Effects of Selenium Nutritional Supplement of Glucose, Nutritional Status, and Clinical Outcome Among Type 2 Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Drugs of reduce glucose or stop using the antidiabetics.
研究概览
简要总结
According to the prevalence of non-communicable chronic diseases and aging population characteristics, this study is exploring the coexist effects combined with various dimensions: nutritional functions, metabolic homeostasis, inflammation and immunity by the selenium supplementation among type 2 diabetes, which based on insulin resistance, beta-cell function disorders, and body metabolic homeostasis disorders of the mechanism of type 2 diabetes by lifecycle so that could provide with a totally new and safe nutritional method for type 2 diabetes prevention and diagnosis.
详细描述
This study will last 16 weeks. There will be 300 subjects enrolled by random lottery methods in this randomized double-blind placebo-controlled clinical study by control group, low dose group and high dose group. During the study processing, follow-up visit by call, questionnaires, blood and stool collection, and functional testing will appear. Statistical analysis would be analysis according to the actual outcome of study.
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
- Double (Participant, Investigator)
盲法说明
Double(Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •.Range of age:18~75, both males and females are permitted.
- •.As to the diagnosis criteria of type 2 diabetes:glucose higher than 13.9mmol/L, drastic fluctuation (upper that 2mmol/L) , severe complication, or coupled with other severe chronic diseases( including overweight, obesity, lipid disorders, hypertension, ASCVD,HF, CKD, never appears.
- •.Treatments: exercise lifestyle intervention plus oral antidiabetic drugs, such as: single drug(metformin) plus exercise lifestyle intervention, coupled drugs(metformin+acarbose) plus exercise lifestyle intervention, both of them never use insulin.
- •.Signed with the informed consent, and enrolled in this study in volunteer.
排除标准
- •.Physical fitness must attach to the goal of Par-Q questionnaire and 6 minutes running test. Besides, individuals whose glucose has drastic fluctuation should be excluded.
- •.Coexist with severe complication and being in the urgent status during the progress of diseases, such as acute complication and infection, hyperplasia retinopathy, severe neuropathy, diabetic foot ulcer, coupled with cardiac insufficiency, diabetic massive proteinuria, recent myocardial infarction, cerebral infarction or cerebral hemorrhage, blood glucose higher than 13.9mmol/L or less than 3.9 mmol/L.
- •Patients suffering various serious chronic diseases, including unstable angina, uncontrolled arrhythmia, severe valvular heart disease or cardiomyopathy;
- •Uncontrolled hypertension or blood pressure over 180/110mmHg;
- •.In the period of trying to conceive or pregnant or lactating.
- •.Patients who have had cerebral infarction, stroke, history of major surgery, acute attack of infectious diseases or obvious sequelae of infection;
- •.Sever psychology disorders and mental diseases.
- •The mass of selenium in body is over the upper limitation, or selenium yeast tablets, as a nutrition supplemented, subjects should not allergic to yeast, and cannot be included. Besides, patients who have recently taken selenium-rich health food or medicine;
- •Severe malnutrition and overnutrition;
- •Significant mobility and cognitive impairment;
- •.Sickle cell disease, hemodialysis, recent blood loss or blood transfusion, etc.
结局指标
主要结局
Drugs of reduce glucose or stop using the antidiabetics.
时间窗: 12 weeks
Dose or types of antidiabetics drugs would reduce.
次要结局
- GPX activity(12 weeks)
- Situation of glucose(12 weeks)
- Status of immunity(12 weeks)
- Nutrition status of selenium(12 weeks)
研究者
Yu Kang, MD
Professor
Peking Union Medical College Hospital