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临床试验/NCT06336512
NCT06336512已完成不适用

Trimester Sequential Estimation of Serum Zonulin Overrides Glucose Homeostasis Biomarkers for Prediction of Gestational Diabetes Mellitus

Benha University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年1月15日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed K Zaineldin

Lecturer of Obstetrics & Gynecology, Faculty of Medicine

Benha University

研究点 (2)

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