Recruiting

Observational Study

Sponsor:

University of Tennessee Graduate School of Medicine

Code:

NCT07565727

Conditions

Preeclampsia

Gestational Diabetes Mellitus (GDM)

Preeclampsia (PE)

Preeclampsia (PE) Risk

Gestational Diabetes

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.

Conditions

Preeclampsia

Gestational Diabetes Mellitus (GDM)

Preeclampsia (PE)

Preeclampsia (PE) Risk

Gestational Diabetes

Study ID

NCT07565727

Start date

Dec 10, 2025

Status verified date

Jan, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Pregnant individuals at risk for cardiometabolic disease

Primary outcome measure

  • Early Pregnancy Fasting Insulin (mIU/mL) [ Time Frame: Fasting, at the beginning of a single study visit between 12-18 weeks gestational age ]
  • Early Pregnancy 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 12-18 weeks gestational age ]
  • Early Pregnancy Fasting Lipid Oxidation Rate (g/min) [ Time Frame: Measured at the start of a single study visit between 12-18 weeks gestational age ]
  • Late Pregnancy Fasting Insulin (mIU/mL) [ Time Frame: Fasting, at the beginning of a single study visit between 26-30 weeks gestational age ]
  • Late Pregnancy 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 26-30 weeks gestational age ]
  • Late Pregnancy Fasting Lipid Oxidation Rate (g/min) [ Time Frame: Measured at the start of a single study visit between 26-30 weeks gestational age ]

Central Contacts and Locations

Central contacts

Jill M Maples, PhD

865-305-9367jmaples1@utmck.edu

Hana O El-Messidi, BS

865-305-5592hel1@utmck.edu

Locations

University of Tennessee Graduate School of Medicine

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Jill M Maples, PhD

865-305-9367jmaples1@utmck.edu

Hana O El-Messidi, BS

865-305-5592hel1@utmck.edu

Principal Investigator:

Jacklyn Locklear, MD

More Information

Sponsor

University of Tennessee Graduate School of Medicine

Last update posted

May 4, 2026

Last verified

Jan, 2026

Keywords

  • Cardiometabolic disease
  • Substrate metabolism
  • Preeclampsia
  • Gestational Diabetes
  • Insulin resistance
  • HOMA-IR
  • Lipid oxidation
  • Placental dysfunction
  • Chorangiosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Tennessee Graduate School of Medicine on 2026-05-04.