Effect Insulin Pump Therapy to Patients With Diabetic Nephropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Insulin Pump Therapy to Oxidative Stress in Patients With Diabetic Nephropathy

Conditions
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Insulin Pump Therapy in Treating Diabetic Nephropathy

Intervention / Treatment
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* Device: Insulin pump


Participation Criteria
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Eligibility Criteria
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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 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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Normal group (NC) and Type 2 diabetic (DM) group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin pump therapy<br>The total requisite amount=0.44×weight (Kg); The preprandial and basal amount respectively took up 50% of integral dose.15 minutes before meal the preprandial insulin was equally given by 3 times. The basal insulin was pumped at 00:00-3:00，3:00-8:00，8:00-14:00，14:00-20:00，20:00-24:00. | Device: Insulin pump<br>* Blood glucose management device<br>* Other names: Diabetes insulin pump;|
| No Intervention: Normal control<br>The subjects were asked to maintain normal diet and lifestyle until the end of the observation period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of 8-hydroxy-deoxyguanosine (8-OHdG) | The change of 8-hydroxy-deoxyguanosine (8-OHdG) in serum of diabetic patients with diabetic nephropathy (DN) | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of 3-nitrotyrosine (3-NT) | The change of 3-nitrotyrosine (3-NT) in serum | 2 weeks | 
| The change of glutathione (GSH) | The change of glutathione (GSH) in serum | 2 weeks | 
| The change of superoxide dismutase (SOD) | The change of superoxide dismutase (SOD) in serum | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic nephropathy, Insulin pump intensive therapy