- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07565727
Cardiometabolic Disease and Substrate Metabolism (CAP)
Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Jill M Maples, PhD
- Telefonní číslo: 865-305-9367
- E-mail: jmaples1@utmck.edu
Studijní záloha kontaktů
- Jméno: Hana O El-Messidi, BS
- Telefonní číslo: 865-305-5592
- E-mail: hel1@utmck.edu
Studijní místa
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Tennessee
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Knoxville, Tennessee, Spojené státy, 37920
- Nábor
- University of Tennessee Graduate School of Medicine
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Kontakt:
- Jill M Maples, PhD
- Telefonní číslo: 865-305-9367
- E-mail: jmaples1@utmck.edu
-
Kontakt:
- Hana O El-Messidi, BS
- Telefonní číslo: 865-305-5592
- E-mail: hel1@utmck.edu
-
Vrchní vyšetřovatel:
- Jacklyn Locklear, MD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
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Pregnant individuals at risk for cardiometabolic disease
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Early Pregnancy Fasting Insulin (mIU/mL)
Časové okno: 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
|
|
Early Pregnancy Homeostatic Model Assessment for Insulin Resistance
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Early Pregnancy Fasting Resting Metabolic Rate (kcal/day)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění endokrinního systému
- Ženské urogenitální onemocnění a těhotenské komplikace
- Metabolické choroby
- Poruchy metabolismu glukózy
- Diabetes Mellitus
- Hypertenze vyvolaná těhotenstvím
- Hyperinzulinismus
- Nutriční a metabolické nemoci
- Diabetes, gestační
- Preeklampsie
- Těhotenské komplikace
- Rezistence na inzulín
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Typ podpůrných informací pro sdílení IPD
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