Efficacy of Metformin Treatment in Not Controlled With Diet Gestational Diabetes Versus Use of Insulin Therapy
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 主要终点
- Metformin benefits
研究概览
简要总结
Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.
详细描述
Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.
The objectives are: Demonstrate that treatment with metformin in women with GD (not controlled with diet) can get no lower obstetric and perinatal outcomes than those with standard treatment with insulin.
Demonstrate that glycemic control with metformin in properly selected women, can be equivalent to that obtained with insulin.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-45 years old.
- •Diagnosis of GD, with fasting glucose <120 mg / dL.
- •not controlled by diet: fasting capillary blood glucose> 95 mg / dl in at least 2-3 times or 1 hour postprandial >140 mg / dl on, at least 2-3 times a week.
- •2nd or 3rd trimesters of pregnancy.
- •Able to give informed consent.
排除标准
- •Psychopathological situations that do not guarantee proper adhesion to follow up
- •1st trimester of pregnancy
- •gastrointestinal diseases that may cause poorer tolerance or increased symptoms with metformin.
- •Patients who can not attend the scheduled consultation.
- •Language barrier limiting for understanding treatment settings
- •Twin pregnancy.
研究组 & 干预措施
Metformin
850-2550 mg every 24h.
干预措施: Metformin (Drug)
Metformin
850-2550 mg every 24h.
干预措施: Insulin Detemir (Drug)
Insulin Detemir
Individual doses according to glycemic controls.
干预措施: Metformin (Drug)
Insulin Detemir
Individual doses according to glycemic controls.
干预措施: Insulin Detemir (Drug)
结局指标
主要结局
Metformin benefits
时间窗: 50 weeks
Change of Weigth
Good glycemic control
时间窗: 50 weeks
Change of glycemic levels
Baby wellness
时间窗: Delivery
Weight
次要结局
- Adverse event profile(50 weeks)
- Fructosamine as a marker of insulinization(50 weeks)
- Satisfaction with the treatment(50 weeks)
- IL-6 profile(50 weeks)
- IL-10 profile and oxidativge stress as well as in lipid profile(50 weeks)
- Leptin profile(50 weeks)
- Ladiponectin and oxidativge stress as well as in lipid profile(50 weeks)
- LPS profile(50 weeks)
- LBP profile and oxidativge stress as well as in lipid profile(50 weeks)