or placebo)', 'interventionNames': ['Dietary Supplement: Antioxidant Cocktail', 'Dietary Supplement: Resveratrol', 'Other: Placebo']}], 'interventions': [{'name': 'Antioxidant Cocktail', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin C, Vitamin E, alpha lipoic acid', 'armGroupLabels': ['Men with type 1 diabetes', 'Women with type 1 diabetes']}, {'name': 'Resveratrol', 'type': 'DIETARY_SUPPLEMENT', 'description': '1500 mg trans-resveratrol', 'armGroupLabels': ['Men with type 1 diabetes', 'Women with type 1 diabetes']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'placebo', 'armGroupLabels': ['Men with type 1 diabetes', 'Women with type 1 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Prevention Institute', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'overallOfficials': [{'name': 'Ryan Harris, PhD, CES', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Augusta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ryan Harris', 'investigatorAffiliation': 'Augusta University'}}}}