Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 11:29 PM
Study NCT ID:
NCT06753734
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-31
First Post:
2024-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Prediction of Gestational Diabetes in High-risk Women Based on Breath Metabolomics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-12-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2024-12-23', 'studyFirstSubmitQcDate': '2024-12-23', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of gestational diabetes mellitus', 'timeFrame': '24-28 weeks gestation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Diabetes']}, 'descriptionModule': {'briefSummary': 'This study aim to develope novel breath markers of gestational diabetes through a prospective high-risk population cohort study and achieve early prediction of gestational diabetes based on an interpretable machine learning model.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population in this study include pregnant women aged 18-55 years and at 11-14 weeks gestation with at least one risk factor for GDM', 'healthyVolunteers': True, 'eligibilityCriteria': 'Eligibility Criteria\n\n* 18-55 years old\n* 11-14 weeks of pregnancy\n* at least one risk factor for GDM\n* signed a written informed consent\n\nExclusion Criteria:\n\n* Diabetes mellitus or abnormal glucose metabolism before pregnancy\n* Hyperemesis gravidarum (urine ketone positive))\n* Thyroid dysfunction\n* Asthmatic patients\n* Hypertensive diseases that are difficult to control\n* Severe hepatic and renal insufficiency or severe electrolyte disturbance\n* Malignant tumor\n* Acute inflammation\n* lung disease\n* Patients with gastritis, duodenum and other digestive system diseases\n* Those with upper respiratory or oral problems who cannot cooperate with expiratory collection\n* smoker'}, 'identificationModule': {'nctId': 'NCT06753734', 'briefTitle': 'Early Prediction of Gestational Diabetes in High-risk Women Based on Breath Metabolomics', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Central Hospital of Gynecology Obstetrics'}, 'officialTitle': 'A Cohort Study in Women at High Risk for Gestational Diabetes Based on Breath Metabolomics', 'orgStudyIdInfo': {'id': '2024KY081'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gestational Diabetes Group'}, {'label': 'control group'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Central Hospital of Gynecology Obstetrics', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Central Hospital of Gynecology Obstetrics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}