Improved Maternal and Fetal Outcomes Associated With Inositol Dietary Supplementation in Women With Early Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Insulin therapy in early diagnosis of GDM
研究概览
简要总结
Objective: Insulin resistance during normal pregnancy and in gestational diabetes mellitus (GDM) are unknown. New criteria are based on fasting glucose levels since the beginning of pregnancy. Inositol, a putative second messenger of insulin, correlates with the degree of insulin resistance. Dietary supplementation of inositol improves insulin resistance in patients with GDM.
详细描述
Methods: A randomized double-blind study was carried out in women with GDM. Patients were randomly exposed to inositol and placebo. Increase of BMI, blood glucose at 75 grams oral glucose tolerance test (OGTT), fetal and neonatal adverse outcome, and insulin treatment were correlated to inositol exposure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •singleton pregnant women
- •random fasting glucose above 92 mg%
排除标准
- •random fasting glucose above 126 mg%
结局指标
主要结局
Insulin therapy in early diagnosis of GDM
时间窗: 6 months
Inositol supplementation and diet with/without insulin therapy in early GDM
altered OGTT
时间窗: 6 months
OGTT altered at 24-28 wks in inositol and control group
次要结局
- delivery and neonatal outcomes(6 months)
研究者
Claudio Celentano
MD
G. d'Annunzio University