Effect of Berberine on Insulin Release at a High Blood Glucose Level in Normal Man
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Differences of serum insulin levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
研究概览
简要总结
Berberine (BBR) is a traditional Chinese medicine used to treat diabetes mellitus for thousands of years in China. The glucose-lowering effect of BBR has been confirmed in numerous studies. Nevertheless, the detailed mechanisms of action through which BBR exerts its effects are not yet fully elucidated. In previous data, Jin-Kui Yang found that BBR could promote insulin secretion in mice and isolated islets. In this current study, investigators plan to examine the insulinotropic effect of BBR in human through hyperglycemic clamp method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult healthy male, aged ≥18 and ≤45 years old.
- •Subject/ legal representative is able to understand and sign informed consent form.
- •Body mass index (BMI) 18-25 kg/m
- •Normal oral glucose tolerance test prior to study.
- •No family history of diabetes mellitus.
- •No medication treatment within 4 weeks prior to baseline visit and during the study.
- •Willing and able to comply with all study-related procedures, including not incorporating significant changes in diet.
排除标准
- •Infection with hepatitis (A, B, or C), HIV and syphilis.
- •History of allergic reaction to berberine or any component in the formulation of the study drugs.
- •Cumulative amount of blood loss (eg. blood donation) over 400mL within 3 months prior to baseline visit and during the study.
- •Alcohol drinking within 2 weeks prior to baseline visit and during the study.
- •Use of illegal drugs or positive in urine drugs screen.
- •Smoke during the study.
研究组 & 干预措施
Berberine treatment
干预措施: Berberine Chloride (Drug)
Berberine treatment
干预措施: Placebo (Drug)
Placebo control
干预措施: Berberine Chloride (Drug)
Placebo control
干预措施: Placebo (Drug)
结局指标
主要结局
Differences of serum insulin levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
时间窗: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
To compare the mean serum insulin levels in the two groups during hyperglycemic clamp study.
Differences of serum C-peptide levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
时间窗: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
To compare the mean serum C-peptide levels in the two groups during hyperglycemic clamp study.
次要结局
- Differences of glucose infusion rates between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.(Single dosage for one experiment and crossover repeat once after 2 weeks washout period)
- Differences of blood glucose levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.(Single dosage for one experiment and crossover repeat once after 2 weeks washout period)
研究者
Jin-Kui Yang
Professor, PhD
Beijing Tongren Hospital