Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Type 2 Diabetes: a Randomized, Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change from baseline in glycosylated hemoglobin change at 3 months
研究概览
简要总结
The purpose of this study is to determine whether the probiotics is effective in the treatment of type 2 diabetes.
详细描述
This study aims to evaluate the effect of probiotics on the improvement of glucose and lipid metabolism, as well as the gut microbiota.Baseline, 1 month and 3 month data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical practice for type 2 diabetes patients.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-80 years
- •Confirmed type 2 diabetes patients with Oral antidiabetic agents
- •Agree to cooperate in the trial
- •Provision of written informed consent
排除标准
- •With chronic gastrointestinal diseases, severe immune deficiency, lactose intolerance
- •Type 1 diabetes
- •Treated with insulin or an insulin analogue in the last 6 months
- •Use antibiotics, bacteriostatic agents (eg berberine), lipid-lowering drugs, antacids, H2 Blockers, proton pump inhibitors, corticosteroids or sex hormones
- •Use any probiotics in the last 3 months
- •Participating in any other clinical trials
- •Was not able to insist until the end
- •Pregnant and lactating women
结局指标
主要结局
change from baseline in glycosylated hemoglobin change at 3 months
时间窗: 3 months
change of the glycosylated hemoglobin will be calculated at 3 months in comparison with the baseline
change from baseline in fasting blood-glucose at 1 month
时间窗: 1 month
change of the fasting blood-glucose will be calculated at 1 month in comparison with the baseline
change from baseline in glycosylated hemoglobin change at 1 month
时间窗: 1 month
change of the glycosylated hemoglobin will be calculated at 1 month in comparison with the baseline
change from baseline in fasting blood-glucose at 3 months
时间窗: 3 months
change of the fasting blood-glucose will be calculated at 3 months in comparison with the baseline
次要结局
- change from baseline in low-density lipoprotein at 1 month(1 month)
- change from baseline in alkaline transaminase at 1 month(1 month)
- change from baseline in alkaline transaminase at 3 months(3 months)
- change from baseline in gut microbiota at 1 month(1 month)
- change from baseline in triglyceride at 1 month(1 month)
- change from baseline in glutamic oxalacetic transaminase at 3 months(3 months)
- change from baseline in C-reactive protein at 3 months(3 months)
- change from baseline in alkaline phosphatase at 1 month(1 month)
- change from baseline in alkaline phosphatase at 3 months(3 months)
- change from baseline in superoxide dismutase at 3 months(3 months)
- change from baseline in triglyceride at 3 months(3 months)
- change from baseline in cholesterol at 1 month(1 month)
- change from baseline in C-reactive protein at 1 month(1 month)
- change from baseline in gut microbiota at 3 months(3 months)
- change from baseline in cholesterol at 3 months(3 months)
- change from baseline in high-density lipoprotein at 3 months(3 months)
- change from baseline in low-density lipoprotein at 3 months(3 months)
- change from baseline in superoxide dismutase at 1 month(1 month)
- change from baseline in high-density lipoprotein at 1 month(1 month)
- change from baseline in glutamic oxalacetic transaminase at 1 month(1 month)
- change from baseline in interleukin-6 at 1 month(1 month)
- change from baseline in fasting insulin at 1 month(1 month)
- change from baseline in fasting insulin at 3 months(3 months)
- change from baseline in uric acid at 1 month(1 month)
- change from baseline in uric acid at 3 months(3 months)
- change from baseline in interleukin-8 at 1 month(1 month)
- change from baseline in interleukin-8 at 3 months(3 months)
- change from baseline in c peptide at 1 month(1 month)
- change from baseline in tumor necrosis factor-a at 3 months(3 months)
- change from baseline in c peptide at 3 months(3 months)
- change from baseline in tumor necrosis factor-a at 1 month(1 month)
- change from baseline in interleukin-6 at 3 months(3 months)
研究者
Huanlong Qin
Professor
Shanghai 10th People's Hospital