Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05142020
Status:
UNKNOWN
Last Update Posted:
2023-02-01
First Post:
2021-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers for Early Screening of Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, plasma, serum, urine, tissue (placenta and umbilical cord)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-31', 'studyFirstSubmitDate': '2021-06-13', 'studyFirstSubmitQcDate': '2021-11-18', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Significantly different metabolites at 8-10 gestational weeks', 'timeFrame': 'Gestatioanl weeks: 8-10 weeks', 'description': 'Metabolomics are used to screen out significant different metabolites. Specific metabolites indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.'}, {'measure': 'Significantly different metabolites at 16-18 gestational weeks', 'timeFrame': 'Gestatioanl weeks: 16-18 weeks', 'description': 'Metabolomics are used to screen out significant different metabolites. Specific metabolites indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.'}, {'measure': 'Significantly different metabolites at 24-26 gestational weeks', 'timeFrame': 'Gestatioanl weeks: 24-26 weeks', 'description': 'Metabolomics are used to screen out significant different metabolites. Specific metabolites indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.'}, {'measure': 'Significantly different metabolites at 32-34 gestational weeks', 'timeFrame': 'Gestatioanl weeks: 32-34 weeks', 'description': 'Metabolomics are used to screen out significant different metabolites. Specific metabolites indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.'}, {'measure': 'Significantly different proteins at 8-10 gestational weeks', 'timeFrame': 'Gestatioanl weeks: 8-10 weeks', 'description': 'Proteomics are used to screen out significant different proteins. Specific proteins indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.'}, {'measure': 'Significantly different proteins at 16-18 gestational weeks', 'timeFrame': 'Gestatioanl weeks: 16-18 weeks', 'description': 'Proteomics are used to screen out significant different proteins. Specific proteins indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.'}, {'measure': 'Significantly different proteins at 24-26 gestational weeks', 'timeFrame': 'Gestatioanl weeks: 24-26 weeks', 'description': 'Proteomics are used to screen out significant different proteins. Specific proteins indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.'}, {'measure': 'Significantly different proteins at 32-34 gestational weeks', 'timeFrame': 'Gestatioanl weeks: 32-34 weeks', 'description': 'Proteomics are used to screen out significant different proteins. Specific proteins indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestatiaonl Diabetes Mellitus', 'Early Pregnancy']}, 'descriptionModule': {'briefSummary': 'Gestational Diabetes Mellitus (GDM) refers to the abnormal glucose metabolism first detected during pregnancy. It is estimated that approximately 7% of pregnant women worldwide and their offspring are affected by GDM. The incidence of GDM in China is as high as 18.9%. A number of studies have shown that GDM complicates 3%-25% of pregnancies and poses serious health and life threats to the mother and child. In fact, due to the lack of physical activity during pregnancy and the decrease of insulin sensitivity compared with non-pregnancy, the optimal time for intervention has long been lost until the diagnosis of GDM in the second trimester. However, it is a pity that no authoritative screening method for GDM in early pregnancy has been established, and the pathogenesis of GDM is still unclear. This study intend to search for biomarkers used for screening of GDM in early pregnancy and explore the pathogenesis of GDM, so as to provide new ideas for prevention measures and treatment targets of GDM.'}, '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* Maternal age: 20-49 years\n* Plan to have routine prenatal examinations and give birth in the research center\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, hypertension, heart disease, liver and kidney diseases, thyroid diseases, autoimmune diseases, malignant tumors, AIDS, etc.\n* Fetus has a known deformity or genetic defects\n* Incomplete clinical data'}, 'identificationModule': {'nctId': 'NCT05142020', 'briefTitle': 'Biomarkers for Early Screening of Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': "Women's Hospital School Of Medicine Zhejiang University"}, 'officialTitle': 'Study on Early Screening Biomarkers of Gestational Diabetes Mellitus and Its Related Pathogenesis', 'orgStudyIdInfo': {'id': 'Early Screening of GDM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GDM group', 'description': 'Specimen collection and clinical follow-up'}, {'label': 'Control group', 'description': 'Specimen collection and clinical follow-up'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Danqing Chen', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Women's Hospital School Of Medicine Zhejiang University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}