Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level

Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level: an Multicenter, Randomized, Double-blinded, Placebo-controlled Study.

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.

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.

Inclusion Criteria:

• 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^2.
• 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.

Exclusion Criteria:

• 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.