Understanding how triglycerides in pregnancy affect newborn fat
The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy
This study is trying to see how the triglyceride levels in pregnant women affect the amount of fat their newborns have.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 0 Years to 39 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04394806 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between maternal triglyceride levels during pregnancy and the fat mass of newborns. Pregnant women will monitor their triglyceride and glucose levels at home using point-of-care meters. Two weeks after delivery, the newborns will undergo measurements of total fat and liver fat using advanced techniques. The study hypothesizes that both fasting and postprandial triglycerides will be significant predictors of newborn fat mass in mothers with obesity.
Who should consider this trial
Good fit: Ideal candidates are pregnant women under 16 weeks gestational age, aged 21-39 years, with a pre-pregnancy BMI between 28-39 kg/m2.
Not a fit: Patients with pre-gestational diabetes, a history of gestational diabetes, or other significant pregnancy complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of newborn fat mass, potentially reducing obesity-related complications in infants.
How similar studies have performed: While there is existing data suggesting maternal triglycerides are important, this specific approach to monitoring and measuring newborn fat mass is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- University of Colorado/Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Linda A Barbour, MD, MSPH — University of Colorado, Denver
- Study coordinator: Emily Z Dunn, MS, RDN
- Email: Emily.2.Dunn@cuanschutz.edu
- Phone: 303-724-0320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.