Effects of a Standardized Dietary Intake on Metabolic Outcomes in Obese Pregnant Women With Gestational Diabetes and on Offspring Body Composition
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l)
研究概览
简要总结
eMOM is a randomized, controlled trial to compare the effects of two different dietary interventions during pregnancy. The comparison is based on tissue glucose content (using continuous glucose monitoring system) in pregnant women and on neonate body composition. The recruited women (n=50) have early gestational diabetes mellitus (diagnosed before gestational weeks 13), are obese (BMI >30 kg/m²) and of Caucasian origin. Of the study diets, one is moderately carbohydrate restricted and the other one is high on plant-based protein with an emphasis on healthy Nordic foods. The study has three two-week study periods that are carried out on approximately gestational weeks 13-14 (period I), 24-25 (period II) and 34-35 (period III). Continuous glucose monitoring and other measurements (accelerometer, 3-day food record, gut microbiota, serum lipids, metabolomics, epigenetics etc.) are done during these study periods. At the beginning of the study, before study period I, the participants are randomized to either one of the intervention diets. The first study period consists of a crossover phase in which the participants receive three days' worth of food according to one of the intervention diets (according to the randomization) after which there is a three-day wash-out period. After the wash-out period, the participants receive three days' worth of food according to the other diet. After the first study period, a nutritionist advises the lastly followed intervention diet to the participant and the diet is followed until delivery. To ensure the diet is followed, the participant gets at least five personal counselling sessions, mobile reminders, recipes and food items. After delivery, the infant's body composition, epigenetic markers of cord blood and placenta, gut microbiome and urine metabolomics are measured.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Early gestational diabetes (pregnancy weeks 10-15)
- •BMI ≥ 30 kg/m2
- •Pregnancy confirmed with ultrasound screening
排除标准
- •Multiparous pregnancy
- •Food allergies or restrictions (other than lactose intolerance)
- •Mother's or father's ethnic background other than Caucasian
- •Type 1 or type 2 diabetes
- •Medication which affects glucose metabolism
- •Cholesterol medication
- •Drug or alcohol abuse
- •Psychiatric illness which affects participation in study
- •Factors hampering communication (e.g. lack of Finnish skills)
研究组 & 干预措施
Carbohydrate restricted diet
Dietary intervention: moderately carbohydrate restricted diet. Parallel phase starts after study period I and the diet is followed until labor.
干预措施: Carbohydrate restricted diet (Other)
Plant-protein based diet
Dietary intervention: plant-protein based diet, en emphasis on healthy Nordic foods. Parallel phase starts after study period I and the diet is followed until labor.
干预措施: Plant-protein based diet (Other)
结局指标
主要结局
Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l)
时间窗: Study period III: during a 14 day period within gestational weeks 33-36
Measured with FreeStyle®Libre, Continuous Glucose Monitoring system
Child: Neonatal body fat%
时间窗: one measure within 0-2 days after birth of the child
Neonatal body fat%; Measured with PEA POD Cosmed® Infant Body Composition Assessment system
次要结局
- Mother: Glycaemic variability in crossover phase(Study period I: during a 3 day intervention-diet period within gestational weeks 12-15)
- Mother: Glycaemic variability(Study period III: during a 14 day period within gestational weeks 33-36)
- Percentage of participants on GDM medication(Up to 42 gestational weeks)
- Mother: The percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l) in cross-over phase(Study period I: during a 3 day intervention-diet period within gestational weeks 12-15)
研究者
Saila Koivusalo
Principal Investigator
Helsinki University Central Hospital
