NCT07565727 · University of Tennessee Graduate School of Medicine
Cardiometabolic Disease and Substrate Metabolism
(CAP)
What this study is about
This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.
View original scientific description
This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.
Primary outcome measures
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 fasting insulin level (mIU/mL) in venous blood
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
Approximates early pregnancy insulin resistance.
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
Early pregnancy fasting lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry
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 fasting insulin level (mIU/mL) in venous blood
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
Approximates late pregnancy insulin resistance.
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
Fasting late pregnancy lipid oxidation rate measures whole body lipid oxidation, which is assessed using indirect calorimetry
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Knoxville, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations