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临床试验/NCT00681460
NCT00681460已完成不适用

Effects of Insulin and/or Metformin Treatment on Perinatal Outcome and Metabolic Parameters in Women With Gestational Diabetes Mellitus: Prospective Randomized Trial.

K. Marcinkowski University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
1
主要终点
newborn weight

研究概览

简要总结

Gestational diabetes (GDM) is a condition that manifests as high blood sugar levels (hyperglycemia) during pregnancy in previously healthy women. It develops as a result of increased maternal body's resistance to insulin - a major hormone that allows for utilisation of glucose (sugar taken in with food) within cells. It was found out that GDM occurs more frequently in overweight women but also in women with a history of certain conditions such as polycystic ovary syndrome (PCOS). Usually, GDM disappears after pregnancy is completed but it is associated with some serious hazards for women and her unborn child, if untreated properly. Diet is a first-choice treatment but sometimes insulin therapy must be initiated if keeping a diet alone is not enough to maintain blood sugar within recommended values. Insulin therapy is effective but it requires several injections during each day and insulin is a strong acting hypoglycemic agent that may induce rapid falls in blood sugar, also dangerous for mother and unborn child.

In the investigators study, the investigators would like to investigate if metformin that is a commonly used hypoglycemic drug can be effectively used for GDM treatment. Metformin has been used successfully for a long time to treat type 2 diabetes mellitus and PCOS and, according to current data, it is not dangerous neither for mother nor for baby when used during gestation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • diabetes diagnosed during pregnancy
  • single pregnancy
  • ineffective diet therapy

排除标准

  • pregestational diabetes
  • fetal malformation
  • multiple pregnancy
  • contraindications to metformin therapy (liver or kidney disease)

研究组 & 干预措施

1

Active Comparator

gestational diabetes, insulin therapy

干预措施: human recombined insulin (Drug)

2

Experimental

gestational diabetes, metformin therapy

干预措施: metformin (Drug)

结局指标

主要结局

newborn weight

时间窗: first hour of life

次要结局

  • parameters of metabolic control in mother and newborn, insulin resistance, inflammatory reaction, oxidative stress, fetal growth,(during pregnancy and up to twelve hours after delivery)

研究者

发起方
K. Marcinkowski University of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Agnieszka Zawiejska, MD, PhD

Department of Obstetrics and Women's Diseases, Senior Lecturer

K. Marcinkowski University of Medical Sciences

研究点 (1)

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