Cardiometabolic Disease and Substrate Metabolism

NCT07565727 | Recruiting

• 1 other identifier: 5483
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.

Conditions

Gestational Diabetes; Preeclampsia; Gestational Diabetes Mellitus (GDM); Preeclampsia (PE); Preeclampsia (PE) Risk; Gestational Diabetes Mellitus in Pregnancy; Cardiometabolic Diseases; Insulin Resistance; Placental Dysfunction; Pregnancy; Pregnancy Complications; Gestational Complications

Keywords

Cardiometabolic disease; Substrate metabolism; Preeclampsia; Gestational Diabetes; Insulin resistance; HOMA-IR; Lipid oxidation; Placental dysfunction; Chorangiosis

Outcome Measures

Primary Outcomes (6)

• Early Pregnancy Fasting Insulin (mIU/mL)

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

  Fasting, at the beginning of a single study visit between 12-18 weeks gestational age

• Early Pregnancy Homeostatic Model Assessment for Insulin Resistance

  Approximates early pregnancy insulin resistance.

  Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 12-18 weeks gestational age

• Early Pregnancy Fasting Lipid Oxidation Rate (g/min)

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

  Measured at the start of a single study visit between 12-18 weeks gestational age

• Late Pregnancy Fasting Insulin (mIU/mL)

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

  Fasting, at the beginning of a single study visit between 26-30 weeks gestational age

• Late Pregnancy Homeostatic Model Assessment for Insulin Resistance

  Approximates late pregnancy insulin resistance.

  Calculated from fasting insulin and fasting glucose collected at the start of a single study visit between 26-30 weeks gestational age

• Late Pregnancy Fasting Lipid Oxidation Rate (g/min)

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

  Measured at the start of a single study visit between 26-30 weeks gestational age

Secondary Outcomes (22)

• Early Pregnancy Fasting Resting Metabolic Rate (kcal/day)

  Measured at the start of a single study visit between 12-18 weeks gestational age

• Early Pregnancy Fasting Resting Respiratory Quotient

  Measured at the start of a single study visit between 12-18 weeks gestational age

• Early Pregnancy Fasting Carbohydrate Oxidation Rate (g/min)

  Measured at the start of a single study visit between 12-18 weeks gestational age

• Early Pregnancy Fasting Glucose (mg/dL)

  Fasting, at the beginning of a single study visit between 12-18 weeks gestational age

• Early Pregnancy Fasting Lactate (mmol/L)

  Fasting, at the beginning of a single study visit between 12-18 weeks gestational age

Study Arms (1)

Pregnant individuals at risk for cardiometabolic disease

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Limited to the biological sex of female, during pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant individuals at risk for preeclampsia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead

Study Sites (1)

University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37920, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Pre-Eclampsia; Diabetes, Gestational; Insulin Resistance; Pregnancy Complications

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Central Study Contacts

Jill M Maples, PhD

CONTACT

865-305-9367; jmaples1@utmck.edu

Hana O El-Messidi, BS

CONTACT

865-305-5592; hel1@utmck.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We anticipate publishing the study protocol within the next 2 years

Locations

US (1)