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临床试验/NCT00860613
NCT00860613已完成不适用

Medical Nutrition Therapy Program for Pregnant Women With Diabetes: Evaluation of Two Different Dietary Strategies on Metabolic Control, Maternal and Fetal Nutritional Status and Cost Effectiveness.

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes2 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2004年2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
162
试验地点
2
主要终点
metabolic control

研究概览

简要总结

No dietary strategies have been designed and proved for Mexican pregnant women with diabetes. This is a randomized clinical trial of pregnant women with pregestational type 2 diabetes and gestational diabetes that were followed every two weeks until labor to assess the impact of the MNT program on metabolic control, maternal and fetal nutritional status and cost effectiveness. Participants were randomly assigned to one of three medical nutrition therapy (MNT) groups: the MNT 1 group (n=38) received usual medical treatment, counseling from a nutritionist and diabetes educator, using carbohydrate counting (40-45% of carbohydrates)with an intensive educational component; MNT2 group (n=50) had the same treatment, but included only low-moderate glycemic index foods; and NO-MNT group (n=45) received the current hospital treatment. All women will receive a glucose meter so they do self glucose monitoring (pre and postprandial) 2 times a weeks 6 times a day. Weight gain, dietary consumption and glucose concentrations will be evaluated every two weeks. Fetal outcomes (weight, length and presence of complications)will be measured at labor.

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

  • pregnant women with gestational diabetes (Freinkle´s classification: type A2 and B1) or pregestational type 2 diabetes.
  • less than 30 weeks of gestation
  • women who plan to attend their pregnancy at the institution (INPerIER)

排除标准

  • women with type 1 pregestational diabetes or gestational diabetes type A
  • women with multiple pregnancies
  • women with renal or hepatic disease
  • women who could not follow the dietary recommendations within the study

结局指标

主要结局

metabolic control

时间窗: every two weeks

次要结局

  • maternal nutritional status(every two weeks)
  • fetal nutritional status(at labor)
  • cost effectiveness(3 years)

研究者

发起方
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
申办方类型
Other Gov

研究点 (2)

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