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

NCT06802861 | Recruiting

• 1 other identifier: 5316
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (21)

• 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, at the beginning of a single study visit between 14-20 weeks gestational age

• 1 Hour Salicylate level (ug/mL)

  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)

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

Study Arms (1)

Pregnant individuals at risk for preecampsia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Limited to the biological sex of female, during pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant individuals at risk for preeclampsia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Pre-Eclampsia; Obesity; Pregnancy Complications; Diabetes, Gestational; Pregnancy in Obesity

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Jill M Maples, PhD

CONTACT

865-305-9367; jmaples1@utmck.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 31, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We anticipate publishing the study protocol within the next 2 years

Locations

US (1)