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临床试验 NCT04562454 针对糖尿病目前状态未知。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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北京协和医学院An Exploratory Study on the Application of Continuous Glucose Monitoring System in the Measurement of Individual Glycemic Index After Eating Different Diets IV期 120 饮食
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临床试验NCT04562454旨在研究其他，主要针对糖尿病。这是一项IV期 干预性研究试验，目前试验状态为状态未知。试验始于2020年10月1日，计划招募120名患者。该研究由北京协和医学院主导，预计于2021年10月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2020年9月24日。
简要概括
The glycemic index (GI) is used to evaluate the level of elevated blood sugar immediately after carbohydrate intake and is a classified indicator of the glycemic potential of carbohydrate-containing test foods relative to reference foods. At present, more and more clinical studies have proved that a low-GI diet is beneficial to health, and can improve blood glucose control, weight and blood lipid levels in patients w...显示更多
详细描述
In this study, subjects with diabetes or impaired glucose tolerance were given continuous glucose monitoring (CGM) for 3 consecutive days, given a standard meal containing 50g carbohydrates and foods to be tested for GI. The purpose of this study was to explore the fluctuation of blood glucose, the time and range of blood glucose peak after eating different diets, and to guide the individual dietary choices of the su...显示更多
官方标题
An Exploratory Study on the Application of Continuous Glucose Monitoring System in the Measurement of Individual Glycemic Index After Eating Different Diets
疾病
糖尿病其他研究标识符
- 20200920-JS-2450
NCT编号
实际开始日期
2020-10-01
最近更新发布
2020-09-24
预计完成日期
2021-10-01
计划入组人数
120
研究类型
干预性研究
试验分期 (阶段)
IV期
试验状态
状态未知
主要目的
其他
分配方式
非随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Normal group Specific diet with CGM for 5days | Specific diet use a specific diet in different days with CGM to konw GI of different food in diabetes |
实验性T1DM group Specific diet with CGM for 5days | Specific diet use a specific diet in different days with CGM to konw GI of different food in diabetes |
实验性T2DM group Specific diet with CGM for 5days | Specific diet use a specific diet in different days with CGM to konw GI of different food in diabetes |
实验性other type of diabetes group Specific diet with CGM for 5days | Specific diet use a specific diet in different days with CGM to konw GI of different food in diabetes |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
fluctuation of blood glucose after eating different food | use the CGM to get the area under the curve of blood glucose of different food | baseline |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
- the experimental group: patients with diabetes or impaired glucose tolerance diagnosed clinically according to the World Health Organization's (WHO) diagnostic criteria of diabetes in 1999; the control group: according to the participants of the experimental group, matched the people with normal glucose metabolism in sex, age and region.
- Age: 18-80 years old; 3) patients or family members who can understand the research plan and are willing to participate in this study and sign a written informed consent form and questionnaire
- severe acute complications of diabetes (diabetic ketoacidosis, hyperglycemia and hyperosmotic state, diabetic lactic acidosis) in the past 6 months;
- serious chronic complications of diabetes, such as peripheral vascular disease leading to amputation or chronic foot ulcers, end-stage renal disease, etc., the researchers do not think it is suitable to participate in this study.；
- patients with two or more episodes of severe hypoglycemia in the past year (such as disturbance of consciousness caused by hypoglycemia, coma, etc.), or severe unconscious hypoglycemia;
- patients with severe impairment or circulatory disturbance of cardiac function (NYHA grade III or above), liver function (ALT, AST or TBil above the upper limit of the normal value), renal function (serum creatinine above the upper limit of the normal value) or circulatory disturbance.；
- patients with mental illness, confusion and inability to take care of themselves;
- patients with gastrointestinal diseases;
- patients or their families cannot understand the conditions and objectives of this study
北京协和医学院482 个活跃的临床试验可供探索研究中心联系人
联系人: Weigang Zhao, MD, +86 69151876, [email protected]
联系人: Shuoning Song, 15117977900, [email protected]
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