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

Study Overview
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Brief Summary
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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).

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

Conditions
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Diabetic Nephropathy, Diabetic Retinopathy

Intervention / Treatment
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* Drug: CIIIT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1Control<br>Standard treatment of type 1 diabetes mellitus with 3-4 subcutaneous injections of insulin daily | |
| Experimental: Treatment<br>Intervention: three one-hour courses of pulsed intravenous insulin infusion on a single day per week in addition to standard subcutaneous insulin. | Drug: CIIIT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of loss of creatinine clearance |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic autonomic neuropathy