Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)
Overview
- Phase
- Phase 3
- Intervention
- CIIIT
- Conditions
- Diabetic Nephropathy
- Sponsor
- Joslin Diabetes Center
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Rate of loss of creatinine clearance
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Treatment
Intervention: three one-hour courses of pulsed intravenous insulin infusion on a single day per week in addition to standard subcutaneous insulin.
Intervention: CIIIT
Outcomes
Primary Outcomes
Rate of loss of creatinine clearance
Time Frame: 18 months
Secondary Outcomes
- Quality of life assessment(12 to 18 months)
- Change in cardiac autonomic function(12 to18 months)
- Change in retinal photos(12 to 18 months)
- Change in cardiac function(12 to 18 months)