Comparison of Two Different Diets Containing Different Proportions of Carbohydrates in the Treatment of Gestational Diabetes Mellitus: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Need of insulin treatment for GDM
研究概览
简要总结
There is evidence that controlling total amount of carbohydrates is a strategy for controlling glucose levels in diabetes mellitus. There is not major evidence that any given macronutrient percentage may be recommended to treat a woman with Gestational Diabetes Mellitus (GDM). In the investigators' country, insulin is the second-line treatment once medical nutrition therapy (MNT) has failed to control glucose levels during pregnancy. Insulin treatment is more expensive and not as well accepted as MNT. The investigators have designed a randomized-controlled trial to assess whether a diet with 40% total calories from carbohydrates may reduce the need of insulin treatment in women with gestational diabetes, without having unfavourable pregnancy outcomes, in comparison with a diet with 55% total calories from carbohydrates.
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
- Single (Participant)
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
- •Gestational diabetes mellitus
- •Single pregnancy
排除标准
- •Multiple pregnancy
- •High risk pregnancy (any other concomitant illness, excluding hypertension and obesity)
- •Low ability to understand and follow a diet
- •Need to use insulin different from regular insulin
结局指标
主要结局
Need of insulin treatment for GDM
时间窗: Day of delivery
次要结局
- Maternal morbidity(Day of delivery)
- Maternal ketonemia and/or ketonuria(Day of delivery)
- Time from GDM diagnosis free of insulin treatment(Day of delivery)
- Fetal morbidity(1 month after delivery)
研究者
Marta Hernández García
MD
Hospital Arnau de Vilanova
