Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)

Joslin Diabetes Center

Status and phase: Completed; Phase 3

Conditions: Diabetic Nephropathy; Diabetic Retinopathy

Treatments: Drug: CIIIT

Study type: Interventional

Funder types: Other

Identifiers

NCT00594152

CHS#92-16

Details and patient eligibility

About

Investigators with the goal of optimizing glycemic and blood pressure control saw type 1 diabetic patients weekly. A control group received 3-4 subcutaneous insulin injections per day; an intravenous insulin pulsed infusion group received, in addition, three one hour infusions in a pulsatile fashion over one eight hour period each week. Patients were followed for 12 months with periodic testing of renal function by repeated blood and urinary analyses; diabetes control by blood testing and diabetes impact measurement score; cardiac and autonomic function by echocardiography, 24 hour electrocardiographic testing; and visual changes with repeated fundus photography. The study hypothesis was that correction of respiratory quotient would correct the defect leading to microvascular complications of diabetes (Type 1).

Enrollment: 71 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetics with proteinuria willing to be seen weekly for the evaluation of renal function

Exclusion criteria

• Associated active medical diseases that would not permit evaluation of stable renal disease over 18 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

1Control

No Intervention group

Description:

Standard treatment of type 1 diabetes mellitus with 3-4 subcutaneous injections of insulin daily

Treatment

Experimental group

Description:

Intervention: three one-hour courses of pulsed intravenous insulin infusion on a single day per week in addition to standard subcutaneous insulin.

Treatment:

Drug: CIIIT