NCT00314717已完成2 期
The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Women With Gestational Hyperglycemia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Fasting serum glucose
研究概览
简要总结
The purpose of the study is to see if a low glycemic index diet will reduce blood sugar levels in pregnant women with high blood sugar levels.
详细描述
Women with gestational hyperglycemia, including women with gestational diabetes and impaired glucose tolerance of pregnancy, consuming a low glycemic index (GI) diet will experience better blood glucose control thereby decreasing the risk associated complication(s).
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
- None
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
- •women with gestational hyperglycemia
- •age between 18 and 45 inclusive
- •willing and able to comply with protocol
排除标准
- •<18 or >45 years of age
- •other chronic or acute illness which affects carbohydrate metabolism
- •known multiple pregnancy
- •>34 weeks gestation
- •language barrier (no translator available)
结局指标
主要结局
Fasting serum glucose
时间窗: Baseline and 4 weeks
A1c
时间窗: Baseline and 4 weeks
Self-blood-glucose-monitoring results
时间窗: daily until delivery
次要结局
- maternal weight gain throughout pregnancy(weekly)
- number of individuals who receive insulin treatment while participating in the study(duration of pregnancy)
- latency to insulin requirement/ gestational age when prescribed insulin(duration of pregnancy)
- dosage and frequency of insulin(duration of pregnancy)
- ultrasound measurements (if available)(according to clinical practice)
- fasting lipids(Baseline and 4 weeks)
- fasting c-reactive protein(Baseline and 4 weeks)
- infant birth weight(at birth)
- infant blood glucose(at birth)
- infant plasma calcium(at birth)
- infant bilirubin at birth obtained via heel prick(at birth)
- birth complications(at birth)
- perceptions of educational materials
- perceptions of diet treatments
研究者
研究点 (1)
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