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NCT Number: NCT04394806

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

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.

Recruiting

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Key information

Age range

0 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado/Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Emily Dunn, MS, RDN

CONTACT

[email protected]

303-724-0320

Linda A Barbour, MD, MSPH

SUB_INVESTIGATOR

Teri L Hernandez, PhD, RN

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Newborn Fat Mass

    Time frame: 7-14 days after birth

    Newborn fat mass measured by air displacement plethysmography (PeaPod)

Secondary outcomes

  1. Newborn Intrahepatic Fat

    Time frame: 7-14 days after birth

    Newborn intrahepatic fat measured by Magnetic Resonance Spectroscopy (MRS)

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Z Dunn, MS, RDN

CONTACT

[email protected]

303-724-0320

Nicole Hirsch, MS

CONTACT

[email protected]

303-724-0572

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 19, 2020
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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