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临床试验/NCT01215331
NCT01215331已完成3 期

Gestational Diabetes Mellitus: Insulin or Oral Hypoglycemic Agents?

Université de Sherbrooke1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
73
试验地点
1
主要终点
Glycemic control

研究概览

简要总结

Gestational diabetes mellitus takes place in 2 steps. First, it is the consequence of insulin resistance due to the modifications of the pregnancy hormonal environment, and second, of the deficiency of the beta cells of the pancreas to respond by a sufficient insulin secretion. This physiopathology is closely connected to the one of type 2 diabetes. Insulin, indeed, can remedy these 2 etiologies, but it is logical to think about using oral hypoglycemic agents which have been created to treat them: they are a natural choice because they improve insulin sensitivity (metformin, a biguanide) or insulin secretion (glyburide, a sulfonylurea). It also seems natural to use them in combination, glyburide being added to metformin if needed.

OUR GENERAL RESEARCH HYPOTHESIS IS THAT: in pregnant women with gestational diabetes mellitus, using both oral hypoglycemic agents (glyburide added to metformin if needed) allows a glycemic control comparable to the one obtained with insulin, but with a better acceptability from women and a better health status, diabetes treatment satisfaction and well-being and a reduced postnatal depression.

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

  • age ≥ 18 yrs,
  • with gestational diabetes at 24-28 weeks (Canadian Diabetes Association (CDA) criteria),
  • who need a pharmacological treatment following the failure of the diet and exercise,
  • to understand and read French or English.

排除标准

  • known type 1 or type 2 diabetes,
  • treatment interfering with glucose metabolism,
  • allergies to one of the components of the treatment,
  • hepatic or hematologic diseases.

研究组 & 干预措施

Insulin

Active Comparator

Rapid acting insulin and long acting insulin

干预措施: Insulin (Drug)

Oral Hypoglycemic Agents

Experimental

Metformin + glyburide + insulin if needed

干预措施: Metformin, glyburide and insulin (Drug)

结局指标

主要结局

Glycemic control

时间窗: 36 and 37th week of gestation

Mean of the capillary glycemic control at 36 and 37th week of gestation.

次要结局

  • Acceptability of the treatment(8-12 weeks after delivery)

研究者

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

Jean-Luc Ardilouze

Endocrinologist, researcher

Université de Sherbrooke

研究点 (1)

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