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临床试验/NCT03954418
NCT03954418已完成不适用

Trans-placental Transport and Foetal Accumulation of Artificial Sweeteners

University of Aarhus2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年6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
35
试验地点
2
主要终点
Mothers blood

研究概览

简要总结

With obesity on the rise worldwide more and more young women are also affected, leading to a higher prevalence of obese pregnant women and pregnant women with diabetes.

Children of these women are in risk of developing obesity during childhood which again leads to overweight during adult life resulting in life-style related diseases such as diabetes and cardio-vascular disease.

Overweight and diabetic women are currently advised to substitute sugar sweetened beverages with artificially sweetened beverages to lower caloric intake and avoid fluctuations in blood glucose to avoid complications during pregnancy for both mother and child.

Recent studies suggest that high intake of artificial sweeteners during pregnancy increases the risk of the child developing obesity. If this is indeed true, the current guidelines have the opposite of the wanted and children already in risk of overweight are exposed to extra risk.

To investigate if artificial sweeteners can affect the foetus, the investigators wish to examine whether artificial sweeteners can cross the placenta.

The study is a clinical trial in which 40 women will be enrolled. 30 participants will drink a diet soft drink 2 hours before a caesarean section and 10 controls will refrain from intake. After birth the investigators will obtain a blood sample from the mother and from the umbilical cord and a placental biopsy and measure the contents of artificial sweeteners. Furthermore, the investigators will obtain a sample of amniotic fluid to examine if the sweeteners are excreted into the amniotic fluid.

The results ultimately have the potential to change the current guidelines on diet for overweight and diabetic women during pregnancy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Elective caesarean section
  • Child with IUGR (10 subjects)
  • Diabetes (10 subjects)
  • Other reasons for caesarean section(10 healthy subjects in intervention + 10 healthy controls)

排除标准

  • Acute caesarean section

结局指标

主要结局

Mothers blood

时间窗: Time of birth

Concentration of artificial sweeteners in blood from the mother

Placenta

时间窗: Time of birth

Concentration of artificial sweeteners in placenta

Umbilical cord

时间窗: Time of birth

Concentration of artificial sweeteners in blood from umbilical cord

Amniotic fluid

时间窗: Time of birth

Concentration of artificial sweeteners in amniotic fluid

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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