- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07565727
Cardiometabolic Disease and Substrate Metabolism (CAP)
Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study
Обзор исследования
Статус
Условия
- Резистентность к инсулину
- Осложнения беременности
- Беременность
- Преэклампсия
- Сахарный диабет при беременности
- Гестационный сахарный диабет при беременности
- Плацентарная дисфункция
- Гестационный сахарный диабет (ГСД)
- Преэклампсия (ПЭ)
- Кардиометаболические заболевания
- Гестационные осложнения
- Риск преэклампсии (ПЭ)
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Jill M Maples, PhD
- Номер телефона: 865-305-9367
- Электронная почта: jmaples1@utmck.edu
Учебное резервное копирование контактов
- Имя: Hana O El-Messidi, BS
- Номер телефона: 865-305-5592
- Электронная почта: hel1@utmck.edu
Места учебы
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Tennessee
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Knoxville, Tennessee, Соединенные Штаты, 37920
- Рекрутинг
- University of Tennessee Graduate School of Medicine
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Контакт:
- Jill M Maples, PhD
- Номер телефона: 865-305-9367
- Электронная почта: jmaples1@utmck.edu
-
Контакт:
- Hana O El-Messidi, BS
- Номер телефона: 865-305-5592
- Электронная почта: hel1@utmck.edu
-
Главный следователь:
- Jacklyn Locklear, MD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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Pregnant individuals at risk for cardiometabolic disease
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Early Pregnancy Fasting Insulin (mIU/mL)
Временное ограничение: 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
Временное ограничение: 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
|
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Early Pregnancy Fasting Lipid Oxidation Rate (g/min)
Временное ограничение: 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)
Временное ограничение: 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
|
|
Late Pregnancy Homeostatic Model Assessment for Insulin Resistance
Временное ограничение: 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)
Временное ограничение: 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
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Early Pregnancy Fasting Resting Metabolic Rate (kcal/day)
Временное ограничение: 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
|
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Early Pregnancy Fasting Resting Respiratory Quotient
Временное ограничение: 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)
Временное ограничение: 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
|
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Early Pregnancy Fasting Glucose (mg/dL)
Временное ограничение: 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
|
Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
|
|
Early Pregnancy Fasting Lactate (mmol/L)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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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)
Временное ограничение: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting lactate level (mmol/L) 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 Fasting Triglycerides (mg/dL)
Временное ограничение: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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Late pregnancy fasting triglycerides level (mg/dL) 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 Fasting High Density Lipoprotein (mg/dL)
Временное ограничение: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age
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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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
|
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Late Pregnancy Fasting Free Fatty Acids (mEq/L)
Временное ограничение: 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
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Заболевания эндокринной системы
- Женские мочеполовые заболевания и осложнения беременности
- Метаболические заболевания
- Нарушения метаболизма глюкозы
- Сахарный диабет
- Гипертония, вызванная беременностью
- Гиперинсулинизм
- Пищевые и метаболические заболевания
- Диабет, гестационный
- Преэклампсия
- Осложнения беременности
- Резистентность к инсулину
Другие идентификационные номера исследования
- 5483
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Сроки обмена IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
Информация о лекарствах и устройствах, исследовательские документы
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Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .