Cardiometabolic Disease and Substrate Metabolism (CAP)
Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study
研究概览
详细说明
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.
The 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.
Data 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.
Additionally, 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.
Traditional 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.
The 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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Jill M Maples, PhD
- 电话号码:865-305-9367
- 邮箱:jmaples1@utmck.edu
研究联系人备份
- 姓名:Hana O El-Messidi, BS
- 电话号码:865-305-5592
- 邮箱:hel1@utmck.edu
学习地点
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Tennessee
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Knoxville、Tennessee、美国、37920
- 招聘中
- University of Tennessee Graduate School of Medicine
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接触:
- Jill M Maples, PhD
- 电话号码:865-305-9367
- 邮箱:jmaples1@utmck.edu
-
接触:
- Hana O El-Messidi, BS
- 电话号码:865-305-5592
- 邮箱:hel1@utmck.edu
-
首席研究员:
- Jacklyn Locklear, MD
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- 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 <18 weeks
- Ability to speak, read, and communicate via English
Exclusion Criteria:
- Type 2 Diabetes Mellitus
- Type 1 Diabetes Mellitus
- Current gestational diabetes mellitus
- Current/active platelet disorder or bleeding diathesis (thrombocytopenia of any etiology, idiopathic thrombocytopenic purpura/ITP, thrombotic thrombocytopenic purpura/TTP, 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/social situation that would limit compliance with study requirements, as determined by the principal investigators
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Pregnant individuals at risk for cardiometabolic disease
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Early Pregnancy Fasting Insulin (mIU/mL)
大体时间:Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting insulin level (mIU/mL) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Homeostatic Model Assessment for Insulin Resistance
大体时间:Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 12-18 weeks gestational age
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Approximates early pregnancy insulin resistance.
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Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Lipid Oxidation Rate (g/min)
大体时间:Measured at the start of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry
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Measured at the start of a single study visit between 12-18 weeks gestational age
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Late Pregnancy Fasting Insulin (mIU/mL)
大体时间:Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting insulin level (mIU/mL) in venous blood
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Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late Pregnancy Homeostatic Model Assessment for Insulin Resistance
大体时间:Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 26-30 weeks gestational age
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Approximates late pregnancy insulin resistance.
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Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 26-30 weeks gestational age
|
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Late Pregnancy Fasting Lipid Oxidation Rate (g/min)
大体时间:Measured at the start of a single study visit between 26-30 weeks gestational age
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Fasting late pregnancy lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry
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Measured at the start of a single study visit between 26-30 weeks gestational age
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Early Pregnancy Fasting Resting Metabolic Rate (kcal/day)
大体时间:Measured at the start of a single study visit between 12-18 weeks gestational age
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Early pregnancy resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry
|
Measured at the start of a single study visit between 12-18 weeks gestational age
|
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Early Pregnancy Fasting Resting Respiratory Quotient
大体时间:Measured at the start of a single study visit between 12-18 weeks gestational age
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Early pregnancy resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry
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Measured at the start of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Carbohydrate Oxidation Rate (g/min)
大体时间:Measured at the start of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting carbohydrate oxidation rate measures whole body carbohydrate oxidation, which is assessed using indirect calorimetry
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Measured at the start of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Glucose (mg/dL)
大体时间:Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting glucose level (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
|
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Early Pregnancy Fasting Lactate (mmol/L)
大体时间:Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting lactate level (mmol/L) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Triglycerides (mg/dL)
大体时间:Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting triglycerides level (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting High Density Lipoprotein (mg/dL)
大体时间:Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting high density lipoprotein level (HDL) (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Very Low Density Lipoprotein (mg/dL)
大体时间:Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting very low density lipoprotein level (VLDL) (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Low Density Lipoprotein (mg/dL)
大体时间:Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting low density lipoprotein level (LDL) (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
|
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Early Pregnancy Fasting Cholesterol (mg/dL)
大体时间:Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting cholesterol level (mg/dL) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early Pregnancy Fasting Free Fatty Acids (mEq/L)
大体时间:Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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Early pregnancy fasting free fatty acids (FFA) (mEq/L) in venous blood
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Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
|
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Late Pregnancy Fasting Resting Metabolic Rate (kcal/day)
大体时间:Measured at the start of a single study visit between 26-30 weeks gestational age
|
Late pregnancy resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry
|
Measured at the start of a single study visit between 26-30 weeks gestational age
|
|
Late Pregnancy Fasting Resting Respiratory Quotient
大体时间:Measured at the start of a single study visit between 26-30 weeks gestational age
|
Late pregnancy resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry
|
Measured at the start of a single study visit between 26-30 weeks gestational age
|
|
Late Pregnancy Fasting Carbohydrate Oxidation Rate (g/min)
大体时间:Measured at the start of a single study visit between 26-30 weeks gestational age
|
Late pregnancy fasting carbohydrate oxidation rate measures whole body carbohydrate oxidation, which is assessed using indirect calorimetry
|
Measured at the start of a single study visit between 26-30 weeks gestational age
|
|
Late Pregnancy Fasting Glucose (mg/dL)
大体时间:Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
Late pregnancy fasting glucose level (mg/dL) in venous blood
|
Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
|
Late Pregnancy Fasting Lactate (mmol/L)
大体时间:Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
Late pregnancy fasting lactate level (mmol/L) in venous blood
|
Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
|
Late Pregnancy Fasting Triglycerides (mg/dL)
大体时间:Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
Late pregnancy fasting triglycerides level (mg/dL) in venous blood
|
Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
|
Late Pregnancy Fasting High Density Lipoprotein (mg/dL)
大体时间:Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
Late pregnancy fasting high density lipoprotein level (HDL) (mg/dL) in venous blood
|
Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
|
Late Pregnancy Fasting Very Low Density Lipoprotein (mg/dL)
大体时间:Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting very low density lipoprotein level (VLDL) (mg/dL) in venous blood
|
Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
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Late Pregnancy Fasting Low Density Lipoprotein (mg/dL)
大体时间:Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
Late pregnancy fasting low density lipoprotein level (LDL) (mg/dL) in venous blood
|
Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
|
Late Pregnancy Fasting Cholesterol (mg/dL)
大体时间:Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting cholesterol level (mg/dL) in venous blood
|
Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
|
Late Pregnancy Fasting Free Fatty Acids (mEq/L)
大体时间:Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting free fatty acids (FFA) (mEq/L) in venous blood
|
Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 5483
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计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享支持信息类型
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