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临床试验/NCT01287299
NCT01287299已完成不适用

Dietary Glycemic Load & Metabolism in Obese Pregnant Women

UCSF Benioff Children's Hospital Oakland2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2005年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
maternal body fat gain

研究概览

简要总结

The purpose of the study is to determine if a low glycemic load diet reduces the gain of body fat and insulin resistance during the last half of pregnancy in obese women.

详细描述

Obese women will be recruited to participate in the study between 14-18 weeks gestation. After determining usual dietary intakes, visceral fat thickness, and the metabolic response to a 100g oral glucose tolerance test (OGTT) at 20 weeks gestation, 45 of the women will be randomly assigned to a low glycemic load (GL) diet and 65 women to a regular low fat diet (current standard care). They will follow their assigned diet for the last 20 weeks of gestation. A dietitian will advise the women and will monitor them throughout the study. At 28 and 34 weeks gestation, the women will come to the General Clinical Research Center (GCRC) at San Francisco General Hospital in the fasting state and the hormonal and metabolic response will be measured to another 100g oral glucose tolerance test (OGTT), and total body fat will be measured. Additional measurements include: 1) longitudinal measurements of maternal visceral fat thickness and fetal size and adiposity at 20 and 34 weeks gestation by ultrasound, 2) collection of cord blood and placental tissue, and 3) measurement of neonatal body composition by dual-energy x-ray absorptiometry and anthropometry at 2-3 weeks of age. Birth outcome data for mother and infant will be collected. To determine the metabolic response to the study diet, 25 women from each of the two diet groups will be assigned to a metabolic subsample for measuring rates of hepatic glucose production and lipolysis at 34 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • >35% body fat
  • 18 to 40 years of age
  • speak English or Spanish

排除标准

  • have diabetes prior to pregnancy
  • diagnosed with GDM in current pregnancy
  • abuse alcohol or drugs
  • have a metabolic disease

结局指标

主要结局

maternal body fat gain

时间窗: 20-34 weeks gestation

Changes in total body fat as measured by air displacement between 20 to 34 weeks gestation

次要结局

  • Insulin Resistance(20-34 weeks gestation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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