The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04394806

Enrollment

140

Registered

2020-05-19

Start date

2022-03-01

Completion date

2027-07-01

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Triglycerides, Glucose, Adiposity, Air displacement plethysmography, Continuous glucose monitoring

Brief summary

This study plans to learn more about how triglyceride levels in pregnancy affect newborn fat mass. Obesity in pregnancy, in the absence of gestational diabetes, is now the most common cause of large-for-gestational-age infants and increased newborn fat mass. Previous data supports the idea that maternal triglycerides, not glucose, are the strongest predictor of both total newborn fat mass and liver fat. In this study, mothers will monitor triglyceride and glucose levels at specific points in pregnancy using point-of-care meters at home. Two weeks after birth, infants will have total fat measured by air-displacement plethysmography (PEAPOD) and liver fat measures by Magnetic Resonance Spectroscopy (MRS). The central hypothesis is that in obesity, fasting triglycerides and postprandial triglycerides will predict newborn fat mass in a free-living environment.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to 39 Years

Healthy volunteers

Yes

Inclusion criteria

* Pregnant women less than 16 weeks gestational age * Between the ages of 21-39 years * Pre-pregnancy BMI 28-39 kg/m2

Exclusion criteria

* Pre-gestational diabetes or prediabetes * History of gestational diabetes * History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension \<34wks * Tobacco or illicit substance use * Chronic steroid use

Design outcomes

Primary

Measure	Time frame	Description
Newborn Fat Mass	7-14 days after birth	Newborn fat mass measured by air displacement plethysmography (PeaPod)

Secondary

Measure	Time frame	Description
Newborn Intrahepatic Fat	7-14 days after birth	Newborn intrahepatic fat measured by Magnetic Resonance Spectroscopy (MRS)

Countries

United States

Contacts

CONTACTEmily Z Dunn, MS, RDN

Emily.2.Dunn@cuanschutz.edu303-724-0320

CONTACTNicole Hirsch, MS

Nicole.Hirsch@cuanschutz.edu303-724-0572

PRINCIPAL_INVESTIGATORLinda A Barbour, MD, MSPH

University of Colorado, Denver

PRINCIPAL_INVESTIGATORTeri L Hernandez, PhD, RN