Type 2 DiabetesNCT06457984
Effects of Selenium Towards Type 2 Diabetes
A study testing Selenium nutritional supplementation in people with Type 2 Diabetes, run by Peking Union Medical College Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Selenium nutritional supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2024to 7 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- .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.
Who cannot join
- .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;
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- .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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Selenium nutritional supplementation
- Keywords
- selenium, intervention, glucose, nutritional status, clinical outcome
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selenium nutritional supplementationDietary supplement
Also called lifestyle intervention
Selenium yeast, as a safe from supplementation, could be a new nutritional intervention for lifecycle regulation of type 2 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Low dose selenium supplementation group+lifestyle intervention | Experimental | Low dose selenium supplementation:50μg/d +lifestyle intervention Receives: Dietary Supplement: Selenium nutritional supplementation |
| High dose selenium supplementation group+lifestyle intervention | Experimental | High dose selenium supplementation :300μg/d+lifestyle intervention Receives: Dietary Supplement: Selenium nutritional supplementation |
| Placebo control group+lifestyle intervention | Placebo comparator | Placebo control group: sugar free chunk gum 1piles/d+lifestyle intervention Receives: Dietary Supplement: Selenium nutritional supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drugs of reduce glucose or stop using the antidiabetics.
Dose or types of antidiabetics drugs would reduce.
Measured: 12 weeks
Secondary outcomes (4)
GPX activity
Level of GPX-1 activity would decrease alone with the supplementation of selenium
Measured: 12 weeks
Situation of glucose
Level of glucose would decrease alone with the supplementation of selenium
Measured: 12 weeks
Nutrition status of selenium
Content of selenium in serum would increase alone with the supplementation of selenium
Measured: 12 weeks
Status of immunity
Level of immunity indicator serum iron would increase along with the supplementation of selenium
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion7 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Kang, MD, Peking Union Medical College Hospital
- Investigators
- yu kang, MD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457984
- Sponsor's protocol ID
- Selenium-T2DM-2024
- Status last verified
- Jun 2024
- First submitted
- 8 May 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only be known by the research who do the work of random lottery method in this study.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Selenium Nutritional Supplement of Glucose, Nutritional Status, and Clinical Outcome Among Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT06457984
- Acronym / sponsor ID
- Selenium-T2DM-2024
- Conditions
- Type 2 Diabetes
- Keywords
- selenium, intervention, glucose, nutritional status, clinical outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 7 May 2025 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Low dose selenium supplementation group+lifestyle intervention | Experimental | Dietary Supplement: Selenium nutritional supplementationLow dose selenium supplementation:50μg/d +lifestyle intervention |
| High dose selenium supplementation group+lifestyle intervention | Experimental | Dietary Supplement: Selenium nutritional supplementationHigh dose selenium supplementation :300μg/d+lifestyle intervention |
| Placebo control group+lifestyle intervention | Placebo comparator | Dietary Supplement: Selenium nutritional supplementationPlacebo control group: sugar free chunk gum 1piles/d+lifestyle intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- .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.
Key exclusion criteria (11 listed)
- .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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selenium nutritional supplementationAlso: lifestyle interventionSelenium yeast, as a safe from supplementation, could be a new nutritional intervention for lifecycle regulation of type 2 diabetes. | Dietary supplement | High dose selenium supplementation group+lifestyle intervention, Low dose selenium supplementation group+lifestyle intervention, Placebo control group+lifestyle intervention |
Primary outcome
Drugs of reduce glucose or stop using the antidiabetics.
Time frame: 12 weeks
Dose or types of antidiabetics drugs would reduce.
4 secondary outcomes
GPX activity
Time frame: 12 weeks
Situation of glucose
Time frame: 12 weeks
Nutrition status of selenium
Time frame: 12 weeks
Status of immunity
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No. Only be known by the research who do the work of random lottery method in this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yu kang, MD study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selenium nutritional supplementation in people with Type 2 Diabetes, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yu kang, MD (+86 13801130457, yuk1997@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drugs of reduce glucose or stop using the antidiabetics. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.