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临床试验/NCT04028089
NCT04028089Unknown不适用

Nutritional Prevention of Gestational Diabetes Mellitus

University Hospital Tuebingen2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年7月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Glycaemic excursion during an oral glucose tolerance test

研究概览

简要总结

Pregnancy is a vulnerable period for both a mother and her developing child. The investigator hypothesizes that diet-induced glucose excursions in the pregnant mother are a key contributor to unfavourable brain development and epigenetic marks in the developing child. It is long known that metabolic conditions are influenced by maternal nutrition and that this can impact the unborn infant. The most prominent example is gestational diabetes (GDM). It is unclear at what point unfavourable changes in brain development occur during pregnancy. Unlike many previous trials, we plan to introduce healthy diet early in the first trimester. Comparative analyses of DNA methylation patterns in the offspring of women with or without GDM revealed preferentially methylated genes, particularly in pathways linked to metabolic diseases.

NuPreGDM is a randomized, controlled, open label intervention trail. The investigator aims to assess the effect of individual diet counselling combined with CGM compared to regular diet on glucose levels and postprandial glycemic excursions during an OGTT in pregnancy.

The investigator wants to assess the effect of dietary counselling combined with continuous glucose monitoring on GDM risk, glycaemia and pregnancy outcome, starting in the first trimester. The investigator further hypothesizes that improved glucose levels by a healthy diet will affect brain activity of the infant and prevent unfavourable epigenetic modifications.

The investigator plans to include 50 pregnant women within gestational week 4 and 14 after the last menstruation, with elevated risk for development of (GDM). Participants will be randomized 1:1 to either "diet modification group" (intervention) or to "standard diet group" (control). In the current trial, the investigator aims to modulate maternal metabolism with periodic personalized diet counselling on the basis of continuous glucose monitoring (CGM) compared to regular diet throughout pregnancy. The investigator propose that a reduction in glucose excursions in the mother will lead to a healthy environment for the developing child and prevent altered brain activity in utero, which will be assessed by fMEG (fetal magnetoencephalography) during a 75g OGTT in gestational week 28. The investigator further planned to examine child's leucocytes from cord blood to assess whether a healthy diet of the mother prevented epigenetic alterations due to improved maternal glycaemia, as exploratory endpoint. The development of blood sugar levels of the mother postpartum will be assessed by an further OGTT 6-12 weeks postpartum.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women between gestational week 4 and 14 after the last menstruation (proof of b-human choriongonadotropin in urine or proof of pregnancy via ultrasound.)
  • Pre-pregnancy overweight (pregravid BMI > = 27) or positive family history of type 2 diabetes or GDM in first-degree relatives or GDM in previous pregnancy or previous macrosomia (baby with birth weight > 4000 g) or advanced maternal age > = 40 years
  • Ability to understand and voluntarily sign an informed consent document prior to any study related procedures.

排除标准

  • Age < 18 years
  • Multiple pregnancy
  • Pre-pregnancy Diabetes mellitus
  • Intake of medication that interferes with glucose-metabolism, such as glucose lowering or increasing drugs at inclusion visit (e.g. Steroids, Antidiabetics, Insulin, Metformin)
  • Treatment with drugs with central nervous actions
  • Chronic alcohol disease and drug abuse
  • Pre-existing cardiac condition
  • Mental disorder
  • Weight loss >10% in the previous 6 months
  • GFR < 60 ml/min/1.73 m2
  • 2-fold increased transaminase levels in reference to the upper standard
  • Any other (clinical) condition that would endanger participant's safety or question scientific success according to a physician's opinion.

结局指标

主要结局

Glycaemic excursion during an oral glucose tolerance test

时间窗: gestational week (GW) 24 - 28

The effect of a diet modification on glucose levels and postprandial glycemic excursions (AUC) during a 75g oral glucose tolerance test (OGTT) will be measured.

次要结局

  • Maternal weight gain during pregnancy(Gestational week 14,20, 28, 34)
  • Fetal brain activity(Gestational week 28)
  • Fetal heart rate variability(Gestational week 28)
  • Offsprings body weight(Delivery)
  • Offsprings body length(Delivery)
  • Way of delivery(Delivery)
  • Maternal insulin secretion(gestational week (GW) 24 - 28 and 6-12 weeks postpartum)
  • Offsprings head circumference(Delivery)
  • Glucose variability(Gestational week 14,20, 28, 34 and one week postpartum)
  • Maternal insulin sensitivity(gestational week (GW) 24 - 28 and 6-12 weeks postpartum)
  • Offsprings APGAR Score(Delivery)
  • Time of delivery(Delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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