Type 2 DiabetesNCT05320510
Effect of Selenium Supplementation on Glycemic Control in Patients With Type 2 Diabetes or Prediabetes
A study testing Se-yeast in people with Type 2 Diabetes and PreDiabetes, run by Huazhong University of Science and Technology.
Trial summary
Although it has been suggested that selenium (Se) increases the risk of T2DM, most evidence comes from observational studies that cannot prove causality. A systematic review assessed randomized clinical trials and found that the risk of T2DM was not greater in those randomized to Se supplementation than in those… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes, PreDiabetes
- What is being tested?
- Se-yeast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Mar 2023
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FPG ≥ 5.6 mmol/L;
- HbA1c ≥ 5.7%;
- OGTT 2h or postprandial blood glucose ≥ 7.8 mmol/L.
- T2D patients with stable anti-diabetic medication and blood glucose controlled well for 4 weeks prior.
Who cannot join
- Under 30 years old or above 70 years old;
- Pregnancy;
- Major surgery in the previous 6 months or planned to occur during the trail;
- Insulin injection for diabetes;
- Suffering from severe obesity (BMI > 40 kg/m2), immunodeficiency syndrome, thyroid disease, coronary heart disease, stroke, malignant neoplasm, kidney or liver disease, or other serious diseases, such as mental illness;
- Reduced kidney function (GFR < 60 mL/min/1.73m2, creatinine > 1.2 times the normal upper limit [male, > 133.2 μmol/L; female > 100 μmol/L]);
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- Systolic or diastolic blood pressure greater than 160 or 100 mmHg;
- Taking dietary supplements (e.g., selenium, vitamin, fish oil, etc.) for nearly one month before the intervention;
- Taking antibiotics or probiotics within 12 weeks of screening.
About this study
Official title: Effect of Selenium Supplementation on Glycemic Control in Patients With Type 2 Diabetes or Prediabetes: a Double Blinded, Randomized Controlled Trail
Although it has been suggested that selenium (Se) increases the risk of T2DM, most evidence comes from observational studies that cannot prove causality. A systematic review assessed randomized clinical trials and found that the risk of T2DM was not greater in those randomized to Se supplementation than in those randomized to placebo. Se is a toxic element in animals and humans, and overexposure to Se has also been linked to detrimental health effects in humans. Previous studies were mostly conducted in Se-sufficient areas. Moreover, the effectiveness of low-dose Se supplementation on participants with elevated glycemic status was unknown. This cross-over, double blinded, randomized controlled trail aimed to investigate the effectiveness of Se supplementation for glucose control among participants with diabetes or prediabetes. Moreover, we also aimed to examine whether selenoprotein P genotypes, Se-related gut microbiota and their related metabolite modified the effectiveness.
- Conditions
- Type 2 Diabetes, PreDiabetes
- Being tested
- Se-yeast, Placebo
- Keywords
- selenium, Type 2 Diabetes, prediabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Se-yeastDietary supplement
The participants will be asked to take Se-yeast tablet. The intervention period is about 3 months. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
PlaceboDietary supplement
The participants will be asked to take placebo-yeast tablet. The intervention period is about 3 months. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
| Study group | Role | What they receive |
|---|---|---|
| Se-yeast | Experimental | Selenium-enriched yeast tablet (Se, 50 μg/d) Receives: Dietary Supplement: Se-yeast |
| Placebo | Placebo comparator | placebo-yeast tablet Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HbA1c concentration
Change of glycated hemoglobin concentration
Measured: 0 week, 4th week, 8th week, and 12th week in the intervention period
Secondary outcomes (5)
Change of FPG concentration
Change of fasting plasma glucose concentration
Measured: 0 week, 4th week, 8th week, and 12th week in the intervention period
Change of FPI concentration
Change of fasting plasma insulin concentration
Measured: 0 week, 4th week, 8th week, and 12th week in the intervention period
Change of HOMA-IR
Change of homeostasis model of assessment-insulin resistance
Measured: 0 week, 4th week, 8th week, and 12th week in the intervention period
Change of TG concentration
Change of serum triglyceride concentration
Measured: 0 week, 4th week, 8th week, and 12th week in the intervention period
Change of TC concentration
Change of total cholesterol concentration
Measured: 0 week, 4th week, 8th week, and 12th week in the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Mar 2023 (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 Huazhong University of Science and TechnologyThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liegang Liu, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320510
- Sponsor's protocol ID
- LK20220322
- Status last verified
- Jun 2022
- First submitted
- 22 Mar 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Selenium Supplementation on Glycemic Control in Patients With Type 2 Diabetes or Prediabetes: a Double Blinded, Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT05320510
- Acronym / sponsor ID
- LK20220322
- Conditions
- Type 2 Diabetes, PreDiabetes
- Keywords
- selenium, Type 2 Diabetes, prediabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 11 Apr 2022 (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.
Although it has been suggested that selenium (Se) increases the risk of T2DM, most evidence comes from observational studies that cannot prove causality. A systematic review assessed randomized clinical trials and found that the risk of T2DM was not greater in those randomized to Se supplementation than in those randomized to placebo. Se is a toxic element in animals and humans, and overexposure to Se has also been linked to detrimental health effects in humans. Previous studies were mostly conducted in Se-sufficient areas. Moreover, the effectiveness of low-dose Se supplementation on participants with elevated glycemic status was unknown. This cross-over, double blinded, randomized controlled trail aimed to investigate the effectiveness of Se supplementation for glucose control among participants with diabetes or prediabetes. Moreover, we also aimed to examine whether selenoprotein P genotypes, Se-related gut microbiota and their related metabolite modified the effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Se-yeast | Experimental | Dietary Supplement: Se-yeastSelenium-enriched yeast tablet (Se, 50 μg/d) |
| Placebo | Placebo comparator | Dietary Supplement: Placeboplacebo-yeast tablet |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- FPG ≥ 5.6 mmol/L;
- HbA1c ≥ 5.7%;
- OGTT 2h or postprandial blood glucose ≥ 7.8 mmol/L.
- T2D patients with stable anti-diabetic medication and blood glucose controlled well for 4 weeks prior.
Key exclusion criteria (9 listed)
- Under 30 years old or above 70 years old;
- Pregnancy;
- Major surgery in the previous 6 months or planned to occur during the trail;
- Insulin injection for diabetes;
- Suffering from severe obesity (BMI > 40 kg/m2), immunodeficiency syndrome, thyroid disease, coronary heart disease, stroke, malignant neoplasm, kidney or liver disease, or other serious diseases, such as mental illness;
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 |
|---|---|---|
| Se-yeastThe participants will be asked to take Se-yeast tablet. The intervention period is about 3 months. Do not take any other medicine, traditional Chinese medicine, or dietary supplements. | Dietary supplement | Se-yeast |
| PlaceboThe participants will be asked to take placebo-yeast tablet. The intervention period is about 3 months. Do not take any other medicine, traditional Chinese medicine, or dietary supplements. | Dietary supplement | Placebo |
Primary outcome
Change of HbA1c concentration
Time frame: 0 week, 4th week, 8th week, and 12th week in the intervention period
Change of glycated hemoglobin concentration
5 secondary outcomes
Change of FPG concentration
Time frame: 0 week, 4th week, 8th week, and 12th week in the intervention period
Change of FPI concentration
Time frame: 0 week, 4th week, 8th week, and 12th week in the intervention period
Change of HOMA-IR
Time frame: 0 week, 4th week, 8th week, and 12th week in the intervention period
Change of TG concentration
Time frame: 0 week, 4th week, 8th week, and 12th week in the intervention period
Change of TC concentration
Time frame: 0 week, 4th week, 8th week, and 12th week in the intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Se-yeast in people with Type 2 Diabetes and PreDiabetes, run by Huazhong University of Science and Technology.
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 9 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 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of HbA1c concentration (time frame: 0 week, 4th week, 8th week, and 12th week in the intervention period). 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 6 Jun 2022.