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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594152
• Other study ID #: CHS#92-16
• Status: Completed
• Phase: Phase 3
• First received: January 3, 2008
• Last updated: January 14, 2008
• Start date: January 1993
• Est. completion date: January 1995

Study information

• Verified date: January 2008
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 1995
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Diabetic Retinopathy

Intervention

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.

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dailey GE, Boden GH, Creech RH, Johnson DG, Gleason RE, Kennedy FP, Weinrauch LA, Weir M, D'Elia JA. Effects of pulsatile intravenous insulin therapy on the progression of diabetic nephropathy. Metabolism. 2000 Nov;49(11):1491-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of loss of creatinine clearance		18 months	No
Secondary	Quality of life assessment		12 to 18 months	No
Secondary	Change in cardiac autonomic function		12 to18 months	No
Secondary	Change in retinal photos		12 to 18 months	No
Secondary	Change in cardiac function		12 to 18 months	No