Gestational Diabetes Mellitus: Insulin or Oral Hypoglycemic Agents?
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
- 否
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
Rapid acting insulin and long acting insulin
干预措施: Insulin (Drug)
Oral Hypoglycemic Agents
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
Jean-Luc Ardilouze
Endocrinologist, researcher
Université de Sherbrooke
