PreDiabetes, Type 2 Diabetes
Conditions
Keywords
selenium, Type 2 Diabetes, prediabetes
Brief 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 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.
Interventions
DIETARY_SUPPLEMENTSe-yeast
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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. FPG ≥ 5.6 mmol/L; 2. HbA1c ≥ 5.7%; 3. OGTT 2h or postprandial blood glucose ≥ 7.8 mmol/L. 4. T2D patients with stable anti-diabetic medication and blood glucose controlled well for 4 weeks prior.
Exclusion criteria
1. Under 30 years old or above 70 years old; 2. Pregnancy; 3. Major surgery in the previous 6 months or planned to occur during the trail; 4. Insulin injection for diabetes; 5. 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; 6. Reduced kidney function (GFR \< 60 mL/min/1.73m2, creatinine \> 1.2 times the normal upper limit \[male, \> 133.2 μmol/L; female \> 100 μmol/L\]); 7. Systolic or diastolic blood pressure greater than 160 or 100 mmHg; 8. Taking dietary supplements (e.g., selenium, vitamin, fish oil, etc.) for nearly one month before the intervention; 9. Taking antibiotics or probiotics within 12 weeks of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of HbA1c concentration | 0 week, 4th week, 8th week, and 12th week in the intervention period | Change of glycated hemoglobin concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of FPG concentration | 0 week, 4th week, 8th week, and 12th week in the intervention period | Change of fasting plasma glucose concentration |
| Change of FPI concentration | 0 week, 4th week, 8th week, and 12th week in the intervention period | Change of fasting plasma insulin concentration |
| Change of TC concentration | 0 week, 4th week, 8th week, and 12th week in the intervention period | Change of total cholesterol concentration |
| Change of HOMA-IR | 0 week, 4th week, 8th week, and 12th week in the intervention period | Change of homeostasis model of assessment-insulin resistance |
| Change of TG concentration | 0 week, 4th week, 8th week, and 12th week in the intervention period | Change of serum triglyceride concentration |
Outcome results
None listed