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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin pump therapy | Experimental | 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. |
|
| Normal control | No Intervention | The subjects were asked to maintain normal diet and lifestyle until the end of the observation period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin pump | Device | Blood glucose management device |
|
| 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 |
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Min Liu | Center for Drug Evaluation, China food and Drug Administration | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29433562 | Derived | Zhang XG, Zhang YQ, Cheng QP, Cao Y, Sun JM, Lv XF. The impact of insulin pump therapy to oxidative stress in patients with diabetic nephropathy. Eur J Med Res. 2018 Feb 12;23(1):7. doi: 10.1186/s40001-018-0304-2. |
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The individual participant data (IPD) was not allowed to use outside this research.
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D007332 | Insulin Infusion Systems |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
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Normal group (NC) and Type 2 diabetic (DM) group
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| 2 weeks |
| The change of superoxide dismutase (SOD) | The change of superoxide dismutase (SOD) in serum | 2 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D004864 |
| Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |