NCT03174821

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2014

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
Last Updated

June 5, 2017

Status Verified

May 1, 2017

Enrollment Period

3.6 years

First QC Date

May 30, 2017

Last Update Submit

May 31, 2017

Conditions

Insulin Pump Therapy in Treating Diabetic Nephropathy

Keywords

Diabetic nephropathyInsulin pump intensive therapy

Outcome Measures

Primary Outcomes (1)

  • 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)

    2 weeks

Secondary Outcomes (3)

  • The change of 3-nitrotyrosine (3-NT)

    2 weeks

  • The change of glutathione (GSH)

    2 weeks

  • The change of superoxide dismutase (SOD)

    2 weeks

Study Arms (2)

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.

Device: Insulin pump

Normal control

NO INTERVENTION

The subjects were asked to maintain normal diet and lifestyle until the end of the observation period.

Interventions

Insulin pumpDEVICE

Blood glucose management device

Also known as: Diabetes insulin pump
Insulin pump therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic patients with fasting plasma glucose (FPG) ≥10mmol/l and/or 2 hours' plasma glucose (2hPG) ≥15mmol/l.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29433562DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Insulin Infusion Systems

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Delivery SystemsDrug TherapyTherapeuticsInfusion PumpsEquipment and SuppliesArtificial OrgansSurgical Equipment

Study Officials

  • Min Liu

    Center for Drug Evaluation, China food and Drug Administration

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Normal group (NC) and Type 2 diabetic (DM) group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 5, 2017

Study Start

October 20, 2010

Primary Completion

May 16, 2014

Study Completion

May 16, 2014

Last Updated

June 5, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

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