Effects of Selenium Towards Type 2 Diabetes

NCT06457984 | Not Yet Recruiting

• 1 other identifier: Selenium-T2DM-2024
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

selenium; intervention; glucose; nutritional status; clinical outcome

Outcome Measures

Primary Outcomes (1)

• Drugs of reduce glucose or stop using the antidiabetics.

  Dose or types of antidiabetics drugs would reduce.

  12 weeks

Secondary Outcomes (4)

• GPX activity

  12 weeks

• Situation of glucose

  12 weeks

• Nutrition status of selenium

  12 weeks

• Status of immunity

  12 weeks

Study Arms (3)

Low dose selenium supplementation group+lifestyle intervention

EXPERIMENTAL

Low dose selenium supplementation:50μg/d +lifestyle intervention

Dietary Supplement: Selenium nutritional supplementation

High dose selenium supplementation group+lifestyle intervention

EXPERIMENTAL

High dose selenium supplementation :300μg/d+lifestyle intervention

Dietary Supplement: Selenium nutritional supplementation

Placebo control group+lifestyle intervention

PLACEBO COMPARATOR

Placebo control group: sugar free chunk gum 1piles/d+lifestyle intervention

Dietary Supplement: Selenium nutritional supplementation

Interventions

Selenium nutritional supplementation DIETARY_SUPPLEMENT

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

Also known as: lifestyle intervention

High dose selenium supplementation group+lifestyle intervention; Low dose selenium supplementation group+lifestyle intervention; Placebo control group+lifestyle intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: The criteria about gender identity should be suit to the related legislation.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Yu Kang

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• yu kang, MD

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

yu kang, MD

CONTACT

+86 13801130457; yuk1997@sina.com

Li Yanping, PhD

CONTACT

+86 13430273762; 1204571005@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double(Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: June 13, 2024
• Study Start: June 15, 2024
• Primary Completion: June 15, 2024
• Study Completion: May 7, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)