NCT07565727Recruiting
Cardiometabolic Disease and Substrate Metabolism
Cardiometabolic Disease, Substrate Metabolism, and Abnormal Placental Pathology: a Multimodal Maternal-Fetal Study
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 27 Apr 2026
- Start date
- 10 Dec 2025
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- NCT number
- NCT07565727
What you commit to
- Study type: Observational
- Planned participants: 50
- From 10 Dec 2025 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of other immune-modulating agents and biologics (hydroxychloroquine, azathioprine, 6-mercaptopurine, IL-6 inhibitors, etc.)
- Current or recent use of steroids
- Medical contraindication to aspirin therapy
Other illness
- Type 2 Diabetes Mellitus
- Type 1 Diabetes Mellitus
- Current gestational diabetes mellitus
- Renal disease
- Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principal investigators
Lab values
- Current/active platelet disorder or bleeding diathesis (thrombocytopenia of any etiology, idiopathic thrombocytopenic purpura/ITP, thrombotic thrombocytopenic purpura/TTP, von Willebrand disease, etc.)
Other
- Thrombophilia
- Current use of NSAID for other indication (indomethacin, ibuprofen, etc.)
- Current use of prophylactic or therapeutic anticoagulation
- Molar pregnancy
- Inability or unwillingness to give informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Tennessee Graduate School of Medicine Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.