Actively Recruiting
Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study
Led by University of Tennessee Graduate School of Medicine · Updated on 2026-05-04
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cardiometabolic diseases like pre-eclampsia and gestational diabetes affect about 15% of pregnancies and can cause serious problems for mothers and newborns. This research aims to understand how insulin resistance and maternal fat metabolism relate to these conditions. It focuses on early pregnancy and looks beyond typical glucose tests to include various metabolic factors and placental function, offering a broader view of disease development during pregnancy. Pregnant individuals at risk for cardiometabolic disease will be observed during two visits: one between 12 and 18 weeks and another between 26 and 30 weeks of pregnancy. During these visits, fasting blood tests will measure insulin, glucose, lipid metabolism, and other metabolic markers. Additional assessments include indirect calorimetry, body composition, and neonatal measures. The study also examines placental pathology to understand the maternal, fetal, and placental interactions in disease development. Participants will attend two study visits where fasting blood samples and metabolic tests are collected. Researchers will measure insulin resistance, lipid oxidation rates, resting metabolic rates, various blood lipids, and glucose levels. Survey data and body composition will also be gathered. The study monitors maternal and neonatal outcomes related to cardiometabolic health, with the goal of identifying early markers and mechanisms. Participation lasts through these visits during pregnancy, with no treatment interventions involved.
CONDITIONS
Brief Title
Cardiometabolic Disease and Substrate Metabolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-45 years
- Any pre-pregnancy body mass index
- At least one high or moderate risk factor for pre-eclampsia based on ACOG and USPSTF guidelines
- Willingness to adhere to aspirin therapy
- Willingness to undergo 2-hour oral glucose tolerance test and other assessments
- Gestational age less than 18 weeks at enrollment
- Ability to speak, read, and communicate in English
You will not qualify if you...
- Type 1 or type 2 diabetes mellitus
- Current gestational diabetes mellitus
- Active platelet disorder or bleeding problems
- Thrombophilia
- Current use of NSAIDs or immune-modulating agents
- Current or recent use of steroids
- Current use of anticoagulation therapy
- Medical reasons preventing aspirin use
- Molar pregnancy
- Kidney disease
- Inability or unwillingness to provide informed consent
- Current psychiatric or social issues limiting study compliance
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 18 weeks gestational age
Participants are screened for eligibility to participate in the trial.
Duration - From 12 to 30 weeks gestational age
Participants undergo metabolic and cardiometabolic assessments during early and late pregnancy to evaluate substrate metabolism and placental function.
2 visits (in-person): one between 12-18 weeks and one between 26-30 weeks gestational age
Trial Site Locations
Total: 1 location
1
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, United States, 37920
Actively Recruiting
Research Team
J
Jill M Maples, PhD
H
Hana O El-Messidi, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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