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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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

50

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Hana O El-Messidi, BS
  • Telefonnummer: 865-305-5592
  • E-post: hel1@utmck.edu

Studieorter

    • Tennessee
      • Knoxville, Tennessee, Förenta staterna, 37920
        • Rekrytering
        • University of Tennessee Graduate School of Medicine
        • Kontakt:
        • Kontakt:
          • Hana O El-Messidi, BS
          • Telefonnummer: 865-305-5592
          • E-post: hel1@utmck.edu
        • Huvudutredare:
          • Jacklyn Locklear, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Pregnant individuals at risk for preeclampsia

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Pregnant individuals at risk for cardiometabolic disease

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Early Pregnancy Fasting Insulin (mIU/mL)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Early Pregnancy Fasting Resting Metabolic Rate (kcal/day)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

10 december 2025

Primärt slutförande (Beräknad)

1 augusti 2026

Avslutad studie (Beräknad)

1 augusti 2027

Studieregistreringsdatum

Först inskickad

27 april 2026

Först inskickad som uppfyllde QC-kriterierna

27 april 2026

Första postat (Faktisk)

4 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 april 2026

Senast verifierad

1 januari 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

We anticipate publishing the study protocol within the next 2 years

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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