The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Pregnant Women at Risk for Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Serum glucose concentration 1hr after glucose challenge test
研究概览
简要总结
Gestational diabetes mellitus (GDM) is a condition in which high blood sugar levels occur during pregnancy. GDM increases the risk of medical complications during pregnancy which may harm the mother and her baby. Since treating GDM to reduce blood sugar reduces the risk of harm, all pregnant women are screened for GDM using a glucose challenge test (GCT). We think that a diet containing low glycemic index foods could help keep blood sugar levels normal during pregnancy and therefore prevent GDM. Thus, the purpose of this study is to see if a diet containing low glycemic index foods will reduced blood sugar after the GCT and reduce the prevalence of GDM in women at high risk for the development of GDM.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Attending Mt. Sinai Maternal Fetal Medicine Unit
- •Any ONE of: body mass index >=25 kg/m^2
- •OR age >=35 years
- •OR high risk ethnicity (Asian, South Asian, Hispanic, African, Aboriginal)
排除标准
- •Have pre-existing diabetes (type 1 or type 2) before becoming pregnant
- •Acute or chronic illness which may affect carbohydrate metabolism
- •Language/literacy barriers which cannot be overcome via available resources
- •>16 weeks gestation
结局指标
主要结局
Serum glucose concentration 1hr after glucose challenge test
时间窗: 26 weeks gestation
次要结局
- Mode of delivery(At time of birth of baby)
- GCT outcome(26 weeks gestation)
- GDM outcome(26 weeks gestation)
- Maternal weight(At EACH of the following times: 12, 16, 20, 24, 28, 32, 36 and 40 weeks gestation)
- Presence of birth trauma(At time of birth of baby)
- Weight of baby(At time of birth of baby)
- Presence of macrosomia(At time of birth of baby)
- presence of large for gestational age baby(At time of birth of baby)
- Presence of small for gestational age baby(At time of birth of baby)
- food frequency questionnaire(at 12 weeks and 26 weeks gestation)
- Acceptability of study foods(26 weeks gestation)
研究者
Thomas Wolever
Professor
University of Toronto