Back to resultsAnti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)
Primary Purpose
Diabetic Nephropathy, Diabetic Retinopathy
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CIIIT
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetic autonomic neuropathy
Eligibility 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
Sites / Locations
- Joslin Diabetes Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1Control
Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
Rate of loss of creatinine clearance
Secondary Outcome Measures
Quality of life assessment
Change in cardiac autonomic function
Change in retinal photos
Change in cardiac function
Full Information
NCT ID
NCT00594152
First Posted
January 3, 2008
Last Updated
January 14, 2008
Sponsor
Joslin Diabetes Center
1. Study Identification
Unique Protocol Identification Number
NCT00594152
Brief Title
Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)
Official Title
Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 1995 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Joslin Diabetes Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy, Diabetic Retinopathy
Keywords
Diabetic autonomic neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1Control
Arm Type
No Intervention
Arm Description
Standard treatment of type 1 diabetes mellitus with 3-4 subcutaneous injections of insulin daily
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Intervention: three one-hour courses of pulsed intravenous insulin infusion on a single day per week in addition to standard subcutaneous insulin.
Intervention Type
Drug
Intervention Name(s)
CIIIT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of loss of creatinine clearance
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Quality of life assessment
Time Frame
12 to 18 months
Title
Change in cardiac autonomic function
Time Frame
12 to18 months
Title
Change in retinal photos
Time Frame
12 to 18 months
Title
Change in cardiac function
Time Frame
12 to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A D'Elia, MD
Organizational Affiliation
Joslin Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11092517
Citation
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. doi: 10.1053/meta.2000.17700.
Results Reference
background
PubMed Identifier
20189608
Citation
Weinrauch LA, Sun J, Gleason RE, Boden GH, Creech RH, Dailey G, Kennedy FP, Weir MR, D'Elia JA. Pulsatile intermittent intravenous insulin therapy for attenuation of retinopathy and nephropathy in type 1 diabetes mellitus. Metabolism. 2010 Oct;59(10):1429-34. doi: 10.1016/j.metabol.2010.01.004. Epub 2010 Mar 1.
Results Reference
derived
Learn more about this trial
Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)
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