Effect Insulin Pump Therapy to Patients With Diabetic Nephropathy

May 31, 2017 updated by: Xiaofeng Lv, Chinese PLA General Hospital

The Impact of Insulin Pump Therapy to Oxidative Stress in 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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin pump therapy
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.
Blood glucose management device
Other Names:
  • Diabetes insulin pump
No Intervention: Normal control
The subjects were asked to maintain normal diet and lifestyle until the end of the observation period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of 3-nitrotyrosine (3-NT)
Time Frame: 2 weeks
The change of 3-nitrotyrosine (3-NT) in serum
2 weeks
The change of glutathione (GSH)
Time Frame: 2 weeks
The change of glutathione (GSH) in serum
2 weeks
The change of superoxide dismutase (SOD)
Time Frame: 2 weeks
The change of superoxide dismutase (SOD) in serum
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Min Liu, Center for Drug Evaluation, China food and Drug Administration

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2010

Primary Completion (Actual)

May 16, 2014

Study Completion (Actual)

May 16, 2014

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

May 31, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

June 5, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data (IPD) was not allowed to use outside this research.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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