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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.

Přehled studie

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

Pozorovací

Zápis (Odhadovaný)

50

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Hana O El-Messidi, BS
  • Telefonní číslo: 865-305-5592
  • E-mail: hel1@utmck.edu

Studijní místa

    • Tennessee
      • Knoxville, Tennessee, Spojené státy, 37920
        • Nábor
        • University of Tennessee Graduate School of Medicine
        • Kontakt:
        • Kontakt:
          • Hana O El-Messidi, BS
          • Telefonní číslo: 865-305-5592
          • E-mail: hel1@utmck.edu
        • Vrchní vyšetřovatel:
          • Jacklyn Locklear, MD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Pregnant individuals at risk for preeclampsia

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

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Pregnant individuals at risk for cardiometabolic disease

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
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
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

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

10. prosince 2025

Primární dokončení (Odhadovaný)

1. srpna 2026

Dokončení studie (Odhadovaný)

1. srpna 2027

Termíny zápisu do studia

První předloženo

27. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

27. dubna 2026

První zveřejněno (Aktuální)

4. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. dubna 2026

Naposledy ověřeno

1. ledna 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Časový rámec sdílení IPD

We anticipate publishing the study protocol within the next 2 years

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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