IMAGE (Metabolic Risk During Gestation) : Prospective Study of Women With Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 14
- 主要终点
- Metabolic index value
研究概览
简要总结
Gestational diabetes (GDM) is defined by abnormal glucose tolerance during gestation. This complication occurs in 4-10% and is associated with fetal complications and macrosomia. In addition, women with GDM have an increased risk to develop type 2 diabetes after delivery. Despite recommendations, it is difficult to follow-up all women with GDM during the postpartum period due to high numbers of subjects that exceed usual healthcare resources. It is therefore necessary to focus clinical attention toward women at high risk of type 2 diabetes in order to set adequate preventive strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 否
入选标准
- •Women aged over 18years old
- •Women with the criteria of GDM during pregnancy at 21-35 weeks of gestation (one situation):
- •After a 75g Oral Glucose Tolerance Test (OGTT - WHO criteria) with blood glucose (BG) values at T60≥180mg/dl and/or T120≥153mg/dl
- •An O. Sullivan test following a 100g oral glucose load with at least two pathological values (T60 ≥ 180mg/dl and/or T120 ≥ 155mg/dl and/or T180 ≥ 140mg/dl)
- •With a fasting BG value ≥92mg/dl
- •Women with signed informed consent
排除标准
- •Women aged less than 18years old
- •Women with pregestational type 2 diabetes
- •Women without signed informed consent
- •Women who does not read and/or understand french language
- •Women not affiliated to the health care system
- •Women with recent infection (<1month) and/or on steroids or anti-inflammatory drugs.
- •Women with chronic diseases
- •Women with a disable state
- •Women with normal glucose tolerance
- •Women already incorporated in another clinical study that could interfere with the present study
结局指标
主要结局
Metabolic index value
时间窗: 3 months after delivery (+/- 15 days)
The primary objective relies on Receiver Operating Characteristic (ROC) curves of metabolic index values using peripheral markers during gestation : C-Reactive Protein ultrasensitive (CRPus), malonaldehyde (MDA) and adiponectin (index = (CRP + MDA)/adiponectin) to detect an abnormal glucose tolerance at 3 months (+/- 15 days) after delivery (M3) during a 75g oral glucose tolerance test (T0\>110mg/dl and/or T120 \>145mg/dl). The rationale for the index relies on lower adiponectin values high CRPus levels and MDA values during insulin resistance chronic inflammatory status and oxidative stress.
次要结局
- Prevalence of abnormal glucose tolerance in women with GDM(3 months (+/- 15 days) following delivery)