[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636441":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":11,"locations":21,"responsibleParty":41,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":57,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":73,"overallStatus":23,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of Tennessee Graduate School of Medicine","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":10},"Pregnant individuals at risk for cardiometabolic disease",null,[12,17],{"name":13,"role":14,"phone":15,"phoneExt":10,"email":16},"Jill M Maples, PhD","CONTACT","865-305-9367","jmaples1@utmck.edu",{"name":18,"role":14,"phone":19,"phoneExt":10,"email":20},"Hana O El-Messidi, BS","865-305-5592","hel1@utmck.edu",[22],{"facility":5,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"RECRUITING","Knoxville","Tennessee","37920","United States","US",{"type":30,"coordinates":31},"Point",[32,33],-83.92074,35.96064,{"lat":33,"lon":32},[36,37,38],{"name":13,"role":14,"phone":15,"phoneExt":10,"email":16},{"name":18,"role":14,"phone":19,"phoneExt":10,"email":20},{"name":39,"role":40,"phone":10,"phoneExt":10,"email":10},"Jacklyn Locklear, MD","PRINCIPAL_INVESTIGATOR",{"type":42,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100636441","cardiometabolic-disease-and-substrate-metabolism-100636441",false,"NCT07565727","Cardiometabolic Disease and Substrate Metabolism","Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study","CAP","Inclusion Criteria:\n\n* Age 18-45\n* Any pre-pregnancy BMI\n* At least one high risk OR one moderate risk factor for pre-eclampsia based on ACOG and USPSTF guidelines\n* Willingness to adhere to aspirin therapy\n* Willingness to undergo 2h OGTT for serum collection in addition to survey collection, indirect calorimetry, body composition measures, neonatal measures, etc.\n* Gestational age at enrollment \\\u003C18 weeks\n* Ability to speak, read, and communicate via English\n\nExclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n* Type 1 Diabetes Mellitus\n* Current gestational diabetes mellitus\n* Current\u002Factive platelet disorder or bleeding diathesis (thrombocytopenia of any etiology, idiopathic thrombocytopenic purpura\u002FITP, thrombotic thrombocytopenic purpura\u002FTTP, von Willebrand disease, etc.)\n* Thrombophilia\n* Current use of NSAID for other indication (indomethacin, ibuprofen, etc.)\n* Current use of other immune-modulating agents and biologics (hydroxychloroquine, azathioprine, 6-mercaptopurine, IL-6 inhibitors, etc.)\n* Current or recent use of steroids\n* Current use of prophylactic or therapeutic anticoagulation\n* Medical contraindication to aspirin therapy\n* Molar pregnancy\n* Renal disease\n* Inability or unwillingness to give informed consent\n* Current psychiatric illness\u002Fsocial situation that would limit compliance with study requirements, as determined by the principal investigators","FEMALE","18 Years","45 Years",{"count":55,"type":56},50,"ESTIMATED","9 Months","OBSERVATIONAL","This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.",[61,62,63,64,65,66,67,68,69,70,71,72],"Preeclampsia","Gestational Diabetes Mellitus (GDM)","Preeclampsia (PE)","Preeclampsia (PE) Risk","Gestational Diabetes","Gestational Diabetes Mellitus in Pregnancy","Cardiometabolic Diseases","Insulin Resistance","Placental Dysfunction","Pregnancy","Pregnancy Complications","Gestational Complications",[74,75,61,65,76,77,78,79,80],"Cardiometabolic disease","Substrate metabolism","Insulin resistance","HOMA-IR","Lipid oxidation","Placental dysfunction","Chorangiosis","2026-04-27",{"date":83,"type":84},"2026-05-04","ACTUAL",{"date":86,"type":84},"2025-12-10",{"date":88,"type":56},"2027-08",{"name":5,"class":6},1]