Effect of Metformin as add-on Therapy on Glycemic Control and Other Diabetes-Related Outcomes in Type 1 Diabetic Patients:a Open-label,Self-control Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of hemoglobin A1c in percentage
研究概览
简要总结
Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 1 diabetes is increasing. However, the effect of multistrain probiotics in people with type 1 diabetes remains unclear. This study investigated the effect of metformin as add-on therapy on glycemic control and other diabetes-related outcomes in people with type 1 diabetes.
详细描述
Design An open-label, add-on, self-control clinical trial. Setting Diabetes clinic of a teaching hospital in Shenzhen China Participants A total of 20 participants with type 1 diabetes, aged 18-60 years, will be recruited and treated with metformin as add-on therapy with insulin for 12 weeks.
Outcomes Primary outcomes were glycemic control related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The gut microbiota profile will be analyzed before and after intervention .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes patients age 18-60years old 18 Kg/m2≤BMI≤30Kg/m2 ketonuria (-)；
排除标准
- •pregnancy lactation having other severe chronic illnesses taking other anti-diabetic drugs
研究组 & 干预措施
metformin
patients take metformin 500mg twice or three times a day as add-on therapy to insulin for 3 months ,using self-control method.
干预措施: Metformin (Drug)
结局指标
主要结局
Change of hemoglobin A1c in percentage
时间窗: 3 months
analyze the change of hemoglobin A1c before and after the treatment
次要结局
- Change of weight in kilograms(3 months)