Effects of Selenium Towards Type 2 Diabetes

June 11, 2024 updated by: Yu Kang, MD, Peking Union Medical College Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Yu Kang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose selenium supplementation group+lifestyle intervention
Low dose selenium supplementation:50μg/d +lifestyle 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.
Other Names:
  • lifestyle intervention
Experimental: High dose selenium supplementation group+lifestyle intervention
High dose selenium supplementation :300μg/d+lifestyle 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.
Other Names:
  • lifestyle intervention
Placebo Comparator: Placebo control group+lifestyle intervention
Placebo control group: sugar free chunk gum 1piles/d+lifestyle 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.
Other Names:
  • lifestyle intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drugs of reduce glucose or stop using the antidiabetics.
Time Frame: 12 weeks
Dose or types of antidiabetics drugs would reduce.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GPX activity
Time Frame: 12 weeks
Level of GPX-1 activity would decrease alone with the supplementation of selenium
12 weeks
Situation of glucose
Time Frame: 12 weeks
Level of glucose would decrease alone with the supplementation of selenium
12 weeks
Nutrition status of selenium
Time Frame: 12 weeks
Content of selenium in serum would increase alone with the supplementation of selenium
12 weeks
Status of immunity
Time Frame: 12 weeks
Level of immunity indicator serum iron would increase along with the supplementation of selenium
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: yu kang, MD, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2024

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

May 7, 2025

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Selenium-T2DM-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only be known by the research who do the work of random lottery method in this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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