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Cardiometabolic Disease and Substrate Metabolism (CAP)

Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study

This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.

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

观察性的

注册 (估计的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

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

    • Tennessee
      • Knoxville、Tennessee、美国、37920
        • 招聘中
        • University of Tennessee Graduate School of Medicine
        • 接触:
        • 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

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

Pregnant individuals at risk for preeclampsia

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Pregnant individuals at risk for cardiometabolic disease

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
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
Early pregnancy fasting insulin level (mIU/mL) in venous blood
Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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
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
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
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
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
Late pregnancy fasting insulin level (mIU/mL) in venous blood
Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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
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
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
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

次要结果测量

结果测量
措施说明
大体时间
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
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
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
Early 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 12-18 weeks gestational age
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
Early 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 12-18 weeks gestational age
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
Early pregnancy fasting glucose level (mg/dL) in venous blood
Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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
Early pregnancy fasting lactate level (mmol/L) in venous blood
Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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
Early pregnancy fasting triglycerides level (mg/dL) in venous blood
Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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
Early pregnancy fasting high density lipoprotein level (HDL) (mg/dL) in venous blood
Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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
Early pregnancy fasting very low density lipoprotein level (VLDL) (mg/dL) in venous blood
Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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
Early pregnancy fasting low density lipoprotein level (LDL) (mg/dL) in venous blood
Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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
Early pregnancy fasting cholesterol level (mg/dL) in venous blood
Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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
Early pregnancy fasting free fatty acids (FFA) (mEq/L) in venous blood
Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
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
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
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
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
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

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月10日

初级完成 (估计的)

2026年8月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2026年4月27日

首先提交符合 QC 标准的

2026年4月27日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年5月4日

上次提交的符合 QC 标准的更新

2026年4月27日

最后验证

2026年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Reasonable requests will be considered on a case-by-case basis.

IPD 共享时间框架

We anticipate publishing the study protocol within the next 2 years

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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