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Effects of selenium nutritional supplement of glucose,nutritional status, and clinical outcome among type 2 diabetes patients

Effects of selenium nutritional supplement of glucose,nutritional status, and clinical outcome among type 2 diabetes patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084063
Enrollment
Unknown
Registered
2024-05-09
Start date
2024-05-10
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

low dose group:Intervention with low dose selenium (50µg/d)
high dose group :Intervention with low dose selenium (300µg/d)
control group :Intervention with sugar free chunk gum (a pile/d)

Sponsors

Peking Union Medical of College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Range of age:18~75, both males and females are permitted. (2) 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. (3) 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. (4) Signed with the informed consent, and enrolled in this study in volunteer.

Exclusion criteria

Exclusion criteria: (1)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. (2)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. (3)Patients suffering various serious chronic diseases, including unstable angina, uncontrolled arrhythmia, severe valvular heart disease or cardiomyopathy; (4)Uncontrolled hypertension or blood pressure over 180/110mmHg; (5)In the period of trying to conceive or pregnant or lactating. (6)Patients who have had cerebral infarction, stroke, history of major surgery, acute attack of infectious diseases or obvious sequelae of infection; (7)Sever psychology disorders and mental diseases. (8)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; (9)Severe malnutrition and overnutrition; (10)Significant mobility and cognitive impairment; (11)Sickle cell disease, hemodialysis, recent blood loss or blood transfusion, etc.

Design outcomes

Secondary

MeasureTime frame
GPX activity;Nutrition status of selenium;The level of glucose;The situation of blood pressure;Status of immunity;

Primary

MeasureTime frame
Drugs of reduce glucose or stop using the antidiabetes;

Countries

China

Contacts

Public ContactYu Kang

Peking Union Medical College Hospital (PUMCH)

yukang1997@sina.com+86 138 0113 0457

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026