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

This study has been completed.
Sponsor:
Information provided by:
Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT00594152
First received: January 3, 2008
Last updated: January 14, 2008
Last verified: January 2008
History of Changes
  Purpose

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 Intervention Phase
Diabetic Nephropathy
Diabetic Retinopathy
 Drug: CIIIT
 Phase 3

Study Type: Interventional
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • Rate of loss of creatinine clearance [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 71
Study Start Date: January 1993
Study Completion Date: January 1995
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594152

Locations
United States, Massachusetts
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: John D'Elia, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00594152     History of Changes
Other Study ID Numbers: CHS#92-16
Study First Received: January 3, 2008
Last Updated: January 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Joslin Diabetes Center:
Diabetic autonomic neuropathy

Additional relevant MeSH terms:
Diabetic Nephropathies
Diabetic Retinopathy
Kidney Diseases
Retinal Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
 Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013