Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT05386927
Status:
UNKNOWN
Last Update Posted:
2023-10-19
First Post:
2022-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Diagnosis of GDM by Multiomics
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, urine and saliva from pregnant women will be collected for testing'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2022-05-15', 'studyFirstSubmitQcDate': '2022-05-19', 'lastUpdatePostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Salivary metabolomics', 'timeFrame': 'First trimester (9-14 gestational weeks)', 'description': 'The differential salivary metabolism molecules in saliva were detected by the self-developed detection chip, and the markers related to GDM in early pregnancy were screened. Specimens were collected during the first trimester.'}, {'measure': 'Serum lipidomics', 'timeFrame': 'First trimester (9-14 gestational weeks)', 'description': 'The differential serum lipid molecules in serum were detected by the self-developed detection chip, and the markers related to GDM in early pregnancy were screened. Specimens were collected during the first trimester.'}, {'measure': 'Urine metabolomics', 'timeFrame': 'First trimester (9-14 gestational weeks)', 'description': 'The differential urine metabolism molecules in urine were detected by the self-developed detection chip, and the markers related to GDM in early pregnancy were screened. Specimens were collected during the first trimester.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Gestational diabetes mellitus (GDM) is prone to cause a variety of adverse pregnancy outcomes, and has potential harm to the short-term and long-term health of both mothers and infants. However, its diagnosis mainly relies on oral glucose tolerance test (OGTT) at 24-28 weeks of gestation, so it is often diagnosed in the second and third trimester, and may be too late to intervene. Therefore, advancing the diagnostic window period of GDM is the key to the prevention and treatment of GDM and its complications. It is urgent to establish a new technology for the early diagnosis and screening of GDM with high detection rate and accuracy. Based on literature survey and previous studies, this study found that the combined analysis of metabolomics and lipidomics may have broad clinical application prospects in the early diagnosis and screening of GDM. It is hoped that a set of new techniques based on multi-omics for early diagnosis and screening of GDM can be constructed, providing a feasible and effective tool for early detection and treatment of GDM in clinical.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This project intends to recruit pregnant women who go to the research center for routine prenatal examination and OGTT screening.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Plan to have routine prenatal examinations and give birth in the research center\n* First trimester\n* Singleton pregnancy\n* Without pregnancy complications\n* Willing to cooperate with the hospital to follow up\n\nExclusion Criteria:\n\n* Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, AIDS, etc.\n* Fetus has a known deformity or genetic defects\n* Incomplete clinical data'}, 'identificationModule': {'nctId': 'NCT05386927', 'briefTitle': 'Early Diagnosis of GDM by Multiomics', 'organization': {'class': 'OTHER', 'fullName': "Women's Hospital School Of Medicine Zhejiang University"}, 'officialTitle': 'Clinical Study of a New Technology System for Early Diagnosis and Screening of GDM Based on Multiomics', 'orgStudyIdInfo': {'id': 'IRB-20210293-R'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GDM group', 'description': 'Pregnant women with positive OGTT results at 24-28 gestational weeks', 'interventionNames': ['Other: Questionnaire survey and specimen collection']}, {'label': 'Control group', 'description': 'Pregnant women with negative OGTT results at 24-28 gestational weeks, and had baseline data that matched those in the GDM group', 'interventionNames': ['Other: Questionnaire survey and specimen collection']}], 'interventions': [{'name': 'Questionnaire survey and specimen collection', 'type': 'OTHER', 'description': 'A questionnaire survey was conducted when pregnant women were enrolled in the first trimester, and blood, urine, saliva and other specimens were collected.', 'armGroupLabels': ['Control group', 'GDM group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhaoxia Liang, Prof.', 'role': 'CONTACT', 'email': 'xiaozaizai@zju.edu.cn', 'phone': '86571-89992115'}], 'facility': "Women's Hospital School Of Medicine Zhejiang University", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Zhaoxia Liang, Prof.', 'role': 'CONTACT', 'email': 'xiaozaizai@zju.edu.cn', 'phone': '86571-89992115'}], 'overallOfficials': [{'name': 'Zhaoxia Liang, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Women's Hospital School Of Medicine Zhejiang University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Women's Hospital School Of Medicine Zhejiang University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}