Maternal insulin and fat metabolism in pregnancies at risk for preeclampsia and gestational diabetes
Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study
This project will try to see if insulin resistance and how the body burns fats early in pregnancy predict later preeclampsia or gestational diabetes in people at higher risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Tennessee Graduate School of Medicine Academic / other |
| Locations | 1 site (Knoxville, Tennessee) |
| Trial ID | NCT07565727 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: People aged 18–45 with a pregnancy under 18 weeks who have at least one ACOG/USPSTF moderate or high risk factor for preeclampsia, who are willing to take aspirin and complete the required glucose testing and metabolic measurements, are ideal candidates.
Not a fit: People with preexisting type 1 or type 2 diabetes, current gestational diabetes, active bleeding or platelet disorders, thrombophilia, or those taking excluded medications are unlikely to benefit from this observational protocol.
Why it matters
Potential benefit: If successful, this work could help identify metabolic signals early in pregnancy that predict later cardiometabolic complications, allowing earlier personalized prevention and monitoring.
How similar studies have performed: Previous research has linked maternal glucose and lipid levels to fetal growth and pregnancy outcomes, but few studies have specifically tied maternal lipid oxidation and HOMA-IR early in pregnancy to later preeclampsia or gestational diabetes, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Knoxville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.