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Clinical Trials/NCT03174821
NCT03174821
Completed
Not Applicable

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

Chinese PLA General Hospital0 sites160 target enrollmentOctober 20, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insulin Pump Therapy in Treating Diabetic Nephropathy
Sponsor
Chinese PLA General Hospital
Enrollment
160
Primary Endpoint
The change of 8-hydroxy-deoxyguanosine (8-OHdG)
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2010
End Date
May 16, 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chinese PLA General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Xiaofeng Lv

Principal investigator

Chinese PLA General Hospital

Eligibility Criteria

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.)

Outcomes

Primary Outcomes

The change of 8-hydroxy-deoxyguanosine (8-OHdG)

Time Frame: 2 weeks

The change of 8-hydroxy-deoxyguanosine (8-OHdG) in serum of diabetic patients with diabetic nephropathy (DN)

Secondary Outcomes

  • The change of glutathione (GSH)(2 weeks)
  • The change of 3-nitrotyrosine (3-NT)(2 weeks)
  • The change of superoxide dismutase (SOD)(2 weeks)

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