- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07565727
Cardiometabolic Disease and Substrate Metabolism (CAP)
Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study
Studie Overzicht
Toestand
Conditie
- Insuline-resistentie
- Zwangerschap Complicaties
- Zwangerschap
- Pre-eclampsie
- Zwangerschapsdiabetes
- Zwangerschapsdiabetes mellitus tijdens de zwangerschap
- Placenta disfunctie
- Zwangerschapsdiabetes mellitus (GDM)
- Pre-eclampsie (PE)
- Cardiometabolische ziekten
- Zwangerschapscomplicaties
- Pre-eclampsie (PE) Risico
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Jill M Maples, PhD
- Telefoonnummer: 865-305-9367
- E-mail: jmaples1@utmck.edu
Studie Contact Back-up
- Naam: Hana O El-Messidi, BS
- Telefoonnummer: 865-305-5592
- E-mail: hel1@utmck.edu
Studie Locaties
-
-
Tennessee
-
Knoxville, Tennessee, Verenigde Staten, 37920
- Werving
- University of Tennessee Graduate School of Medicine
-
Contact:
- Jill M Maples, PhD
- Telefoonnummer: 865-305-9367
- E-mail: jmaples1@utmck.edu
-
Contact:
- Hana O El-Messidi, BS
- Telefoonnummer: 865-305-5592
- E-mail: hel1@utmck.edu
-
Hoofdonderzoeker:
- Jacklyn Locklear, MD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Pregnant individuals at risk for cardiometabolic disease
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Early Pregnancy Fasting Insulin (mIU/mL)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Early Pregnancy Fasting Resting Metabolic Rate (kcal/day)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Endocriene systeemziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Metabole ziekten
- Glucosemetabolismestoornissen
- Suikerziekte
- Hypertensie, door zwangerschap veroorzaakt
- Hyperinsulinisme
- Voedings- en stofwisselingsziekten
- Diabetes, zwangerschap
- Pre-eclampsie
- Zwangerschap Complicaties
- Insuline-resistentie
Andere studie-ID-nummers
- 5483
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .