Effect of Selenium Supplementation on Glycemic Control in Patients With Type 2 Diabetes or Prediabetes: a Double Blinded, Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 主要终点
- Change of HbA1c concentration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Under 30 years old or above 70 years old;
- •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]);
- •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.
结局指标
主要结局
Change of HbA1c concentration
时间窗: 0 week, 4th week, 8th week, and 12th week in the intervention period
Change of glycated hemoglobin concentration
次要结局
- Change of FPG concentration(0 week, 4th week, 8th week, and 12th week in the intervention period)
- Change of FPI concentration(0 week, 4th week, 8th week, and 12th week in the intervention period)
- Change of TG concentration(0 week, 4th week, 8th week, and 12th week in the intervention period)
- Change of TC concentration(0 week, 4th week, 8th week, and 12th week in the intervention period)
- Change of HOMA-IR(0 week, 4th week, 8th week, and 12th week in the intervention period)
研究者
Liegang Liu
Professor
Huazhong University of Science and Technology