Cardiometabolic Disease and Substrate Metabolism Study

This observational study is looking at the connection between cardiometabolic diseases, like preeclampsia (high blood pressure during pregnancy) and gestational diabetes (diabetes that develops during pregnancy), and how your body uses fats for energy (maternal lipid oxidation). Researchers want to understand if insulin resistance (when your body doesn't respond well to insulin) is related to how your body processes fats early in pregnancy. You might be able to join if you are a woman between 18 and 45 years old, have certain risk factors for preeclampsia, and are willing to take aspirin and undergo specific tests. The study aims to measure your fasting insulin, insulin resistance, and how quickly your body uses fats for energy early in your pregnancy. The current status of this study is unclear, and it plans to enroll 50 participants.

Study design
This is an observational study, meaning researchers will observe participants without providing specific interventions. It plans to include 50 women.
What's involved
You would need to agree to take aspirin and undergo a 2-hour oral glucose tolerance test (OGTT) for blood collection, surveys, indirect calorimetry (to measure metabolism), and body composition measures. These measurements would occur during a single study visit between 12-18 weeks of gestational age.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at the beginning of a single study visit between 12-18 weeks gestational age. No further follow-up is specified.

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NCT07565727

Cardiometabolic Disease and Substrate Metabolism

Recruiting
Not specifiedAges 18–45Observational
University of Tennessee Graduate School of Medicine
~50 participants
Updated 2026-05-04 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Early Pregnancy Fasting Insulin (mIU/mL)
Measured over Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
+5 more outcomes measured
Preeclampsia
Gestational Diabetes Mellitus (GDM)
Preeclampsia (PE)
Preeclampsia (PE) Risk
Gestational Diabetes
Gestational Diabetes Mellitus in Pregnancy
Cardiometabolic Diseases
Insulin Resistance
Placental Dysfunction
Pregnancy
Pregnancy Complications
Gestational Complications
1 sites across 1 states
Tennessee1

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Eligibility criteria

Inclusion

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

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
  • Early Pregnancy Fasting Insulin (mIU/mL)Fasting, at the beginning of a single study visit between 12-18 weeks gestational age

    Early pregnancy fasting insulin level (mIU/mL) in venous blood

  • Early Pregnancy Homeostatic Model Assessment for Insulin ResistanceCalculated from fasting insulin and fasting glucose collected at the start of a single study visit between 12-18 weeks gestational age

    Approximates early pregnancy insulin resistance.

  • Early Pregnancy Fasting Lipid Oxidation Rate (g/min)Measured at the start of a single study visit between 12-18 weeks gestational age

    Early pregnancy fasting lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry

  • Late Pregnancy Fasting Insulin (mIU/mL)Fasting, at the beginning of a single study visit between 26-30 weeks gestational age

    Late pregnancy fasting insulin level (mIU/mL) in venous blood

  • Late Pregnancy Homeostatic Model Assessment for Insulin ResistanceCalculated from fasting insulin and fasting glucose collected at the start of a single study visit between 26-30 weeks gestational age

    Approximates late pregnancy insulin resistance.

  • Late Pregnancy Fasting Lipid Oxidation Rate (g/min)Measured at the start of a single study visit between 26-30 weeks gestational age

    Fasting late pregnancy lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry