Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level: an Multicenter, Randomized, Double-blinded, Placebo-controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 主要终点
- Change of absolute value of fasting plasma glucose (mmol/L)
研究概览
简要总结
The aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine Hydrochloride on lowering glucose and delaying progress to diabetes in patients with prediabetes and to detect the potential mechanism.
详细描述
Gut microbiota may play an important role in patients with prediabetes. Berberine, which is usually used as an antibiotic drug, has been reported a potential glucose-lowering effect in vitro and in vivo studies. Bifidobacterium, as a familiar probiotics, can modulate gut microbiota and improve glucose and lipid metabolism in animal experiments. Therefore, the aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine Hydrochloride on lowering glucose and delaying progress to diabetes in patients with prediabetes and to detect the potential mechanism.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities.
- •Male or female between 18 and 70 years of old.
- •19≤Body mass index(BMI)≤30kg/m^
- •No participate in any clinical trial at least 3 months.
- •Diagnosed impaired fasting glucose(IFG) and impaired glucose tolerance(IGT) or Diabetes.
- •In visit 1, 5.60mmol/L≤Fasting plasma glucose(FPG)<8.0mmol/L; in visit 2, 6.1≤FPG<8.0mmol/L or 7.8≤2-hour postprandial plasma glucose(2h-PPG) <17mmol/L.
- •Females in child-bearing period should be given birth control.
- •No severe disease about heart, lung and kidney.
排除标准
- •Type 1 diabetes
- •Diabetes patients with previously treated or untreated FPG ≥ 8 mmol/L or 2-h PPG ≥ 17 mmol/L;
- •Women of childbearing potential who are pregnant, breastfeeding or intend to become pregnant or are not using adequate contraceptive methods.
- •Those who are allergic to study drugs
- •Unable to cooperate
- •Abnormal liver function, ALT and AST are more than 2 times of the normal upper limit
- •Renal injury, blood creatinine ≥133 µmol/L
- •Poor blood pressure control, systolic blood pressure SBP≥160mmHg and/or diastolic blood pressure DBP≥95mmHg
- •Patients with chronic gastrointestinal diseases (pancreatitis, inflammatory bowel disease) and history of intestinal surgery
- •Patients with severe heart disease, such as heart failure, unstable angina pectoris, acute myocardial infarction
- •Chronic hypoxic diseases such as emphysema, pulmonary heart disease
- •Having obvious diseases of the blood system
- •Persons with tumor diseases
- •Endocrine diseases, such as hyperthyroidism and hypercortisolism
- •Mental illness, abuse of alcohol, drugs or other substances
- •Persons with long-term oral or intravenous corticosteroid hormones therapy
- •Having stress conditions such as surgery, severe trauma, etc.
研究组 & 干预措施
Berberine Hydrochloride group
2/day, 16 weeks
干预措施: Berberine Hydrochloride group (Drug)
Bifidobacterium group
2/day, 16 weeks
干预措施: Bifidobacterium group (Drug)
Berberine Hydrochloride and Bifidobacterium group
2/day, 16 weeks
干预措施: Berberine Hydrochloride and Bifidobacterium group (Drug)
placebo
bifidobacterium mimetic capsules berberine mimetic tablets,2/day, 16 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Change of absolute value of fasting plasma glucose (mmol/L)
时间窗: baseline and week 16
Fasting plasma glucose will be measured during oral glucose tolerance test (OGTT) by glucose oxidase method at baseline and week 16.
次要结局
- Change of level of high-density lipoprotein cholesterol (mmol/L)(baseline and week 16)
- Change of abundances of gut microbiota (%)(baseline and week 16)
- Change of absolute value of 2-hour postprandial plasma glucose (mmol/L)(baseline and week 16)
- Change of level of HbA1c (%)(baseline and week 16)
- Change of level of diastolic pressure (mmHg)(baseline and week 16)
- Change of level of low-density lipoprotein cholesterol (mmol/L)(baseline and week 16)
- Change of level of homeostasis model assessment (HOMA) index(baseline and week 16)
- Change of level of serum total cholesterol (mmol/L)(baseline and week 16)
- Change of level of triglycerides (mmol/L)(baseline and week 16)
- Change of absolute value of body weight (kg)(baseline and week 16)
- Change of absolute value of body mass index (BMI) (kg/m^2)(baseline and week 16)
- Change of level of insulin early-phase secretion index(baseline and week 16)
- Change of level of GLP-1(pmol/L)(baseline and week 16)
- Change of level of systolic pressure (mmHg)(baseline and week 16)
- Change of level of insulin late-phase secretion index(baseline and week 16)