Back to resultsEffect Insulin Pump Therapy to Patients With Diabetic Nephropathy
Primary Purpose
Insulin Pump Therapy in Treating Diabetic Nephropathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Insulin pump
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Pump Therapy in Treating Diabetic Nephropathy focused on measuring Diabetic nephropathy, Insulin pump intensive therapy
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.)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Insulin pump therapy
Normal control
Arm Description
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.
The subjects were asked to maintain normal diet and lifestyle until the end of the observation period.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
The change of 3-nitrotyrosine (3-NT)
The change of 3-nitrotyrosine (3-NT) in serum
The change of glutathione (GSH)
The change of glutathione (GSH) in serum
The change of superoxide dismutase (SOD)
The change of superoxide dismutase (SOD) in serum
Full Information
NCT ID
NCT03174821
First Posted
May 30, 2017
Last Updated
May 31, 2017
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03174821
Brief Title
Effect Insulin Pump Therapy to Patients With Diabetic Nephropathy
Official Title
The Impact of Insulin Pump Therapy to Oxidative Stress in Patients With Diabetic Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 20, 2010 (Actual)
Primary Completion Date
May 16, 2014 (Actual)
Study Completion Date
May 16, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Pump Therapy in Treating Diabetic Nephropathy
Keywords
Diabetic nephropathy, Insulin pump intensive therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Normal group (NC) and Type 2 diabetic (DM) group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin pump therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal control
Arm Type
No Intervention
Arm Description
The subjects were asked to maintain normal diet and lifestyle until the end of the observation period.
Intervention Type
Device
Intervention Name(s)
Insulin pump
Other Intervention Name(s)
Diabetes insulin pump
Intervention Description
Blood glucose management device
Primary Outcome Measure Information:
Title
The change of 8-hydroxy-deoxyguanosine (8-OHdG)
Description
The change of 8-hydroxy-deoxyguanosine (8-OHdG) in serum of diabetic patients with diabetic nephropathy (DN)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
The change of 3-nitrotyrosine (3-NT)
Description
The change of 3-nitrotyrosine (3-NT) in serum
Time Frame
2 weeks
Title
The change of glutathione (GSH)
Description
The change of glutathione (GSH) in serum
Time Frame
2 weeks
Title
The change of superoxide dismutase (SOD)
Description
The change of superoxide dismutase (SOD) in serum
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Liu
Organizational Affiliation
Center for Drug Evaluation, China food and Drug Administration
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The individual participant data (IPD) was not allowed to use outside this research.
Citations:
PubMed Identifier
29433562
Citation
Zhang XG, Zhang YQ, Cheng QP, Cao Y, Sun JM, Lv XF. The impact of insulin pump therapy to oxidative stress in patients with diabetic nephropathy. Eur J Med Res. 2018 Feb 12;23(1):7. doi: 10.1186/s40001-018-0304-2.
Results Reference
derived
Learn more about this trial
Effect Insulin Pump Therapy to Patients With Diabetic Nephropathy
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