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NCT Number: NCT06802861

Relationship Between Aspirin Metabolism and Markers of Metabolic Dysfunction Among Pregnant Persons at Risk of Pre-eclampsia

This study's primary purpose is to determine the relationship between aspirin metabolism and markers of metabolic dysfunction among patients at risk for preeclampsia.

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Key information

Conditions

Preeclampsia Body Weight Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Complications Gestational Diabetes Gestational Diabetes Mellitus in Pregnancy Glucose Metabolism Disorders Hypertension, Pregnancy-Induced Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity and Obesity-related Medical Conditions Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pre-Eclampsia Preeclampsia (PE) Preeclampsia (PE) Risk Pregnancy Pregnancy Complications Pregnancy in Obesity Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location status: Recruiting

Location contact

Rebecca Purvis, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hexadecadienoate (z score)

    Time frame: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age

    Hexadecadienoate (long chain poly unsaturated fatty acid metabolite obtained from metabolomics assay) (z score)

  2. Salicylate (z score)

    Time frame: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age

    Salicylate (benzoate metabolite obtained from metabolomics assay)(z score)

Secondary outcomes

  1. Urinary thromboxane B2 level (pg/mg creat)

    Time frame: 60 minutes after ingestion of 75 grams of glucose, during a single study visit between 14-20 weeks gestational age

    Urinary thromboxane B2 level (pg/mg creat)

  2. Fasting Salicylate level (ug/mL)

    Time frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age

    Fasting Salicylate level (ug/mL) in venous blood

  3. 1 Hour Salicylate level (ug/mL)

    Time frame: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age

    1 Hour Salicylate level (ug/mL) in venous blood

  4. 2 Hour Salicylate level (ug/mL)

    Time frame: 120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age

    2 Hour Salicylate level (ug/mL) in venous blood

  5. Fasting PFA-100 epinephrine closure time

    Time frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age

    Fasting PFA-100 epinephrine closure time in venous blood

  6. 1 Hour PFA-100 epinephrine closure time

    Time frame: 60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age

    1 Hour PFA-100 epinephrine closure time in venous blood

  7. 2 Hour PFA-100 epinephrine closure time

    Time frame: 120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age

    2 Hour PFA-100 epinephrine closure time in venous blood

  8. Homeostatic Model Assessment for Insulin Resistance

    Time frame: Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 14-20 weeks gestational age

    Approximates insulin resistance.

  9. Fasting Resting Metabolic Rate

    Time frame: Measured at the start of a single study visit between 14-20 weeks gestational age

    Resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry

  10. Fasting Respiratory Quotient

    Time frame: Measured at the start of a single study visit between 14-20 weeks gestational age

    Resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry

  11. Fasting Carbohydrate Oxidation Rate

    Time frame: Measured at the start of a single study visit between 14-20 weeks gestational age

    Fasting carbohydrate oxidation rate measures whole body carbohydrate oxidation, which is assessed using indirect calorimetry

  12. Fasting Lipid Oxidation Rate

    Time frame: Measured at the start of a single study visit between 14-20 weeks gestational age

    Fasting lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry

  13. Fasting Insulin (mIU/mL)

    Time frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age

    Fasting insulin level (mIU/mL) in venous blood

  14. Fasting glucose (mg/dL)

    Time frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age

    Fasting glucose level (mg/dL) in venous blood

  15. Fasting lactate (mmol/L)

    Time frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age

    Fasting lactate level (mmol/L) in venous blood

  16. Fasting triglycerides (mg/dL)

    Time frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age

    Fasting triglycerides level (mg/dL) in venous blood

  17. Fasting high density lipoprotein (mg/dL)

    Time frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age

    Fasting high density lipoprotein level (HDL) (mg/dL) in venous blood

  18. Fasting very low density lipoprotein (mg/dL)

    Time frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age

    Fasting very low density lipoprotein level (VLDL) (mg/dL) in venous blood

  19. Fasting low density lipoprotein (mg/dL)

    Time frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age

    Fasting low density lipoprotein level (LDL) (mg/dL) in venous blood

  20. Fasting cholesterol (mg/dL)

    Time frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age

    Fasting cholesterol level (mg/dL) in venous blood

  21. Fasting free fatty acids (mEq/L)

    Time frame: Fasting, at the beginning of a single study visit between 14-20 weeks gestational age

    Fasting free fatty acids (FFA) (mEq/L) in venous blood

Study contacts

Contact information is provided by the study sponsor or research team.

Jill M Maples, PhD

CONTACT

[email protected]

865-305-9367

Sponsors and collaborators

Lead sponsor

University of Tennessee Graduate School of Medicine

Other

Registry information

Acronym: RAMP

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jan 31, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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