Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
No Intervention: 1Control Standard treatment of type 1 diabetes mellitus with 3-4 subcutaneous injections of insulin daily |
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Experimental: Treatment Intervention: three one-hour courses of pulsed intravenous insulin infusion on a single day per week in addition to standard subcutaneous insulin. |
Drug: CIIIT
The intravenous infusion group received three one-hour courses of pulsed intravenous insulin infusion on a single day per week in addition to subcutaneous insulin.
|
Outcome Measures
Primary Outcome Measures
- Rate of loss of creatinine clearance [18 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Joslin Diabetes Center | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Joslin Diabetes Center
Investigators
- Principal Investigator: John A D'Elia, MD, Joslin Diabetes Center
Study Documents (Full-Text)
None provided.More Information
Publications
- CHS#92-16