Effect Insulin Pump Therapy to Patients With Diabetic Nephropathy

Insulin Pump Therapy in Treating Diabetic Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174821
• Other study ID #: IPT-OX-10
• Status: Completed
• Phase: N/A
• First received: May 30, 2017
• Last updated: May 31, 2017
• Start date: October 20, 2010
• Est. completion date: May 16, 2014

Study information

• Verified date: May 2017
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 16, 2014
• Est. primary completion date: May 16, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Insulin Pump Therapy in Treating Diabetic Nephropathy
• Kidney Diseases

Intervention

Device:
• Insulin pump
Blood glucose management device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The change of 3-nitrotyrosine (3-NT)	The change of 3-nitrotyrosine (3-NT) in serum	2 weeks
Secondary	The change of glutathione (GSH)	The change of glutathione (GSH) in serum	2 weeks
Secondary	The change of superoxide dismutase (SOD)	The change of superoxide dismutase (SOD) in serum	2 weeks