Clinical Trial: Regulation Of Maternal Fuel Supply And Neonatal Adiposity
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Regulation Of Maternal Fuel Supply And Neonatal Adiposity
Brief Summary: The purpose of this study is to determine whether unrecognized maternal hyperglycemia and postprandial lipemia early or late in gestation predicts excess neonatal adiposity.
Detailed Summary: Mounting epidemiologic evidence suggests that maternal obesity and Gestational Diabetes Mellitus (GDM) independently influence size at birth and disease susceptibility later in life. A major gap in the understanding of fetal programming is the knowledge of whether and how exposure to excess maternal fuels in the absence of frank hyperglycemia impacts fetal fat accretion. The investigators hypothesis is that neonatal adiposity results from unrecognized maternal hyperglycemia and excess lipid availability in gestation, in part caused by excessive lipolysis in the white adipose tissue of obese women, some of whom will be subsequently diagnosed as having GDM. In Aim 1 the investigators will test the hypothesis that in obese women, some of whom will later be diagnosed with GDM, increased lipolysis and unrecognized hyperglycemia and hypertriglyceridemia occur earlier in gestation than in lean women, resulting in increased plasma non-esterified fatty acids (NEFA), glycerol, triglycerides (TGs), and glucose available for fetal metabolism. In Aim 2 the investigators will test the hypothesis that fetal adiposity by ultrasound and neonatal adiposity by Dual-energy X-ray Absorptiometry (DXA) are strongly correlated with excess lipid and glucose availability in obese mothers early in gestation, regardless of GDM status, and that fasting biomarkers of neonatal insulin sensitivity will correlate with neonatal adiposity. In Aim 3 the investigators will test the hypothesis that the in-vitro suppression of lipolysis in white adipose tissue correlates with excess NEFA and TG availability in-vivo and is predictive of neonatal adiposity. The elucidation of specific derangements in both glucose and lipid metabolism and their timing in gestation in mothers who deliver infants with excess adiposity could challenge our current screening methods and entirely redirect our treatment to target the responsible maternal fuels. On a public health level, this research is instrumental to the investi
Sponsor: University of Colorado, Denver
Current Primary Outcome:
- Change in neonatal adiposity by maternal Triglycerides, Glucose [ Time Frame: 14-16, 26-28 weeks gestation ]Prediction of neonatal adiposity by maternal Triglycerides and Glucose
- Change in maternal postprandial lipemia [ Time Frame: 26-28 weeks gestation ]
Original Primary Outcome:
- Maternal postprandial lipemia [ Time Frame: Early and late gestation ]
- Maternal and neonatal body fat [ Time Frame: 2wk postpartum ]
Current Secondary Outcome:
- Change in maternal postprandial lipemia [ Time Frame: 14-16, 26-28 weeks gestation ]
- Change in maternal postprandial glycemia [ Time Frame: 14-16, 26-28 weeks gestation ]
- Prediction of neonatal adiposity by placental and maternal adipose tissue lipoprotein lipase (LPL) activity [ Time Frame: 26-28 weeks gestation ]adipose tissue biopsy/Neonatal adiposity by Dual x-ray Absorptiometry (DXA)
- Correlation of neonatal adiposity and fetal growth [ Time Frame: 28-30 weeks gestation ]Neonatal adiposity by Dual-energy X-ray Absorptiometry (DXA)
- Correlation of neonatal adiposity and fetal growth [ Time Frame: 36-37 weeks gestation ]Neonatal adiposity by Dual-energy X-ray Absorptiometry (DXA)
Original Secondary Outcome:
- Adipose tissue LPL activity [ Time Frame: Late gestation ]
- Neonatal liver ultrasound [ Time Frame: 48hr after birth ]
- 72-hr continuous glucose [ Time Frame: Early and late gestation ]
Information By: University of Colorado, Denver
Dates:
Date Received: January 21, 2009
Date Started: October 2007
Date Completion: October 2017
Last Updated: April 12, 2017
Last Verified: April 2017
