Effect of Selenium Supplementation on Glycemic Control in Patients With Type 2 Diabetes or Prediabetes

N/AUnknownNCT05320510

Huazhong University of Science and Technology130 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

130

Conditions

Type 2 Diabetes PreDiabetes

Interventions

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.