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临床试验/NCT04394806
NCT04394806招募中不适用

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

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
2
主要终点
Newborn Fat Mass

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 39 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pregnant women less than 16 weeks gestational age
  • Between the ages of 21-39 years
  • Pre-pregnancy BMI 28-39 kg/m2

排除标准

  • 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

结局指标

主要结局

Newborn Fat Mass

时间窗: 7-14 days after birth

Newborn fat mass measured by air displacement plethysmography (PeaPod)

次要结局

  • Newborn Intrahepatic Fat(7-14 days after birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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