Clinical trial NCT06802861: Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia
Official title: Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preeclampsia
Preeclampsia (PE)
Preeclampsia (PE) Risk
Obesity and Obesity-related Medical Conditions
Pregnancy
Pregnancy Complications
Gestational Diabetes
Gestational Diabetes Mellitus in Pregnancy
Gestational Complications
Keywords: metabolic dysfunction
gestational diabetes
pregnancy
maternal obesity
maternal insulin resistance
aspirin metabolism
GDM
substrate oxidation
gestational glucose intolerance
Lead sponsor: University of Tennessee Graduate School of Medicine
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant individuals at risk for preeclampsia

Brief summary: This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia. Further, we will add an exploratory outcome to evaluate the neonatal body composition and anthropometric data to better understand neonatal impacts of maternal metabolic dysfunction.


Eligibility criteria: Inclusion Criteria:

* Recommended aspirin for pre-eclampsia prevention by OB/GYN or MFM specialist based on ACOG and USPSTF guidelines (1 high risk factor, 2+ moderate risk factors)

  * Willingness to adhere to aspirin therapy
  * Willingness to undergo 2h OGTT for serum and urine collection in addition to survey collection, indirect calorimetry, body composition measures, neonatal measures, etc.
  * Gestational age at enrollment \<16 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

Primary outcomes:
measure: Untargeted metabolomic profile
timeFrame: 60 minutes after ingestion of 75 grams of glucose
Secondary outcomes:
measure: Urinary thromboxane B2 level
timeFrame: 60 minutes after ingestion of 75 grams of glucose, during a single study visit
measure: Fasting Salicylate level
timeFrame: Fasting, at the beginning of a single study visit
measure: 1 Hour Salicylate level
timeFrame: 60 minutes after ingestion of 75 grams of glucose during a single study visit
measure: 2 Hour Salicylate level
timeFrame: 120 minutes after ingestion of 75 grams of glucose during a single study visit
measure: Fasting PFA-100 epinephrine closure time
timeFrame: Fasting, at the beginning of a single study visit
measure: 1 Hour PFA-100 epinephrine closure time
timeFrame: 60 minutes after ingestion of 75 grams of glucose during a single study visit
measure: 2 Hour PFA-100 epinephrine closure time
timeFrame: 120 minutes after ingestion of 75 grams of glucose during a single study visit
measure: Homeostatic Model Assessment for Insulin Resistance
timeFrame: Calculated from fasting insulin and fasting glucose collected at the start of a single study visit
measure: Fasting Resting Metabolic Rate
timeFrame: Measured at the start of a single study visit
measure: Fasting Respiratory Quotient
timeFrame: Measured at the start of a single study visit
measure: Fasting Carbohydrate Oxidation Rate
timeFrame: Measured at the start of a single study visit
measure: Fasting Lipid Oxidation Rate
timeFrame: Measured at the start of a single study visit
measure: Fasting Insulin
timeFrame: Fasting, at the beginning of a single study visit
measure: Fasting glucose
timeFrame: Fasting, at the beginning of a single study visit
measure: Fasting lactate
timeFrame: Fasting, at the beginning of a single study visit
measure: Fasting triglycerides
timeFrame: Fasting, at the beginning of a single study visit
measure: Fasting high density lipoprotein
timeFrame: Fasting, at the beginning of a single study visit
measure: Fasting very low density lipoprotein
timeFrame: Fasting, at the beginning of a single study visit
measure: Fasting low density lipoprotein
timeFrame: Fasting, at the beginning of a single study visit
measure: Fasting cholesterol
timeFrame: Fasting, at the beginning of a single study visit
measure: Fasting free fatty acids
timeFrame: Fasting, at the beginning of a single study visit
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
Study officials:
References: