Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT04956094
Status:
WITHDRAWN
Last Update Posted:
2025-06-06
First Post:
2021-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GGT and Uric Acid to Predict Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], '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': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Principal Investigator left the institution.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2021-06-30', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients diagnosed with gestational diabetes mellitus', 'timeFrame': '24-28 weeks', 'description': 'Diagnosis of gestational diabetes mellitus (GDM) via oral glucose tolerance testing (Carpenter and Coustan criteria)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'Screening', 'Gamma Glutamyl Transferase', 'Serum Uric Acid', 'Sensitivity', 'Specificity', 'Predictive Value'], 'conditions': ['Gestational Diabetes']}, 'descriptionModule': {'briefSummary': 'Gestational Diabetes Mellitus (GDM) is a common metabolic complication of pregnancy defined as new onset hyperglycemia during gestation. GDM conveys significant risk of morbidity and mortality for both mother and infant. An estimated 268,900 infants were born to mothers with GDM in the USA, accounting for approximately 6.9% of births. Although individual correlations have been found between elevated GGT and uric acid levels and later development of GDM, no research has established and validated combined criteria for GGT and uric acid levels that would lead to their use in identifying women at high risk of GDM in the first trimester.\n\nCentral Hypothesis: Serum GGT and serum uric acid collected between \\>9-14.0 weeks gestation will be significantly elevated in women who later develop GDM compared to those who do not. Combined analysis of serum uric acid and GGT levels within the first trimester allows for accurate prediction of the development of GDM.\n\nStudy population includes women between 9-14 weeks gestation undergoing a standard first trimester blood draw. Additional blood will be drawn during the standard blood draw to assess GGT and uric acid levels. Research participants will be tracked afterwards to determine whether they tested positive for gestational diabetes during the standard testing process which typically occurs at 24-28 weeks gestation. The data will then be analyzed to estimate the sensitivity, specificity, positive and negative predictive values of the first trimester GGT and uric acid tests. The GGT and uric acid levels which maximize the area under the receiver-operator characteristic curve will be identified.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women between \\> 9 weeks and \\< 14 and 0 weeks gestation presenting to the OB clinic for prenatal care', 'genderDescription': 'Pregnant Females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between \\> 9 weeks and \\< 14.0 weeks gestation\n\nExclusion Criteria:\n\n* Known history of or current diagnosis of type I or type II diabetes mellitus\n* Known liver disease\n* Known kidney disease\n* Known history of or current diagnosis of gout\n* Known history of alcoholism or current alcohol use\n* Multiple gestation\n* \\< 18 years of age'}, 'identificationModule': {'nctId': 'NCT04956094', 'acronym': 'GGTUAGDM', 'briefTitle': 'GGT and Uric Acid to Predict Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Mount Carmel Health System'}, 'officialTitle': 'Association of Elevated Serum Gamma Glutamyl Transferase (GGT) and Uric Acid at 9-14 Weeks Gestation With the Development of Gestational Diabetes Mellitus (GDM)', 'orgStudyIdInfo': {'id': '210412-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'First Trimester Prenatal Visit', 'description': 'Women attending an initial first trimester prenatal visit who will be undergoing a standard blood draw.', 'interventionNames': ['Diagnostic Test: GGT/Uric Acid']}], 'interventions': [{'name': 'GGT/Uric Acid', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standard laboratory blood testing for GGT and uric acid levels.', 'armGroupLabels': ['First Trimester Prenatal Visit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mount Carmel Health System', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'James Dombroski, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mount Carmel Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data with others. Study data may be requested from the sponsor or investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Carmel Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mount Carmel Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}