Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT04394806

Conditions

Pregnancy

Eligibility Criteria

Sex: All

Age: 0 - 39

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Pregnancy

Study ID

NCT04394806

Start date

Mar 1, 2022

Status verified date

May, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 39

Healthy Volunteers: Accepted

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

Study Design

Enrollment

140 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Newborn Fat Mass [ Time Frame: 7-14 days after birth ]

Central Contacts and Locations

Central contacts

Locations

University of Colorado/Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Teri L Hernandez, PhD, RN

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-05-12.