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

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

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Pregnancy; Preeclampsia; Gestational Diabetes; Gestational Diabetes Mellitus in Pregnancy; Preeclampsia (PE); Obesity and Obesity-related Medical Conditions; Gestational Complications; Preeclampsia (PE) Risk

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Jill M Maples, PhD; Phone Number: 865-305-9367; Email: jmaples1@utmck.edu

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee Medical Center
      • Contact: Rebecca Purvis, MD; Email: rpurvis@utmck.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant individuals at risk for preeclampsia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pregnant individuals at risk for preecampsia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hexadecadienoate (z score)	Hexadecadienoate (long chain poly unsaturated fatty acid metabolite obtained from metabolomics assay) (z score)	60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
Salicylate (z score)	Salicylate (benzoate metabolite obtained from metabolomics assay)(z score)	60 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary thromboxane B2 level (pg/mg creat)	Urinary thromboxane B2 level (pg/mg creat)	60 minutes after ingestion of 75 grams of glucose, during a single study visit between 14-20 weeks gestational age
Fasting Salicylate level (ug/mL)	Fasting Salicylate level (ug/mL) in venous blood	Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
1 Hour Salicylate level (ug/mL)	1 Hour Salicylate level (ug/mL) in venous blood	60 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)	2 Hour Salicylate level (ug/mL) in venous blood	120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
Fasting PFA-100 epinephrine closure time	Fasting PFA-100 epinephrine closure time in venous blood	Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
1 Hour PFA-100 epinephrine closure time	1 Hour PFA-100 epinephrine closure time in venous blood	60 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	2 Hour PFA-100 epinephrine closure time in venous blood	120 minutes after ingestion of 75 grams of glucose during a single study visit between 14-20 weeks gestational age
Homeostatic Model Assessment for Insulin Resistance	Approximates insulin resistance.	Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 14-20 weeks gestational age
Fasting Resting Metabolic Rate	Resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry	Measured at the start of a single study visit between 14-20 weeks gestational age
Fasting Respiratory Quotient	Resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry	Measured at the start of a single study visit between 14-20 weeks gestational age
Fasting Carbohydrate Oxidation Rate	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 14-20 weeks gestational age
Fasting Lipid Oxidation Rate	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 14-20 weeks gestational age
Fasting Insulin (mIU/mL)	Fasting insulin level (mIU/mL) in venous blood	Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting glucose (mg/dL)	Fasting glucose level (mg/dL) in venous blood	Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting lactate (mmol/L)	Fasting lactate level (mmol/L) in venous blood	Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting triglycerides (mg/dL)	Fasting triglycerides level (mg/dL) in venous blood	Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting high density lipoprotein (mg/dL)	Fasting high density lipoprotein level (HDL) (mg/dL) in venous blood	Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting very low density lipoprotein (mg/dL)	Fasting very low density lipoprotein level (VLDL) (mg/dL) in venous blood	Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting low density lipoprotein (mg/dL)	Fasting low density lipoprotein level (LDL) (mg/dL) in venous blood	Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting cholesterol (mg/dL)	Fasting cholesterol level (mg/dL) in venous blood	Fasting, at the beginning of a single study visit between 14-20 weeks gestational age
Fasting free fatty acids (mEq/L)	Fasting free fatty acids (FFA) (mEq/L) in venous blood	Fasting, at the beginning of a single study visit between 14-20 weeks gestational age

Collaborators and Investigators

• Sponsor: University of Tennessee Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): January 31, 2025

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: pregnancy; gestational diabetes; GDM; metabolic dysfunction; substrate oxidation; maternal obesity; maternal insulin resistance; aspirin metabolism; gestational glucose intolerance
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Nutrition Disorders; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Hypertension, Pregnancy-Induced; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes, Gestational; Pre-Eclampsia; Pregnancy Complications; Pregnancy in Obesity
• Other Study ID Numbers: 5316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Reasonable requests will be considered on a case-by-case basis.
• IPD Sharing Time Frame: We anticipate publishing the study protocol within the next 2 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No