跳至主要内容
临床试验/NCT04302168
NCT04302168已完成不适用

Effects of Choline Supplementation on Fetal Growth in Gestational Diabetes Mellitus

Maimonides Medical Center2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Birthweight

研究概览

简要总结

Gestational diabetes mellitus (GDM), characterized by maternal high blood sugar, affects up to 15% of pregnancies worldwide. GDM doubles the risk of fetal growth (i.e. macrosomia, large fetus,) which further predisposes the affected fetus to elevated risks of obesity, diabetes and cardiovascular disease later in life. The placenta mediates macrosomia by increasing fat and glucose transport to the fetus during GDM. Effective methods to normalize placental nutrient transport and prevent macrosomia are lacking. Choline is a semi-essential nutrient found in egg yolks, meat, fish and cruciferous vegetables. The demand for this nutrient increases substantially during pregnancy. Previous research demonstrated that maternal choline supplementation (MCS) normalized placental fat and glucose transport as well as fetal growth and fat mass in GDM mice. In this study, the investigators will recruit pregnant women with GDM and randomized them to receive a choline supplement (470mg/day, a dose with demonstrated safety), or a placebo for 8 weeks, starting after gestational week 28. The investigators will determine the effects of choline on fetal growth as well as the influence of choline on placental transport and epigenetic modifications in growth-related genes in the placenta and umbilical cord. Successful completion of this study will provide valuable insights into the use of choline supplement as a modifier of placental macronutrient homeostasis in GDM to improve fetal growth outcomes.

详细描述

STUDY OBJECTIVES Specific Aim 1: Determine the effect of MCS during pregnancy on birth weight in GDM.

Specific Aim 2: Determine the influence of MCS on macronutrient transport and epigenetic modifications in the placenta and cord blood.

HYPOTHESIS

Aim 1: The investigators hypothesize that the choline group would have lower birth weight and fewer LGA neonates than the non- choline group.

Aim 2: The investigators hypothesize that the choline group would reduce placental transport and increase DNA methylation of metabolic genes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • GDM pregnant women before gestational week
  • English or Spanish speaking, over 18 years of age
  • singleton pregnancy
  • intending to deliver their babies at Maimonides Medical Center

排除标准

  • pre-existing hyperglycemia
  • cardiovascular conditions and liver disease prior to pregnancy.

结局指标

主要结局

Birthweight

时间窗: At time of birth

Birthweight of neonate

次要结局

  • Gene expression of glucose transporters(At time of birth)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Itamar Futterman

Principal Investigator

Maimonides Medical Center

研究点 (2)

Loading locations...

相似试验

Choline Supplementation on Fetal Growth in... | 临床试验