Insulin Pump Therapy in Treating Diabetic Nephropathy
Conditions
Keywords
Diabetic nephropathy, Insulin pump intensive therapy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEInsulin pump
Blood glucose management device
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Normal group (NC) and Type 2 diabetic (DM) group
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Diabetic patients with fasting plasma glucose (FPG) ≥10mmol/l and/or 2 hours' plasma glucose (2hPG) ≥15mmol/l.
Exclusion criteria
Diabetic patients who 1. using antioxidant drugs within one month; 2. accompanied with acute and chronic severe complications, fever, malignant tumor, nephritis, congestive heart failure. 3. accompanied with diabetic ketosis, ketoacidosis, severe hypoglycemia, hyperosmolar hyperglycemic state; 4. with other endocrine diseases, autoimmune diseases, or connective tissue diseases; 5. having history of infection within 1 month; 6. having drug or alcohol dependence; 7. severe hypoxia and stress state (e.g., cardiovascular events, trauma, surgery, and consumptive disease, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of 8-hydroxy-deoxyguanosine (8-OHdG) | 2 weeks | The change of 8-hydroxy-deoxyguanosine (8-OHdG) in serum of diabetic patients with diabetic nephropathy (DN) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of 3-nitrotyrosine (3-NT) | 2 weeks | The change of 3-nitrotyrosine (3-NT) in serum |
| The change of glutathione (GSH) | 2 weeks | The change of glutathione (GSH) in serum |
| The change of superoxide dismutase (SOD) | 2 weeks | The change of superoxide dismutase (SOD) in serum |
Outcome results
None listed