Effects of Selenium Towards Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Effects of Selenium Nutritional Supplement of Glucose, Nutritional Status, and Clinical Outcome Among Type 2 Diabetes Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457984
• Other study ID #: Selenium-T2DM-2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: May 7, 2025

Study information

• Verified date: June 2024
• Source: Peking Union Medical College Hospital
• Contact: yu kang, MD
• Phone: +86 13801130457
• Email: yuk1997[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 7, 2025
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Selenium nutritional supplementation
Selenium yeast, as a safe from supplementation, could be a new nutritional intervention for lifecycle regulation of type 2 diabetes.

Locations

Country	Name	City	State
China	Yu Kang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drugs of reduce glucose or stop using the antidiabetics.	Dose or types of antidiabetics drugs would reduce.	12 weeks
Secondary	GPX activity	Level of GPX-1 activity would decrease alone with the supplementation of selenium	12 weeks
Secondary	Situation of glucose	Level of glucose would decrease alone with the supplementation of selenium	12 weeks
Secondary	Nutrition status of selenium	Content of selenium in serum would increase alone with the supplementation of selenium	12 weeks
Secondary	Status of immunity	Level of immunity indicator serum iron would increase along with the supplementation of selenium	12 weeks