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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04394806
• Other study ID #: 20-0706
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: July 2027

Study information

• Verified date: May 2023
• Source: University of Colorado, Denver
• Contact: Emily Z Dunn, MS, RDN
• Phone: 303-724-0320
• Email: Emily.2.Dunn[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
United States	University of Colorado/Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Newborn Fat Mass	Newborn fat mass measured by air displacement plethysmography (PeaPod)	7-14 days after birth
Secondary	Newborn Intrahepatic Fat	Newborn intrahepatic fat measured by Magnetic Resonance Spectroscopy (MRS)	7-14 days after birth