Maternal insulin and fat metabolism in pregnancies at risk for preeclampsia and gestational diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study enrolls pregnant people before 18 weeks' gestation who have at least one moderate or high risk factor for preeclampsia. Participants will undergo a 2-hour oral glucose tolerance test with blood draws to calculate HOMA-IR, plus measurements of lipid profiles, indirect calorimetry for substrate oxidation, and body composition; neonatal measures and surveys will also be collected. The aim is to link patterns of glucose and lipid metabolism, including maternal lipid oxidation, with later development of preeclampsia or gestational diabetes. No experimental treatments are given; standard-of-care aspirin prophylaxis is part of the protocol for eligible participants.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Tennessee Graduate School of Medicine
  Knoxville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Jill M Maples, PhD
• Email: jmaples1@utmck.edu
• Phone: 865-305-9367

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.