- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07565727
Cardiometabolic Disease and Substrate Metabolism (CAP)
Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study
Aperçu de l'étude
Statut
Les conditions
- Résistance à l'insuline
- Complications de grossesse
- Grossesse
- Prééclampsie
- Diabète gestationnel
- Diabète sucré gestationnel pendant la grossesse
- Dysfonctionnement placentaire
- Diabète sucré gestationnel (DG)
- Prééclampsie (PE)
- Maladies cardiométaboliques
- Complications gestationnelles
- Risque de prééclampsie (PE)
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jill M Maples, PhD
- Numéro de téléphone: 865-305-9367
- E-mail: jmaples1@utmck.edu
Sauvegarde des contacts de l'étude
- Nom: Hana O El-Messidi, BS
- Numéro de téléphone: 865-305-5592
- E-mail: hel1@utmck.edu
Lieux d'étude
-
-
Tennessee
-
Knoxville, Tennessee, États-Unis, 37920
- Recrutement
- University of Tennessee Graduate School of Medicine
-
Contact:
- Jill M Maples, PhD
- Numéro de téléphone: 865-305-9367
- E-mail: jmaples1@utmck.edu
-
Contact:
- Hana O El-Messidi, BS
- Numéro de téléphone: 865-305-5592
- E-mail: hel1@utmck.edu
-
Chercheur principal:
- Jacklyn Locklear, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
Pregnant individuals at risk for cardiometabolic disease
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Early Pregnancy Fasting Insulin (mIU/mL)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Early Pregnancy Fasting Resting Metabolic Rate (kcal/day)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies du système endocrinien
- Maladies urogénitales féminines et complications de la grossesse
- Maladies métaboliques
- Troubles du métabolisme du glucose
- Diabète sucré
- Hypertension induite par la grossesse
- Hyperinsulinisme
- Maladies nutritionnelles et métaboliques
- Diabète gestationnel
- Pré-éclampsie
- Complications de grossesse
- Résistance à l'insuline
Autres numéros d'identification d'étude
- 5483
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Délai de partage IPD
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