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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.

Aperçu de l'étude

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

Observationnel

Inscription (Estimé)

50

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

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:
        • 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

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Pregnant individuals at risk for preeclampsia

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 décembre 2025

Achèvement primaire (Estimé)

1 août 2026

Achèvement de l'étude (Estimé)

1 août 2027

Dates d'inscription aux études

Première soumission

27 avril 2026

Première soumission répondant aux critères de contrôle qualité

27 avril 2026

Première publication (Réel)

4 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 avril 2026

Dernière vérification

1 janvier 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

We anticipate publishing the study protocol within the next 2 years

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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