Influence of DHA/Oat on Maternal and Neonatal Metabolic Health in Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- neonatal leptin
研究概览
简要总结
The randomized controlled trial (RCT) recruits pregnant women with de novo diagnosis of gestational diabetes. Women bearing a singleton pregnancy are randomized into four arms: DHA, oat, oat plus DHA, and placebo. The primary outcomes are cord blood leptin concentration in the newborns and maternal fasting glucose levels at 8 weeks post-intervention.
详细描述
DHA is a long-chain fatty acid that has been shown to increase insulin sensitivity in basic science studies. Some studies have reported that oat (β-glucan) intake in patients with type 2 diabetes may improve glycaemic control. Evidence is emerging that gut microbiota may play an important role in energy homeostasis and glucose metabolism. This RCT aims to test the hypothesis that DHA and/or oat intake may improve glycemic control in women with gestational diabetes mellitus (GDM), and may impact metabolic health in fetuses/infants as indicated by cord blood leptin level. Changes in microbiota may be linked to these effects.
Growing evidence suggests that epigenetic changes may occur during fetal development in response to an adverse in utero environment, and this may "program" the risk of metabolic syndrome and type 2 diabetes in adulthood. GDM's offspring are programmed to be at substantially elevated risk of metabolic syndrome and type 2 diabetes in adulthood. We will explore whether the intervention may affect epigenetic profile in placental DNA in GDM.
Pregnant women bearing a singleton fetus without any evidence of malformation and with a de novo diagnosis of GDM at 22-28 weeks of gestation will be randomized into four arms: DHA, oat, oat plus DHA, and placebo. We will collect maternal blood and stool specimens on recruitment and 8-weeks post-intervention, cord blood and placenta specimens at delivery. The primary outcomes are cord blood leptin concentration in the baby, and fasting blood glucose at the 8 weeks post-intervention in the mother.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Han nationality
- •20-45 years old
- •singleton pregnancy
- •natural conception
- •the pregnant women with de novo diagnosis of gestational diabetes mellitus during 22-28 weeks of pregnancy
排除标准
- •Pregnant woman or the biological father has diabetes mellitus (Type I or II)
- •the woman has severe diseases or life threatening conditions such as HIV, cancer, renal failure
- •the fetus has known congenital malformation or genetic defects
- •in-vitro fertilization
- •active hepatitis
- •tuberculosis
- •drug abuser
- •multiple pregnancy
研究组 & 干预措施
nutritional guidance
routine care (all arms with nutritional guidance per routine care)
oat grains
90 mg oat, per day.
干预措施: oat grains (Dietary Supplement)
oat grains and DHA tablets
90 mg oat and 500 mg DHA oral tablets, per day.
干预措施: oat grains (Dietary Supplement)
DHA tablets
500 mg DHA oral tablets, per day.
干预措施: DHA (Dietary Supplement)
oat grains and DHA tablets
90 mg oat and 500 mg DHA oral tablets, per day.
干预措施: DHA (Dietary Supplement)
结局指标
主要结局
neonatal leptin
时间窗: at birth/delivery
cord blood leptin concentration
次要结局
- maternal fasting plasma glucose concentration(8 weeks post-intervention)