Skip to main content
OpenTrials
Completed

NCT Number: NCT03174821

Effect Insulin Pump Therapy to Patients With Diabetic Nephropathy

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Insulin pump

Device

Blood glucose management device

Other names: Diabetes insulin pump

Primary outcomes

  1. 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

  1. The change of 3-nitrotyrosine (3-NT)

    Time frame: 2 weeks

    The change of 3-nitrotyrosine (3-NT) in serum

  2. The change of glutathione (GSH)

    Time frame: 2 weeks

    The change of glutathione (GSH) in serum

  3. The change of superoxide dismutase (SOD)

    Time frame: 2 weeks

    The change of superoxide dismutase (SOD) in serum

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 5, 2017
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.