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

May 9, 2023 updated by: University of Colorado, Denver
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado/Anschutz Medical Campus
        • Contact:
        • Sub-Investigator:
          • Linda A Barbour, MD, MSPH
        • Principal Investigator:
          • Teri L Hernandez, PhD, RN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 39 years (Child, Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Linda A Barbour, MD, MSPH, University of Colorado, Denver
  • Principal Investigator: Teri L Hernandez, PhD, RN, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

July 1, 2027

Study Completion (Anticipated)

July 1, 2027

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20-0706

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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