The Impact of Insulin Pump Therapy to Oxidative Stress in Patients With Diabetic Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 主要终点
- The change of 8-hydroxy-deoxyguanosine (8-OHdG)
研究概览
简要总结
The recent study suggested that oxidative stress resulting from increased production of reactive oxygen species (ROS) plays a crucial role in the development of diabetic complications. The researches aim to monitor the level of oxidative stress of patient in different stage of diabetic nephropathy before and after insulin pump therapy.
详细描述
Worldwidely, about 30% of Type 1 Diabetes Mellitus (T1DM) and 20%-50% of T2DM patients suffered diabetic nephropathy (DN). Oxidative stress resulting from increased production of reactive oxygen species (ROS) plays a crucial role in the development of diabetic complications. Insulin pump therapy is better than subcutaneous injection in terms of the drug safety and effectiveness. The researches aim to monitor the level of oxidative stress of patient in different stage of diabetic nephropathy before and after insulin pump therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetic patients with fasting plasma glucose (FPG) ≥10mmol/l and/or 2 hours' plasma glucose (2hPG) ≥15mmol/l.
排除标准
- •Diabetic patients who
- •using antioxidant drugs within one month;
- •accompanied with acute and chronic severe complications, fever, malignant tumor, nephritis, congestive heart failure.
- •accompanied with diabetic ketosis, ketoacidosis, severe hypoglycemia, hyperosmolar hyperglycemic state;
- •with other endocrine diseases, autoimmune diseases, or connective tissue diseases;
- •having history of infection within 1 month;
- •having drug or alcohol dependence;
- •severe hypoxia and stress state (e.g., cardiovascular events, trauma, surgery, and consumptive disease, etc.)
结局指标
主要结局
The change of 8-hydroxy-deoxyguanosine (8-OHdG)
时间窗: 2 weeks
The change of 8-hydroxy-deoxyguanosine (8-OHdG) in serum of diabetic patients with diabetic nephropathy (DN)
次要结局
- The change of glutathione (GSH)(2 weeks)
- The change of 3-nitrotyrosine (3-NT)(2 weeks)
- The change of superoxide dismutase (SOD)(2 weeks)
研究者
Xiaofeng Lv
Principal investigator
Chinese PLA General Hospital