Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
300 participants
INTERVENTIONAL
2024-06-15
2025-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low dose selenium supplementation group+lifestyle intervention
Low dose selenium supplementation:50μg/d +lifestyle intervention
Selenium nutritional supplementation
Selenium yeast, as a safe from supplementation, could be a new nutritional intervention for lifecycle regulation of type 2 diabetes.
High dose selenium supplementation group+lifestyle intervention
High dose selenium supplementation :300μg/d+lifestyle intervention
Selenium nutritional supplementation
Selenium yeast, as a safe from supplementation, could be a new nutritional intervention for lifecycle regulation of type 2 diabetes.
Placebo control group+lifestyle intervention
Placebo control group: sugar free chunk gum 1piles/d+lifestyle intervention
Selenium nutritional supplementation
Selenium yeast, as a safe from supplementation, could be a new nutritional intervention for lifecycle regulation of type 2 diabetes.
Interventions
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Selenium nutritional supplementation
Selenium yeast, as a safe from supplementation, could be a new nutritional intervention for lifecycle regulation of type 2 diabetes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
.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.
Exclusion Criteria
.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.
18 Years
75 Years
ALL
Yes
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Yu Kang, MD
Professor
Principal Investigators
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yu kang, MD
Role: STUDY_CHAIR
Peking Union Medical College Hospital
Locations
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Yu Kang
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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Selenium-T2DM-2024
Identifier Type: -
Identifier Source: org_study_id
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