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

NCT04394806 | Recruiting

• 1 other identifier: 20-0706
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Newborn Fat Mass

  Newborn fat mass measured by air displacement plethysmography (PeaPod)

  7-14 days after birth

Secondary Outcomes (1)

• Newborn Intrahepatic Fat

  7-14 days after birth

Eligibility Criteria

• Age: 0 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Overweight and obese pregnant women between the ages of 20-39 years old, who are receiving care at a University of Colorado Health Facility.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado/Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (1)

• Barbour LA, Farabi SS, Friedman JE, Hirsch NM, Reece MS, Van Pelt RE, Hernandez TL. Postprandial Triglycerides Predict Newborn Fat More Strongly than Glucose in Women with Obesity in Early Pregnancy. Obesity (Silver Spring). 2018 Aug;26(8):1347-1356. doi: 10.1002/oby.22246. Epub 2018 Jun 22.

  PMID: 29931812 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, cord blood, cord and placental tissue,

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Linda A Barbour, MD, MSPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Teri L Hernandez, PhD, RN

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Z Dunn, MS, RDN

CONTACT

303-724-0320; Emily.2.Dunn@cuanschutz.edu

Nicole Hirsch, MS

CONTACT

303-724-0572; Nicole.Hirsch@cuanschutz.edu

Study Design

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

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 19, 2020
• Study Start: March 1, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)