Trial | NCT00594152  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    71
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).
Study Started
Jan 31
1993
Study Completion
Jan 31
1995
Last Update
Jan 15
2008
Estimate

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.

1Control No Intervention

Standard treatment of type 1 diabetes mellitus with 3-4 subcutaneous injections of insulin daily

Treatment Experimental

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

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
No Results Posted