Effect Insulin Pump Therapy to Patients With Diabetic Nephropathy

Not Applicable

Completed

• Conditions: Insulin Pump Therapy in Treating Diabetic Nephropathy
• Interventions: Device: Insulin pump

• Registration Number: NCT03174821
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study Start: 2010-10-20
• Primary Completion: 2014-05-16
• Study Completion: 2014-05-16
• Status Verified: 2017-05
• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-05-31
• Last Update Submitted: 2017-05-31
• Study First Posted: 2017-06-05
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin pump therapy	Insulin pump	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The change of glutathione (GSH)	2 weeks	The change of glutathione (GSH) in serum
The change of 3-nitrotyrosine (3-NT)	2 weeks	The change of 3-nitrotyrosine (3-NT) in serum
The change of superoxide dismutase (SOD)	2 weeks	The change of superoxide dismutase (SOD) in serum