NCT04394806 The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy
| NCT ID | NCT04394806 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Pregnancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2022-03-01 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Linda A Barbour, MD, MSPH
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT04394806 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 39 Years, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04394806 currently recruiting?
Yes, NCT04394806 is actively recruiting participants. Contact the research team at Emily.2.Dunn@cuanschutz.edu for enrollment information.
Where is the NCT04394806 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT04394806 clinical trial?
NCT04394806 is sponsored by University of Colorado, Denver. The principal investigator is Linda A Barbour, MD, MSPH at University of Colorado, Denver. The trial plans to enroll 140 participants.