Exploration of the Lipid Metabolism During the Diabetic Pregnancies and Research for New Biological Predictors to Nutritional Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- fetal weight corrected by gestational age
研究概览
简要总结
Justification:
Intrauterine exposure to type 1 or type 2 diabetes increase the risk of macrosomia (35 % to 50 % versus 10 % in general population) despite a good glycemic control. The consequences are : shoulder's dystocia, lung immaturity, caesarean section, neonatal hypoglycaemia and a high frequency of obesity and metabolic disorders in adults.
The mechanisms of macrosomia are unclear; chronic hyperglycemia and subsequent hyperinsulinaemia observed during the diabetic pregnancy might explain only partially the fetal weight. Considerable interest has been generated over the last decade on the lipids and fatty acids alterations in diabetes pregnancies. Change in lipoproteins metabolism have been described associated with macrosomia. Maternal nutrition before and during pregnancy plays an important role in fetal growth and subsequent development of an increased susceptibility to obesity and diabetes in later life.
Main objective:
Looking for an association between maternal and fetal blood lipid parameters and birth weight and body fat in a context of type 1 or type 2 diabetes.
Secondary objectives:
- Identify lipid markers associated with fetal macrosomia.
- Analyze the placenta by measuring the expression of genes implicated in the storage and the transfer of fatty acids.
- Analyze and compare the expression level of placental genes subjected to parental imprinting and validated in animal models.
详细描述
Plan of study:
Longitudinal study on 3 groups: 70 type 1 diabetic women, 70 type 2 diabetic women and 70 women with normal glucose tolerance during pregnancy. Recruitment in the department of Diabetology and Obstetrics of CHRU of Amiens and Lille.
Nutritional survey and sampling of blood in the 1st, 2nd and 3rd trimester of pregnancy and at 6 weeks post partum.
Collection of cord blood and placental tissues. Histological and molecular analysis of placenta will be realized both in the departments of Anatomopathology of Lille and Amiens and in Biochemistry Molecular Biology of CHRU of Lille.
Homocysteine and folate assays on cord blood will be centralized in Paris (Hospital St Louis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •pregnant women included before 16 amenorrhea weeks
排除标准
- •obesity (BMI > 40kg/m2)
- •subject became pregnant with medical infertility treatment
- •tobacco > 10
- •suspected abuse of alcohol
结局指标
主要结局
fetal weight corrected by gestational age
时间窗: just after delivery
次要结局
- cholesterol (total, HDL, LDL)(3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord)
- erythrocytary and plasmatic fatty acid distribution(3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord)
- triglycerides(3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord)
- Apolipoprotein A/B rate(3 measures during pregnancy and 1 at post partum, 1 measure at time of delivery from fetal cord)