Response of Gut Microbiota in Type 2 Diabetes to Hypoglycemic Agents
试验速览
- 阶段
- 4 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Changes from baseline to post-treatment in composition in gut microbiota analyzed by meta-genome sequencing.
研究概览
简要总结
Intestinal microflora refers to the trillions of microorganisms living in our gut, which is considered as an independent endocrine organ of human body. Intestinal microbiota plays a very important role in human health. The composition of human intestinal microbiota is affected by a variety of factors, including age, living region, eating habits, nutrition, probiotics, antibiotics and so on. It is found that the imbalance of intestinal microbiota is closely related to the occurrence and development of metabolic diseases including type 2 diabetes mellitus (T2DM). There are great differences in the structure and function of intestinal microbiota between healthy people and T2DM patients, and recently changes of intestinal microbiota have been observed in pre-diabetes. In recent years, it has been found that some commonly used hypoglycemic drugs may regulate and improve the imbalance of intestinal flora of T2DM patients, including metformin, α - glucosidase inhibitor, and Glucagon-like peptide-1(GLP-1) receptor agonist, which have a positive impact on the short chain fatty acid (SCFAs) producing bacteria. However, on the one hand, subjects of those studies were mostly western population and there were just a few studies on the influence of anti-diabetic drug on human gut microbiota in Chinese population, on the other hand, the study of influence of Dipeptidyl peptidase-4(DPP-4) inhibitors, sulfonylureas, sodium-dependent glucose transporters-2(SGLT-2) inhibitors or thiazolidinediones on intestinal microbiota is rare or even absent. This study aims to explore the effect of different hypoglycemic drugs on intestinal flora and find the potential intestinal target of drug action in Chinese population.
详细描述
In this study, T2DM patients who were free of anti-diabetic drugs or those have taken hypoglycemic drugs and ready to add a new drug were recruited, they were treated with metformin, α - glucosidase inhibitor, DPP-4 inhibitors, sulfonylureas, SGLT-2 inhibitors, or thiazolidinediones according to their state of illness. Faecal specimen will be collected for test of composition of gut microbiota at baseline and 4-week, 8-week，12-week after taking medication. At baseline, patients will take physical examination and blood test, every patient will complete the questionnaire under the direction of doctors to get their general information and diet habits. Physical examination and blood test will repeat at 4-week, 8-week，12-week after treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the diagnostic criteria of World Health Organization (WHO) in 1999, type 2 diabetes mellitus was diagnosed clinically
- •The age ranged from 18 to 65 years (including 18 and 65 years)
- •Free of hypoglycemic drugs in the past 3 months; or have taken hypoglycemic drugs, and other hypoglycemic drugs need to be added at present.
- •Sign written consent form voluntarily
排除标准
- •Other types of diabetes mellitus
- •At least in the last 1 month, no antibiotics or microbial agents have been used
- •History of infectious diseases such as tuberculosis, viral hepatitis, HIV, and periodontal disease; history of dental disease
- •Acute complications of diabetes mellitus within 6 months
- •History of myocardial infarction or stroke within 6 months, or existing severe cardiovascular disease and risk
- •Abnormal liver function [i.e. serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 1.5 times higher than the upper limit of normal value]；Abnormal renal function [glomerular filtration rate≤60 ml/min]
- •Severe hypertension that defined as systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥90 mmHg with drug therapy, or hypotension (resting seat blood pressure < 90/50 mmHg)
- •History of acute and chronic gastroenteritis or gastrointestinal surgery
- •psychosis, alcohol dependence or history of drug abuse, lactation women, participation in other studies three months before the trial, allergic constitution or allergic to a variety of drug and those researchers think inappropriate to the research.
研究组 & 干预措施
Dapagliflozin group
干预措施: Dapagliflozin Tablet (Drug)
Acarbose group
干预措施: Acarbose Tablets (Drug)
Glucophage group
干预措施: Glucophage 500Mg Tablet (Drug)
Sitagliptin group
干预措施: Sitagliptin tablet (Drug)
Pioglitazone group
干预措施: Pioglitazone Tablets (Drug)
Glimepiride group
干预措施: Glimepiride Tablets (Drug)
结局指标
主要结局
Changes from baseline to post-treatment in composition in gut microbiota analyzed by meta-genome sequencing.
时间窗: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of IL-10.
时间窗: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in fasting blood glucose.
时间窗: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of TNF-a.
时间窗: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in blood lipid including cholesterol, triglycerides, high-density lipoprotein.
时间窗: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in 2-hour postprandial blood glucose.
时间窗: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of IL-6.
时间窗: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in fasting insulin.
时间窗: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of IL-8.
时间窗: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of C-reative protein.
时间窗: Baseline, Week 4, Week 8, Week 12
次要结局
- The linear relationship between gut microbiota and blood glucose and blood lipid level.(Week 4, Week 8, Week 12)
- The linear relationship between gut microbiota and inflammation factors level.(Week 4, Week 8, Week 12)