Insulin Pump Therapy in Treating Diabetic NephropathyNCT03174821
Effect Insulin Pump Therapy to Patients With Diabetic Nephropathy
A study testing Insulin pump in people with Insulin Pump Therapy in Treating Diabetic Nephropathy, run by Chinese PLA General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Pump Therapy in Treating Diabetic Nephropathy
- What is being tested?
- Insulin pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2010to 16 May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diabetic patients with fasting plasma glucose (FPG) ≥10mmol/l and/or 2 hours' plasma glucose (2hPG) ≥15mmol/l.
Who cannot join
- 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.)
About this study
Official title: 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.
Read the 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.
- Being tested
- Insulin pump
- Keywords
- Diabetic nephropathy, Insulin pump intensive therapy
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin pumpDevice
Also called Diabetes insulin pump
Blood glucose management device
| Study group | Role | What they receive |
|---|---|---|
| Insulin pump therapy | Experimental | 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. Receives: Device: Insulin pump |
| Normal control | No intervention | The subjects were asked to maintain normal diet and lifestyle until the end of the observation period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 weeks
Secondary outcomes (3)
The change of 3-nitrotyrosine (3-NT)
The change of 3-nitrotyrosine (3-NT) in serum
Measured: 2 weeks
The change of glutathione (GSH)
The change of glutathione (GSH) in serum
Measured: 2 weeks
The change of superoxide dismutase (SOD)
The change of superoxide dismutase (SOD) in serum
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start20 Oct 2010
- Primary completion16 May 2014
- Study completion16 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin Pump Therapy in Treating Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Normal group (NC) and Type 2 diabetic (DM) group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofeng Lv, Chinese PLA General Hospital
- Investigators
- Min Liu, Study chair, Center for Drug Evaluation, China food and Drug Administration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174821
- Sponsor's protocol ID
- IPT-OX-10
- Status last verified
- May 2017
- First submitted
- 30 May 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) was not allowed to use outside this research.
Publications
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.
PubMed 29433562
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Insulin Pump Therapy to Oxidative Stress in Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT03174821
- Acronym / sponsor ID
- IPT-OX-10
- Keywords
- Diabetic nephropathy, Insulin pump intensive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 20 Oct 2010 (actual)
- Primary completion
- 16 May 2014 (actual)
- Study completion
- 16 May 2014 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Normal group (NC) and Type 2 diabetic (DM) group
| Arm | Type | Receives |
|---|---|---|
| Insulin pump therapy | Experimental | Device: Insulin pumpThe 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. |
| Normal control | No intervention | –The subjects were asked to maintain normal diet and lifestyle until the end of the observation period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patients with fasting plasma glucose (FPG) ≥10mmol/l and/or 2 hours' plasma glucose (2hPG) ≥15mmol/l.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin pumpAlso: Diabetes insulin pumpBlood glucose management device | Device | Insulin pump therapy |
Primary outcome
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)
3 secondary outcomes
The change of 3-nitrotyrosine (3-NT)
Time frame: 2 weeks
The change of glutathione (GSH)
Time frame: 2 weeks
The change of superoxide dismutase (SOD)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Derived from this study: PubMed 29433562Zhang 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.
- Individual participant dataSharing planned: No. The individual participant data (IPD) was not allowed to use outside this research.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Liu study chair
Center for Drug Evaluation, China food and Drug Administration
Questions about this trial
What is this clinical trial studying?
A study testing Insulin pump in people with Insulin Pump Therapy in Treating Diabetic Nephropathy, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of 8-hydroxy-deoxyguanosine (8-OHdG) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03174821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.