Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)|
- Rate of loss of creatinine clearance [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Quality of life assessment [ Time Frame: 12 to 18 months ] [ Designated as safety issue: No ]
- Change in cardiac autonomic function [ Time Frame: 12 to18 months ] [ Designated as safety issue: No ]
- Change in retinal photos [ Time Frame: 12 to 18 months ] [ Designated as safety issue: No ]
- Change in cardiac function [ Time Frame: 12 to 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 1993|
|Study Completion Date:||January 1995|
No Intervention: 1Control
Standard treatment of type 1 diabetes mellitus with 3-4 subcutaneous injections of insulin daily
Intervention: three one-hour courses of pulsed intravenous insulin infusion on a single day per week in addition to standard subcutaneous insulin.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594152
|United States, Massachusetts|
|Joslin Diabetes Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||John A D'Elia, MD||Joslin Diabetes Center|