[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07565727":3,"trial-entities:NCT07565727":196,"trial-summary:NCT07565727":199},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":31,"study_type":39,"primary_purpose":40,"phases":41,"enrollment_info":42,"interventions":45,"primary_outcomes":46,"secondary_outcomes":71,"sex":138,"minimum_age":139,"maximum_age":140,"healthy_volunteers":15,"eligibility_criteria":141,"std_ages":166,"locations":168,"central_contacts":190,"overall_officials":193,"references":194,"see_also_links":195},"NCT07565727","5483","Cardiometabolic Disease and Substrate Metabolism","Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study","RECRUITING","2027-08","2026-01","2026-05-04","2025-12-10","University of Tennessee Graduate School of Medicine","OTHER",false,"This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.","Cardiometabolic disease such as pre-eclampsia (PreE) and gestational diabetes (GDM) affect close to 15% of pregnancies and are a major cause of maternal and neonatal morbidity and mortality. Much of the clinical data surrounding these disorders focuses on management during pregnancy and counseling regarding risks of continued cardiometabolic dysfunction after pregnancy. Data are much more limited regarding assessing and managing cardiometabolic dysfunction leading into or early in pregnancy. Furthermore, there are even less data describing metabolic dysfunction outside of GDM and PreE as relate to future cardiometabolic risk.\n\nThe standard of care of assessing metabolic dysfunction during pregnancy, specifically gestational diabetes, is a two-step glucose challenge approach. Outside of pregnant populations, metabolic dysfunction is assessed from a more holistic approach including assessment of insulin, lactate, triglycerides, HDL, LDL, VDRL, cholesterol and free fatty acids.\n\nData are currently lacking on substrate metabolism other than glucose in pregnancy. There are some data that describe maternal lipid metabolism in pregnancy, but most of these data focus on lipid metabolism as it relates to fetal growth and fat mass, but none describe substrate metabolism as it relates to development of maternal disease such as insulin resistance.\n\nAdditionally, the placenta is an extremely metabolically active organ that responds to changes in maternal stress. There is evidence in animal studies that the placenta can alter transportation of carbohydrates, lipids and amnio acids in response to changes in heat, undernutrition, hypoglycemia and glucocorticoid administration.\n\nTraditional hypotheses regarding development of cardiometabolic disease in pregnancy surrounded topics such as abnormal placentation, dysfunctional spiral arteries and hormones such as human placental lactogen. Outside of pregnancy, studies have shown that endothelial dysfunction has been linked to cardiometabolic disease due to its role in regulating vascular tone and glycolysis. Furthermore, there is evidence to support that gestational diabetes is a risk factor for development of endothelial dysfunction; however, in vivo endothelial dysfunction in GDM is not well explored. While there are data that describe endothelial dysfunction in pregnancy as it relates to pre-eclampsia, most studies describe indirect measures of endothelial dysfunction using proteins such as VEGF, PLGF, and SFLT1.\n\nThe metabolic profiles in pregnant people at risk for cardiometabolic disease has not been explored heavily. By assessing both maternal substrate metabolism as well as placental function and pathology, we hope to better understand disease from the lens of not just the maternal but also the fetal and placental unit. Therefore, this study seeks to evaluate the relationship between substrate metabolism of pregnant individuals as it relates to their development of cardiometabolic disease in pregnancy with hopes for more translational research to design better targeted therapies.",[19,20,21,22,23,24,25,26,27,28,29,30],"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",[32,33,19,23,34,35,36,37,38],"Cardiometabolic disease","Substrate metabolism","Insulin resistance","HOMA-IR","Lipid oxidation","Placental dysfunction","Chorangiosis","OBSERVATIONAL",null,[],{"count":43,"type":44},50,"ESTIMATED",[],[47,51,55,59,63,67],{"measure":48,"description":49,"timeFrame":50},"Early Pregnancy Fasting Insulin (mIU\u002FmL)","Early pregnancy fasting insulin level (mIU\u002FmL) in venous blood","Fasting, at the beginning of a single study visit between 12-18 weeks gestational age",{"measure":52,"description":53,"timeFrame":54},"Early Pregnancy Homeostatic Model Assessment for Insulin Resistance","Approximates early pregnancy insulin resistance.","Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 12-18 weeks gestational age",{"measure":56,"description":57,"timeFrame":58},"Early Pregnancy Fasting Lipid Oxidation Rate (g\u002Fmin)","Early pregnancy fasting lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry","Measured at the start of a single study visit between 12-18 weeks gestational age",{"measure":60,"description":61,"timeFrame":62},"Late Pregnancy Fasting Insulin (mIU\u002FmL)","Late pregnancy fasting insulin level (mIU\u002FmL) in venous blood","Fasting, at the beginning of a single study visit between 26-30 weeks gestational age",{"measure":64,"description":65,"timeFrame":66},"Late Pregnancy Homeostatic Model Assessment for Insulin Resistance","Approximates late pregnancy insulin resistance.","Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 26-30 weeks gestational age",{"measure":68,"description":69,"timeFrame":70},"Late Pregnancy Fasting Lipid Oxidation Rate (g\u002Fmin)","Fasting late pregnancy lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry","Measured at the start of a single study visit between 26-30 weeks gestational age",[72,75,78,81,84,87,90,93,96,99,102,105,108,111,114,117,120,123,126,129,132,135],{"measure":73,"description":74,"timeFrame":58},"Early Pregnancy Fasting Resting Metabolic Rate (kcal\u002Fday)","Early pregnancy resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry",{"measure":76,"description":77,"timeFrame":58},"Early Pregnancy Fasting Resting Respiratory Quotient","Early pregnancy resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry",{"measure":79,"description":80,"timeFrame":58},"Early Pregnancy Fasting Carbohydrate Oxidation Rate (g\u002Fmin)","Early pregnancy fasting carbohydrate oxidation rate measures whole body carbohydrate oxidation, which is assessed using indirect calorimetry",{"measure":82,"description":83,"timeFrame":50},"Early Pregnancy Fasting Glucose (mg\u002FdL)","Early pregnancy fasting glucose level (mg\u002FdL) in venous blood",{"measure":85,"description":86,"timeFrame":50},"Early Pregnancy Fasting Lactate (mmol\u002FL)","Early pregnancy fasting lactate level (mmol\u002FL) in venous blood",{"measure":88,"description":89,"timeFrame":50},"Early Pregnancy Fasting Triglycerides (mg\u002FdL)","Early pregnancy fasting triglycerides level (mg\u002FdL) in venous blood",{"measure":91,"description":92,"timeFrame":50},"Early Pregnancy Fasting High Density Lipoprotein (mg\u002FdL)","Early pregnancy fasting high density lipoprotein level (HDL) (mg\u002FdL) in venous blood",{"measure":94,"description":95,"timeFrame":50},"Early Pregnancy Fasting Very Low Density Lipoprotein (mg\u002FdL)","Early pregnancy fasting very low density lipoprotein level (VLDL) (mg\u002FdL) in venous blood",{"measure":97,"description":98,"timeFrame":50},"Early Pregnancy Fasting Low Density Lipoprotein (mg\u002FdL)","Early pregnancy fasting low density lipoprotein level (LDL) (mg\u002FdL) in venous blood",{"measure":100,"description":101,"timeFrame":50},"Early Pregnancy Fasting Cholesterol (mg\u002FdL)","Early pregnancy fasting cholesterol level (mg\u002FdL) in venous blood",{"measure":103,"description":104,"timeFrame":50},"Early Pregnancy Fasting Free Fatty Acids (mEq\u002FL)","Early pregnancy fasting free fatty acids (FFA) (mEq\u002FL) in venous blood",{"measure":106,"description":107,"timeFrame":70},"Late Pregnancy Fasting Resting Metabolic Rate (kcal\u002Fday)","Late pregnancy resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry",{"measure":109,"description":110,"timeFrame":70},"Late Pregnancy Fasting Resting Respiratory Quotient","Late pregnancy resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry",{"measure":112,"description":113,"timeFrame":70},"Late Pregnancy Fasting Carbohydrate Oxidation Rate (g\u002Fmin)","Late pregnancy fasting carbohydrate oxidation rate measures whole body carbohydrate oxidation, which is assessed using indirect calorimetry",{"measure":115,"description":116,"timeFrame":62},"Late Pregnancy Fasting Glucose (mg\u002FdL)","Late pregnancy fasting glucose level (mg\u002FdL) in venous blood",{"measure":118,"description":119,"timeFrame":62},"Late Pregnancy Fasting Lactate (mmol\u002FL)","Late pregnancy fasting lactate level (mmol\u002FL) in venous blood",{"measure":121,"description":122,"timeFrame":62},"Late Pregnancy Fasting Triglycerides (mg\u002FdL)","Late pregnancy fasting triglycerides level (mg\u002FdL) in venous blood",{"measure":124,"description":125,"timeFrame":62},"Late Pregnancy Fasting High Density Lipoprotein (mg\u002FdL)","Late pregnancy fasting high density lipoprotein level (HDL) (mg\u002FdL) in venous blood",{"measure":127,"description":128,"timeFrame":62},"Late Pregnancy Fasting Very Low Density Lipoprotein (mg\u002FdL)","Late pregnancy fasting very low density lipoprotein level (VLDL) (mg\u002FdL) in venous blood",{"measure":130,"description":131,"timeFrame":62},"Late Pregnancy Fasting Low Density Lipoprotein (mg\u002FdL)","Late pregnancy fasting low density lipoprotein level (LDL) (mg\u002FdL) in venous blood",{"measure":133,"description":134,"timeFrame":62},"Late Pregnancy Fasting Cholesterol (mg\u002FdL)","Late pregnancy fasting cholesterol level (mg\u002FdL) in venous blood",{"measure":136,"description":137,"timeFrame":62},"Late Pregnancy Fasting Free Fatty Acids (mEq\u002FL)","Late pregnancy fasting free fatty acids (FFA) (mEq\u002FL) in venous blood","FEMALE","18 Years","45 Years",{"inclusion":142,"exclusion":150,"raw_text":165},[143,144,145,146,147,148,149],"Age 18-45","Any pre-pregnancy BMI","At least one high risk OR one moderate risk factor for pre-eclampsia based on ACOG and USPSTF guidelines","Willingness to adhere to aspirin therapy","Willingness to undergo 2h OGTT for serum collection in addition to survey collection, indirect calorimetry, body composition measures, neonatal measures, etc.","Gestational age at enrollment \\\u003C18 weeks","Ability to speak, read, and communicate via English",[151,152,153,154,155,156,157,158,159,160,161,162,163,164],"Type 2 Diabetes Mellitus","Type 1 Diabetes Mellitus","Current gestational diabetes mellitus","Current\u002Factive platelet disorder or bleeding diathesis (thrombocytopenia of any etiology, idiopathic thrombocytopenic purpura\u002FITP, thrombotic thrombocytopenic purpura\u002FTTP, von Willebrand disease, etc.)","Thrombophilia","Current use of NSAID for other indication (indomethacin, ibuprofen, etc.)","Current use of other immune-modulating agents and biologics (hydroxychloroquine, azathioprine, 6-mercaptopurine, IL-6 inhibitors, etc.)","Current or recent use of steroids","Current use of prophylactic or therapeutic anticoagulation","Medical contraindication to aspirin therapy","Molar pregnancy","Renal disease","Inability or unwillingness to give informed consent","Current psychiatric illness\u002Fsocial situation that would limit compliance with study requirements, as determined by the principal investigators","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",[167],"ADULT",[169],{"facility":13,"status":8,"city":170,"state":171,"zip":172,"country":173,"contacts":174,"geoPoint":187},"Knoxville","Tennessee","37920","United States",[175,180,184],{"name":176,"role":177,"phone":178,"email":179},"Jill M Maples, PhD","CONTACT","865-305-9367","jmaples1@utmck.edu",{"name":181,"role":177,"phone":182,"email":183},"Hana O El-Messidi, BS","865-305-5592","hel1@utmck.edu",{"name":185,"role":186},"Jacklyn Locklear, MD","PRINCIPAL_INVESTIGATOR",{"lat":188,"lon":189},35.96064,-83.92074,[191,192],{"name":176,"role":177,"phone":178,"email":179},{"name":181,"role":177,"phone":182,"email":183},[],[],[],{"nct_id":4,"conditions":197,"biomarkers":198},[23,26,19,28],[],{"nct_id":4,"found":200,"summary":201,"prompt_version":211},true,{"design":202,"status":203,"heading":204,"summary":205,"follow_up":206,"word_count":207,"commitments":208,"compensation":209,"drugs_mentioned":210},"This is an observational study, meaning researchers will observe participants without providing specific interventions. It plans to include 50 women.","completed","Cardiometabolic Disease and Substrate Metabolism Study","This observational study is looking at the connection between cardiometabolic diseases, like preeclampsia (high blood pressure during pregnancy) and gestational diabetes (diabetes that develops during pregnancy), and how your body uses fats for energy (maternal lipid oxidation). Researchers want to understand if insulin resistance (when your body doesn't respond well to insulin) is related to how your body processes fats early in pregnancy. You might be able to join if you are a woman between 18 and 45 years old, have certain risk factors for preeclampsia, and are willing to take aspirin and undergo specific tests. The study aims to measure your fasting insulin, insulin resistance, and how quickly your body uses fats for energy early in your pregnancy. The current status of this study is unclear, and it plans to enroll 50 participants.","The primary endpoints are measured at the beginning of a single study visit between 12-18 weeks gestational age. No further follow-up is specified.",134,"You would need to agree to take aspirin and undergo a 2-hour oral glucose tolerance test (OGTT) for blood collection, surveys, indirect calorimetry (to measure metabolism), and body composition measures. These measurements would occur during a single study visit between 12-18 weeks of gestational age.","Not stated in the trial record.",[],"v2"]