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

Sponsor
Joslin Diabetes Center (Other)
Overall Status
Completed
CT.gov ID
NCT00594152
Collaborator
(none)
71
1
2
24
3

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
71 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)
Study Start Date :
Jan 1, 1993
Actual Study Completion Date :
Jan 1, 1995

Arms and Interventions

Arm Intervention/Treatment
No Intervention: 1Control

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

Experimental: Treatment

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

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.

Outcome Measures

Primary Outcome Measures

  1. Rate of loss of creatinine clearance [18 months]

Secondary Outcome Measures

  1. Quality of life assessment [12 to 18 months]

  2. Change in cardiac autonomic function [12 to18 months]

  3. Change in retinal photos [12 to 18 months]

  4. Change in cardiac function [12 to 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Joslin Diabetes Center Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Joslin Diabetes Center

Investigators

  • Principal Investigator: John A D'Elia, MD, Joslin Diabetes Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00594152
Other Study ID Numbers:
  • CHS#92-16
First Posted:
Jan 15, 2008
Last Update Posted:
Jan 15, 2008
Last Verified:
Jan 1, 2008
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 15, 2008