Cardiometabolic Disease and Substrate Metabolism

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity of Tennessee Graduate School of Medicine

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial population

Pregnant individuals at risk for preeclampsia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: Pregnant individuals at risk for cardiometabolic disease

Trial outcomes

Primary outcomes

1

Early Pregnancy Fasting Insulin (mIU/mL)

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

Time frame
Fasting, at the beginning of a single study visit between 12-18 weeks gestational age
2

Early Pregnancy Homeostatic Model Assessment for Insulin Resistance

Approximates early pregnancy 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
3

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

Time frame
Measured at the start of a single study visit between 12-18 weeks gestational age
4

Late Pregnancy Fasting Insulin (mIU/mL)

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

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

Secondary outcomes

1

Early Pregnancy Fasting Resting Metabolic Rate (kcal/day)

Early pregnancy resting metabolic rate describes whole body caloric expenditure, which is assessed using indirect calorimetry

Time frame
Measured at the start of a single study visit between 12-18 weeks gestational age
2

Early Pregnancy Fasting Resting Respiratory Quotient

Early pregnancy resting respiratory quotient describes whole body caloric expenditure, which is assessed using indirect calorimetry

Time frame
Measured at the start of a single study visit between 12-18 weeks gestational age
3

Early Pregnancy Fasting Carbohydrate Oxidation Rate (g/min)

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

Time frame
Measured at the start of a single study visit between 12-18 weeks gestational age
4

Early Pregnancy Fasting Glucose (mg/dL)

Early pregnancy fasting glucose level (mg/dL) in venous blood

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.