- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03174821
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
- 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.)
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:
|
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPT-OX-10
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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