Effect Insulin Pump Therapy to Patients With Diabetic Nephropathy

Chinese PLA General Hospital (301 Hospital)

Status: Completed

Conditions: Insulin Pump Therapy in Treating Diabetic Nephropathy

Treatments: Device: Insulin pump

Study type: Interventional

Funder types: Other

Identifiers

NCT03174821

IPT-OX-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

Insulin pump therapy

Experimental group

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.

Treatment:

Device: Insulin pump

Normal control

No Intervention group

Description:

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