[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100280104":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":13,"centralContacts":10,"locations":17,"responsibleParty":30,"collaborators":33,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":10,"overallStatus":55,"whyStopped":10,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},{"fullName":5,"class":6},"Pennington Biomedical Research Center","OTHER",[8,11],{"label":9,"type":10,"description":10,"interventionNames":10},"Pregnant women diagnosed with gestational diabetes",null,{"label":12,"type":10,"description":10,"interventionNames":10},"Pregnant women with normal pregnancy",[14],{"name":15,"affiliation":5,"role":16},"Leanne M Redman, PhD","PRINCIPAL_INVESTIGATOR",[18],{"facility":5,"status":10,"city":19,"state":20,"zip":21,"country":22,"countryCode":23,"cosmosGeoPoint":24,"geoPoint":29,"contacts":10},"Baton Rouge","Louisiana","70808","United States","US",{"type":25,"coordinates":26},"Point",[27,28],-91.18747,30.44332,{"lat":28,"lon":27},{"type":16,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Leanne Redman","Associate Professor",[34],{"name":35,"class":6},"University of Colorado, Denver","100280104","investigation-of-mechanisms-for-transmission-of-impaired-glucose-metabolism-in-infants-exposed-to-diabetes-in-utero-100280104",false,"NCT02926079","Investigation of Mechanisms for Transmission of Impaired Glucose Metabolism in Infants Exposed to Diabetes in Utero","IMAGINE","Inclusion Criteria (Mother):\n\n* BMI between 20 kg\u002Fm2 and 40 kg\u002Fm2 prior to the current pregnancy (determined by self-report and confirmation of pregravid BMI of the index pregnancy from the prenatal record)\n* Completion of standardized glucose tolerance testing (between 24-28 weeks gestation) in the index pregnancy; either a single 2 hour, 75g glucose tolerance test or the two-step: 1 hour 50g and 3 hour 100g glucose tolerance test to confirm diagnosis of gestational diabetes mellitus or normal glucose tolerance\n* Medically cleared for participation in the study by primary care obstetrician or midwife\n* Medically cleared for participation by the Medical Investigator\n* Medical record release (prenatal record, hospital delivery record) for study staff to access information in the medical record related to the current and if applicable, the prior pregnancy.\n* Willingness to enroll the infant in the study provided inclusion\u002Fexclusion criteria pertaining to the infant are met\n\nInclusion criteria (Infant):\n\n* Born full-term (\\>37,0 weeks gestation)\n* Available for clinical assessments between 10-30 days old\n* Healthy\n\nExclusion Criteria (Mother):\n\n* Use of insulin therapy in the index pregnancy\n* History of preterm birth\n* History of intrauterine growth-restriction\n* Evidence of gestational hypertension (SBP \\>160 mmHg \\& DBP \\>110 mmHg)\n* HIV or AIDS (self-reported)\n* Planned termination of pregnancy or adoption or unwillingness to enroll the infant in the study\n\nExclusion Criteria (Infant):\n\n* Using medications to treat a chronic condition (does not include use of vitamin supplements or PRN medication for flatulence)\n* Unwilling or unable to be fed 2 fl oz of infant formula\n* Diagnosed with a congenital abnormality or disability that would render testing unsafe or would interfere with data collection",true,"FEMALE","18 Years","40 Years",{"count":48,"type":49},18,"ACTUAL","OBSERVATIONAL","This proposed study; Investigation of mechanisms for transmission of impaired glucose metabolism in infants exposed to diabetes in utero, will test the overarching hypothesis that impaired maternal substrate oxidation (metabolic inflexibility) and placental lipotoxicity are characteristics of diabetic pregnancies and in utero development within these conditions programs a metabolically inflexible phenotype in the offspring.",[53,54],"Pregnancy","Gestational Diabetes Mellitus","COMPLETED","2022-09-26",{"date":58,"type":49},"2022-09-27",{"date":60,"type":49},"2017-05-23",{"date":62,"type":49},"2019-01-08",{"name":5,"class":6},1]