Cardiometabolic Disease and Substrate Metabolism (CAP)
Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Jill M Maples, PhD
- 電話番号:865-305-9367
- メール:jmaples1@utmck.edu
研究連絡先のバックアップ
- 名前:Hana O El-Messidi, BS
- 電話番号:865-305-5592
- メール:hel1@utmck.edu
研究場所
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Tennessee
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Knoxville、Tennessee、アメリカ、37920
- 募集
- University of Tennessee Graduate School of Medicine
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コンタクト:
- Jill M Maples, PhD
- 電話番号:865-305-9367
- メール:jmaples1@utmck.edu
-
コンタクト:
- Hana O El-Messidi, BS
- 電話番号:865-305-5592
- メール:hel1@utmck.edu
-
主任研究者:
- Jacklyn Locklear, MD
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Pregnant individuals at risk for cardiometabolic disease
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Early Pregnancy Fasting Insulin (mIU/mL)
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
|
|
Late Pregnancy Fasting Lipid Oxidation Rate (g/min)
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Early Pregnancy Fasting Resting Metabolic Rate (kcal/day)
時間枠: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
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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 Resting Respiratory Quotient
時間枠: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
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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)
時間枠: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)
時間枠: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
|
|
Early Pregnancy Fasting Lactate (mmol/L)
時間枠: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
|
|
Early Pregnancy Fasting Triglycerides (mg/dL)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
|
|
Late Pregnancy Fasting Resting Metabolic Rate (kcal/day)
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 5483
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IPD 共有サポート情報タイプ
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