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临床试验/NCT00911404
NCT00911404已完成不适用

Comparison of Two Different Diets Containing Different Proportions of Carbohydrates in the Treatment of Gestational Diabetes Mellitus: A Randomized Clinical Trial

Hospital Arnau de Vilanova2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2009年1月1日最近更新:
适应症

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

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

发起方
Hospital Arnau de Vilanova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marta Hernández García

MD

Hospital Arnau de Vilanova

研究点 (2)

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