Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 10
- 主要终点
- Standard deviation of glycaemia
研究概览
简要总结
The aim of the GLORIA study is to determine whether an altered glucose metabolism (with more hypoglycaemia and glycaemic variability) and altered metabolomics during pregnancy after bariatric surgery contribute to the increased risk for adverse pregnancy outcomes such as small-for-gestational age infants. In addition, the investigators also aim to evaluate whether continuous glucose monitoring (CGM) can be used to diagnose gestational diabetes (GDM).
详细描述
The GLORIA study is a Belgian multicenter prospective cohort study. The investigators aim to recruit 95 pregnant women after bariatric surgery (gastric bypass or sleeve gastrectomy) and as a control group, an age and BMI-matched cohort of 95 pregnant women without bariatric surgery. Participants will be recruited before 12 weeks of pregnancy. To evaluate glucose homeostasis, a masked CGM will be used for 10 days during each trimester in pregnancy and at the time of screening for GDM (at 24-28 weeks). The primary outcome is the mean glycaemia levels and glycaemic variability (SD) measured by CGM in pregnancy. At the different time points, anthropometric measurements (including body composition), food diary, questionnaires and micronutrients will be evaluated. In addition, in collaboration with the lab of Cristina Legido Quigle from the Steno Diabetes Center in Copenhagen, metabolomics will be analyzed. Women with a history of bariatric surgery will receive screening for GDM between 24-28 weeks of pregnancy by performing self- monitoring of blood glucose (SMBG) with a glucometer during one week. In addition to SMBG, women will receive a masked CGM during one week.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-45 years and with a singleton pregnancy with ultrasound-confirmed gestational age up to 11 weeks and 6 days
- •for the group with bariatric surgery: history of gastric bypass (RYBG) or sleeve gastrectomy (SG)
- •Participants need to speak and understand Flemish, French or English and have e-mail access.
排除标准
- •multiple pregnancy
- •pregnancy ≥12 weeks
- •other types of bariatric surgery than RYBG or SG
- •known pregestational diabetes
- •a physical or psychological disease likely to interfere with the conduct of the study
- •medications known to interfere with glucose metabolism.
研究组 & 干预措施
pregnant group with bariatric surgery
pregnant women with a history of gastric bypass or sleeve gastrectomy
干预措施: CGM (Diagnostic Test)
matched pregnant group without history of bariatric surgery
age-and BMI matched pregnant women without history of bariatric surgery
干预措施: CGM (Diagnostic Test)
结局指标
主要结局
Standard deviation of glycaemia
时间窗: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
SD measured by CGM
mean glycaemia
时间窗: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy
mean glycaemia measured by CGM
次要结局
- glycaemic variability measured by mean amplitude of glucose excursions (MAGE)(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)
- time <50mg/dl(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)
- time > 120mg/dl(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)
- preterm delivery(delivery)
- large-for-gestational age infant(delivery)
- small-for-gestational infant(delivery)
- body fat percentage women(between 6-12 weeks of pregnancy)
- body fat percentage newborns(within 3 days after birth)
- time <54mg/dl(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)
- glycaemic variability measured by coefficient of variation (CV)(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)
- time <70mg/dl(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)
- low blood glucose index (LBGI)(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)
- cesarean sections(delivery)
- gestational hypertension(delivery)
- pre-eclampsia(delivery)
- symptoms of depression(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)
- index of quality of life(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)
- time <63mg/dl(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)
- time > 140mg/dl(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)
- time > 180mg/dl(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)
- gestational weight gain(at end of pregnancy)
- neonatal hypoglycaemia(delivery)
- prevalence of gestational diabetes(24-28 weeks of pregnancy)
- macronutrient intake baseline(between 6-12 weeks of pregnancy)
- Neonatal intensive care admission (NICU)(delivery)
- micronutrient deficiencies(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy and 30-34 weeks of pregnancy)
- fetal abdominal circumference (AC)(at 12, 20, 30 and 34 weeks of gestation)
- fetal abdominal subcutaneous fat thickness (ASCF)(at 12, 20, 30 and 34 weeks of gestation)
- placental function(at 12, 20, 30 and 34 weeks of gestation)
- macronutrient intake in pregnancy(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)
- symptoms of anxiety(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)
- physical activity(between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy)