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

Phase 3

Completed

• Conditions: Diabetic Nephropathy; Diabetic Retinopathy
• Interventions: Drug: CIIIT

• Registration Number: NCT00594152
• Lead Sponsor: Joslin Diabetes Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 1993-01
• Study Completion: 1995-01
• Status Verified: 2008-01
• Study First Submitted: 2008-01-03
• Study First Submitted QC: 2008-01-14
• Last Update Submitted: 2008-01-14
• Study First Posted: 2008-01-15
• Last Update Posted: 2008-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of loss of creatinine clearance	18 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States