Clinical trial NCT06457984: Effects of Selenium Towards Type 2 Diabetes
Official title: Effects of Selenium Nutritional Supplement of Glucose, Nutritional Status, and Clinical Outcome Among Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: selenium
intervention
glucose
nutritional status
clinical outcome
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

.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.

Exclusion Criteria:

.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.

Primary outcomes:
measure: Drugs of reduce glucose or stop using the antidiabetics.
timeFrame: 12 weeks
Secondary outcomes:
measure: GPX activity
timeFrame: 12 weeks
measure: Situation of glucose
timeFrame: 12 weeks
measure: Nutrition status of selenium
timeFrame: 12 weeks
measure: Status of immunity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yu Kang
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: yu kang, MD
role: STUDY_CHAIR
References: