Research on Comparison Between Rice-richen Meal and Wheaten-richen Meal on Glucose Control Status Among Chinese Women With GDM
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- between-group difference in glucose control
研究概览
简要总结
Since the prevalence of gestational diabetes melitus (GDM) increased by ..., as an important part of medical treatment, nutrition therapy is highly required to help patients achieve normoglycemia. Carbohydrate intake is the primary nutrient affecting postprandial glucose levels,therefore the total amount and type of carbohydrate should be manipulated to blunt postprandial hyperglycemia. However,the type of carbohydrate has not yet been established. Rice and wheaten food have similar Glycemic Index (GI),but some researches found the glucose response to them is different. A case-control study is designed to compare the glucose control status between rice-richen meal and wheaten-richen meal, and all other macronutrients and micronutrients are all calculated and same between two groups, which may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women who undergo health examination in obstetric department in Peking Union Medical College Hospital.
- •20-45 years old.
- •Pregnant women who are diagnosed with GDM according to the American College of Obstetricians and Gynecologists (ACOG) diagnostic criteria during 24-28 weeks.
- •Be ability to use mobile medical equipment, conditional follow-up of the mother and child.
- •Voluntary participation in this study.
排除标准
- •Multiple pregnancy.
- •Merger of serious diseases (such as hypertension, respiratory diseases, kidney disease, abnormal coagulation, immune system diseases, infectious diseases), history of adverse pregnancy (such as spontaneous abortion, habitual abortion), and history of GDM.
- •Pregnant women with known diabetes before pregnancy, those requiring insulin or hormone therapy.
- •Pregnant women who are deemed inappropriate to participate in this clinical study by her physician.
研究组 & 干预措施
rice-richen meal
All participants included in the study will be randomized assigned into one of two groups in parallel, the rice-richen meal group and wheaten-richen meal group. The intervention of group one is that participants will be provided with rice-richen meal, meaning most of the calculated carbohydrates are from rice.
干预措施: rice-richen meal (Other)
wheaten-richen meal
All participants included in the study will be randomized assigned into one of two groups in parallel, the rice-richen meal group and wheaten-richen meal group.The intervention of group two is that participants will be provided with wheaten-richen meal, meaning most of the calculated carbohydrates are from wheaten.
干预措施: wheaten-richen meal (Other)
结局指标
主要结局
between-group difference in glucose control
时间窗: 16 weeks
comparison of the percentage of desired glucose status between two groups
次要结局
- between-group difference in undesirable clinical outcome(20 weeks)
研究者
Liuyanping
Doctor
Peking Union Medical College Hospital