Randomized Comparative Trial on the Efficacy of Behavioral Therapy, Exercise and Their Combination in Gestational Diabetes Mellitus (GDM).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Serum fasting glucose values.
研究概览
简要总结
The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.
详细描述
Women with gestational diabetes (GDM) are at increased risk of adverse pregnancy and neonatal outcomes. It is estimated that most women diagnosed with GDM can achieve targeted glycemic goals with nutrition therapy alone. A moderate exercise is recommended to lower serum glucose and to improve insulin sensitivity. Despite this, few reports examine the effect of exercise on glucose intolerance during pregnancy. Furthermore, no trial on the efficacy of behavioral treatment in women with GDM is available.
The purpose of the study is to test whether four lifestyle intervention programs (diet alone; diet and behavioral therapy, diet and exercise, diet and behavioral therapy and exercise), delivered to women with GDM during 24-26 weeks of gestational age will help women to improve their metabolic pattern, and decrease the incidence of adverse maternal and neonatal outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age between 24 and 26 weeks
- •Diagnosis of GDM at the 75g oral glucose tolerance test (OGTT)
- •Singleton pregnancy
排除标准
- •Body mass index > 40 or < 12kg/m2
- •Any known diseases (pre-existing diabetes mellitus, cardiovascular diseases, liver/kidney diseases, cancers, arterial hypertension)
- •Patients on any drugs
结局指标
主要结局
Serum fasting glucose values.
时间窗: Fasting glucose will be measured at recruitment (24 weeks of gestation) and at the end of follow-up (38 weeks of gestation)
To investigate changes from baseline in serum fasting glucose values in each arm with a 2x2 factorial design.
次要结局
- Serum fasting insulin values(At recruitment (at 24 weeks of gestation) and at the end of follow-up (38 weeks of gestation))
- The need for insulin therapy(At recruitment and at the end of follow-up (38 weeks))
- The number of Cesarean sections(From recruitment until the date of delivery, either natural or by Caesarean section, assessed up to 42 weeks)
- The mean birth-weight of newborns(From recruitment until the date of delivery, assessed up to 42 weeks)
研究者
Simona Bo
Principal Investigator, MD, Professor Assistant, Department of Internal Medicine
University of Turin, Italy