Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-02 @ 8:32 AM
Study NCT ID:
NCT03415295
Status:
COMPLETED
Last Update Posted:
2018-01-31
First Post:
2018-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Trimethylamine-N-oxide and Gestational Diabetes Mellitus
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Maternal fasting blood samples were collected in anticoagulative tubes and centrifuged at 3000 rpm for 5 min. Then, the plasma was separated and stored at -80°C for subsequent analysis of TMAO and other blood parameters.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1694}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2018-01-23', 'lastUpdatePostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gestational diabetes mellitus', 'timeFrame': 'During 24-32 weeks of gestation', 'description': 'Glucose intolerance with onset or first diagnosis during pregnancy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trimethylamine-N-oxide; Gestational diabetes mellitus'], 'conditions': ['Gestational Diabetes']}, 'referencesModule': {'references': [{'pmid': '30535087', 'type': 'DERIVED', 'citation': 'Li P, Zhong C, Li S, Sun T, Huang H, Chen X, Zhu Y, Hu X, Peng X, Zhang X, Bao W, Shan Z, Cheng J, Hu FB, Yang N, Liu L. Plasma concentration of trimethylamine-N-oxide and risk of gestational diabetes mellitus. Am J Clin Nutr. 2018 Sep 1;108(3):603-610. doi: 10.1093/ajcn/nqy116.'}]}, 'descriptionModule': {'briefSummary': "Background: The microbiota-dependent metabolite trimethylamine-N-oxide (TMAO) has been reported as a novel and independent risk factor for the development of cardiovascular and metabolic diseases, but the association with gestational diabetes mellitus (GDM) remains unclear.\n\nObjective: To investigate the association between plasma TMAO concentration and GDM in a two-phase study.\n\nDesign: The initial discovery phase included 866 pregnant women (433 GDM cases and 433 matched controls) in Wuhan China. Study participants were recruited from pregnant women who attended the outpatient clinics of the Department of Endocrinology, Tongji Hospital, to screen for GDM between August 2012 and April 2015, or pregnant women who visited the Hubei Maternal and Child Health Hospital or the Central Hospital of Wuhan for a routine antenatal checkup from May 2014 to November 2016. The inclusion criteria of participants were: age ≥ 20 years, gestational age between 24 and 32 weeks, no history of a diagnosis of diabetes or gestational diabetes, and no history of receiving pharmacological treatment known to affect glucose metabolism. An independent replication phase study was nested within an ongoing prospective cohort study, namely the Tongji Maternal and Child Health Cohort (TMCHC). Beginning in January 2013, women receiving prenatal care prior to 16 weeks of gestation were invited to join the TMCHC. Exclusion criteria included pre-pregnancy diabetes, clinically significant neurological, endocrinological or other systemic diseases and multiple pregnancies. All enrolled pregnant women received a regular prenatal checkup in hospital and underwent an oral glucose tolerance test (OGTT) during 24-32 weeks of gestation to screen for GDM. 276 members who developed GDM before May 2016 and had fasting blood collected before 20 weeks'gestation were included as cases in this analysis. Two controls were individually matched to each case from among women without GDM. These two studies were approved by the ethics committee of Tongji Medical College. All the participants gave informed written consent before they were included in the study. Plasma TMAO concentrations were determined by stable isotope dilution liquid chromatography with online electrospray ionization tandem mass spectrometry."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All the participants enrolled were Chinese women. They gave informed written consent to the study and did not take any medication known to affect glucose tolerance or insulin secretion before participation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 20 years;\n* Screened for GDM during 24-32 weeks of gestation;\n* With fasting blood samples collected before 20 weeks of gestation (only for nested case-control subjects).\n\nExclusion Criteria:\n\n* History of a diagnosis of diabetes or gestational diabetes;\n* History of receiving pharmacological treatment known to affect glucose metabolism;\n* Clinically significant neurological, endocrinological or other systemic diseases and multiple pregnancies.'}, 'identificationModule': {'nctId': 'NCT03415295', 'briefTitle': 'Association Between Trimethylamine-N-oxide and Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Association Between Trimethylamine-N-oxide Levels and Risk of Gestational Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'SZSM201511007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gestational diabetes mellitus', 'description': 'Gestational diabetes mellitus (GDM) was diagnosed according to the American Diabetes Association criteria, which is based on the "one-step" approach recommended by the International Association of Diabetes and Pregnancy Study Groups. All women underwent a 75g OGTT in the morning after an overnight fast, with plasma glucose measurement fasting and at 1 and 2 hours. The criteria for GDM diagnosis was to have at least one abnormal value: Fasting glucose ≥ 5.1 mmol/L (92 mg/dL), 1 h glucose ≥ 10.0 mmol/L (180 mg/dL), 2 h glucose ≥ 8.5 mmol/L (153 mg/dL).', 'interventionNames': ['Other: Plasma TMAO concentration']}, {'label': 'Healthy pregnant control', 'description': 'Pregnant women with fasting glucose \\< 5.1 mmol/L (92 mg/dL), 1 h glucose \\< 10.0 mmol/L (180 mg/dL) and 2 h glucose \\< 8.5 mmol/L (153 mg/dL) were considered as healthy controls.', 'interventionNames': ['Other: Plasma TMAO concentration']}], 'interventions': [{'name': 'Plasma TMAO concentration', 'type': 'OTHER', 'description': 'Plasma TMAO concentrations were determined by stable isotope dilution liquid chromatography with online electrospray ionization tandem mass spectrometry on an AB SCIEX 4500 triple quadrupole mass spectrometer', 'armGroupLabels': ['Gestational diabetes mellitus', 'Healthy pregnant control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Liegang Liu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Liegang Liu', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}