Trans-placental Transport and Foetal Accumulation of Artificial Sweeteners
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
- 是
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
