Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-02-26 @ 7:51 PM
Study NCT ID:
NCT03029702
Status:
COMPLETED
Last Update Posted:
2024-11-29
First Post:
2017-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D011254', 'term': 'Pregnancy in Diabetics'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}, {'id': 'D005905', 'term': 'Glyburide'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'feghalim@upmc.edu', 'phone': '412 641 1000', 'title': 'Maisa Feghali', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Throughout study participation ~ 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Individualized Treatment', 'description': 'Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Women Who Are Eligible, Screened, Enroll and Remain in the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. 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Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9', 'groupIds': ['OG000'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, an average of 16 weeks', 'description': 'Proportion of women who are eligible, screened, enrolled and remain in the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Proportion of Participants Who Report Suitability of the Study Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}, {'id': 'OG001', 'title': 'Individualized Treatment', 'description': 'Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8', 'groupIds': ['OG000'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, an average of 16 weeks', 'description': 'Suitability of the study procedures and interventions to participants assessed through one-on-one qualitative interview', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Consistent GDM Mechanism Before and and After Treatment Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}, {'id': 'OG001', 'title': 'Individualized Treatment', 'description': 'Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9', 'groupIds': ['OG000'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks after treatment initiation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Women Who Remain on Same Treatment During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}, {'id': 'OG001', 'title': 'Individualized Treatment', 'description': 'Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9', 'groupIds': ['OG000'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, an average of 16 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Glucose Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}, {'id': 'OG001', 'title': 'Individualized Treatment', 'description': 'Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8', 'groupIds': ['OG000'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Delivery', 'description': '\\>50% fasting below 95 and 1 hour postprandial \\< 140 during the 4 weeks before delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Who Deliver by Primary Cesarean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}, {'id': 'OG001', 'title': 'Individualized Treatment', 'description': 'Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6', 'groupIds': ['OG000'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Who Developed Hypertensive Diseases in Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}, {'id': 'OG001', 'title': 'Individualized Treatment', 'description': 'Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8', 'groupIds': ['OG000'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Birthweight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}, {'id': 'OG001', 'title': 'Individualized Treatment', 'description': 'Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '332.5', 'spread': '376.7', 'groupId': 'OG000'}, {'value': '3445.4', 'spread': '627.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Delivery', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Lean Body Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}, {'id': 'OG001', 'title': 'Individualized Treatment', 'description': 'Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}], 'timeFrame': 'Within 72 hours of delivery', 'reportingStatus': 'POSTED', 'populationDescription': 'Unable to collect neonatal data due to lack of staffing availability'}, {'type': 'SECONDARY', 'title': 'Cord Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}, {'id': 'OG001', 'title': 'Individualized Treatment', 'description': 'Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}], 'timeFrame': 'Delivery', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples unavailable for analysis due to freezer storage malfunction'}, {'type': 'SECONDARY', 'title': 'Cord Blood C-peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}, {'id': 'OG001', 'title': 'Individualized Treatment', 'description': 'Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}], 'timeFrame': 'Delivery', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples unavailable for analysis due to freezer storage malfunction'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}, {'id': 'FG001', 'title': 'Individualized Treatment', 'description': 'Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}, {'id': 'BG001', 'title': 'Individualized Treatment', 'description': 'Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.\n\nInsulin: Insulin will be used for GDM treatment\n\nGlyburide: Glyburide will be used for GDM treatment\n\nMetformin: Metformin will be used for GDM treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.90', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '30.91', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '30.9', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', '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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', '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': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-01', 'size': 752549, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-06T13:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "Study team members assessing delivery outcomes will be masked to the participant's study assignment"}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot randomized controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2017-01-19', 'resultsFirstSubmitDate': '2024-10-16', 'studyFirstSubmitQcDate': '2017-01-23', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-06', 'studyFirstPostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Women Who Are Eligible, Screened, Enroll and Remain in the Study', 'timeFrame': 'Through study completion, an average of 16 weeks', 'description': 'Proportion of women who are eligible, screened, enrolled and remain in the study'}, {'measure': 'Proportion of Participants Who Report Suitability of the Study Procedures', 'timeFrame': 'Through study completion, an average of 16 weeks', 'description': 'Suitability of the study procedures and interventions to participants assessed through one-on-one qualitative interview'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With Consistent GDM Mechanism Before and and After Treatment Initiation', 'timeFrame': '2 weeks after treatment initiation'}, {'measure': 'Proportion of Women Who Remain on Same Treatment During Study', 'timeFrame': 'Through study completion, an average of 16 weeks'}, {'measure': 'Maternal Glucose Control', 'timeFrame': 'Delivery', 'description': '\\>50% fasting below 95 and 1 hour postprandial \\< 140 during the 4 weeks before delivery'}, {'measure': 'Proportion of Participants Who Deliver by Primary Cesarean', 'timeFrame': 'Delivery'}, {'measure': 'Proportion of Participants Who Developed Hypertensive Diseases in Pregnancy', 'timeFrame': 'Delivery'}, {'measure': 'Birthweight', 'timeFrame': 'Delivery'}, {'measure': 'Neonatal Lean Body Mass', 'timeFrame': 'Within 72 hours of delivery'}, {'measure': 'Cord Blood Glucose', 'timeFrame': 'Delivery'}, {'measure': 'Cord Blood C-peptide', 'timeFrame': 'Delivery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gestational diabetes', 'Diabetes in pregnancy', 'Insulin resistance', 'Insulin secretion deficiency'], 'conditions': ['Gestational Diabetes', 'Diabetes, Gestational', 'Pregnancy in Diabetes']}, 'descriptionModule': {'briefSummary': "Gestational diabetes (GDM) is a significant clinical and public health burden, affecting over 400,000 pregnant women in the United States each year. Without adequate treatment, women with GDM and their infants are at risk for substantial morbidity. Because of this, experts recommend treatment focused on normalization of hyperglycemia to improve outcomes. However, providers have limited capacity to predict which treatment will achieve glycemic goals. This results in a choice based on provider and patient preference and a trial and error approach, which can create delays in glycemic control within the short (8-10 weeks) window between diagnosis and delivery. Maternal and fetal morbidity may be related to a mismatch between glycemic pathophysiology and the mechanism of action of glucose-lowering agents. In fact, GDM is heterogeneous, with predominant insulin resistance (IR) in 50%, insulin secretion deficit (ISD) in 30%, and a combination of both in 20% of women as underlying mechanisms of hyperglycemia. This variation in GDM pathophysiology and clinical outcomes supports the use of an individualized treatment approach. The overall goal of this project is to investigate an individualized treatment approach for GDM where treatment is based on each woman's GDM mechanism. The study will employ the same treatment in both arms, but choice of treatment will differ based on study arm (matched or unmatched to GDM mechanism)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant women beyond 24 weeks of gestation who are scheduled for a 3-hour oral glucose tolerance test.\n\nExclusion Criteria:\n\n* Fetal anomaly\n* Pregestational diabetes\n* GDM diagnosis without a 3-hour OGTT\n* Multifetal gestation\n* Treatment with non-inhaled steroids within 7 days\n* Allergy to glyburide, metformin or sulfa\n* History of severe pulmonary (pulmonary requirement for oxygen therapy or daily treatment for restrictive of obstructive pulmonary disease)\n* Hepatic (LFT's greater than two times of upper normal range)\n* Renal (serum creatinine higher than 1.2 mg/dL) disease\n* History of heart failure or myocardial infarction"}, 'identificationModule': {'nctId': 'NCT03029702', 'acronym': 'MATCh-GDM', 'briefTitle': 'Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'PRO16100499'}, 'secondaryIdInfos': [{'id': 'K23HD092893', 'link': 'https://reporter.nih.gov/quickSearch/K23HD092893', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.', 'interventionNames': ['Drug: Insulin', 'Drug: Glyburide', 'Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Individualized Treatment', 'description': 'Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.', 'interventionNames': ['Drug: Insulin', 'Drug: Glyburide', 'Drug: Metformin']}], 'interventions': [{'name': 'Insulin', 'type': 'DRUG', 'description': 'Insulin will be used for GDM treatment', 'armGroupLabels': ['Individualized Treatment', 'Usual Care']}, {'name': 'Glyburide', 'type': 'DRUG', 'description': 'Glyburide will be used for GDM treatment', 'armGroupLabels': ['Individualized Treatment', 'Usual Care']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin will be used for GDM treatment', 'armGroupLabels': ['Individualized Treatment', 'Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee Womens Hospital of UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Maisa N Feghali, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maisa N. Feghali, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Maisa N. Feghali, MD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}