Effectiveness and Safety of Nutrition Product in Gestational Diabetes Mellitus Patients, Based on Continuous Glucose Monitoring, a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of other product-related/possibly related adverse events or serious adverse events
研究概览
简要总结
A prospective, multicenter, randomized controlled trial including about 60 Gestational Diabetes Mellitus patients (GDM) in Beijing will be included to evaluate the effectiveness and safety of nutrition product (SANZ®KINGWILL) in GDM patients, based on Continuous Glucose Monitoring (San MediTech CGM-303).
详细描述
This study will recruit pregnant women who were diagnosed as GDM by 75g Oral glucose tolerance test (OGTT) in 2nd trimester and followed up for 1month. A total of 60 GDM patients were expected to be enrolled. Using the double-blind method, they were randomly divided into two groups: experimental group and control group. Both of the two groups were provided medical nutrition treatment by nutritionist after GDM was diagnosed and CGM equipment (San MediTech CGM-303) was worn. Blood and urine samples were collected. At the following two days, oatmeal (SHIZHUANG) was used as extra meal at 10:00am and 15:00pm in both groups. In the next 4 weeks experimental group was provided with the domestic nutrition product (SANZ®KINGWILL), while existing products (GLUCERNA SR®) for control group as their extra meals at 10:00am and 15:00pm. In the last day, CGM equipment (San MediTech CGM-303) was removed and blood and urine samples were collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 22 to 40 years old
- •Diagnosed as gestational diabetes mellitus
- •Signed informed consent
排除标准
- •GDM patient who is no longer suitable to continue pregnancy.
- •Patients who use any hypoglycemic drugs or any type of similar products.
- •Patients who have diseases severely affected the nutrition product digestion and absorption.
- •Patients with severe heart, liver, kidney dysfunction, mental retardation, dyscrasia, etc.
- •Patients who cannot tolerate enteral nutrition.
- •Patients with other conditions which investigator believes they are not eligible for this study.
结局指标
主要结局
Number of other product-related/possibly related adverse events or serious adverse events
时间窗: 4 weeks
Number of other product-related/possibly related adverse events or serious adverse events
Glycated albumin level
时间窗: 4 weeks
Changes of Weight
时间窗: 4 weeks
Area under the blood glucose curve (AUC)
时间窗: 4 weeks
Area under the blood glucose curve (AUC) by CGM within 2 hours of using the nutrition product.
Blood glucose control outcome
时间窗: 4 weeks
Fasting blood glucose
次要结局
未报告次要终点