Trimester Sequential Estimation of Serum Zonulin Overrides Glucose Homeostasis Biomarkers for Prediction of Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Estimation of Gestational DM
研究概览
简要总结
Gestational diabetes mellitus (GDM) is the development of glucose intolerance (GI) during pregnancy in a previously normoglycemic (NG) woman and associated with insulin resistance (IR). GDM is the most prevalent metabolic disorder during pregnancy and became a major public health problem for being usually diagnosed and detected after 24 gestational weeks (GW), while its complications can occur much earlier and this may explain its burden on maternal and fetal welfare. Human zonulin is a surrogate marker of intestinal permeability and can be utilized as biomarker for intestinal barrier function. Zonulin-mediated increase in intestinal permeability plays a role in the pathogenesis of insulin resistance, obesity, DM and metabolic syndrome. The increasing global prevalence of GDM with its associated risk of poor pregnancy and long-term risks for the mother and the offspring may lead to the production of new generation of diabetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant Women with singleton fetus
排除标准
- •Women with morbid obesity with body mass index ≥35 kg/m2;
- •Had manifest DM, irrespective of being controlled or not;
- •Bowel-related disorders;
- •Autoimmune disorders;
- •History of previous GDM.
结局指标
主要结局
Estimation of Gestational DM
时间窗: 8 months
Relation between Serum Zonulin levels and Gestational Diabetes Mellitus
次要结局
未报告次要终点
研究者
Ahmed K Zaineldin
Lecturer of Obstetrics & Gynecology, Faculty of Medicine
Benha University
