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

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ClinicalTrials.gov Identifier: NCT00594152
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : January 15, 2008
Sponsor:
Information provided by:
Joslin Diabetes Center

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
Diabetic Nephropathy Diabetic Retinopathy Drug: CIIIT Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : January 1993
Actual Study Completion Date : January 1995

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Rate of loss of creatinine clearance [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Quality of life assessment [ Time Frame: 12 to 18 months ]
  2. Change in cardiac autonomic function [ Time Frame: 12 to18 months ]
  3. Change in retinal photos [ Time Frame: 12 to 18 months ]
  4. Change in cardiac function [ Time Frame: 12 to 18 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594152


Locations
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United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Investigators
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Principal Investigator: John A D'Elia, MD Joslin Diabetes Center

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John D'Elia, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00594152     History of Changes
Other Study ID Numbers: CHS#92-16
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008
Keywords provided by Joslin Diabetes Center:
Diabetic autonomic neuropathy
Additional relevant MeSH terms:
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Diabetic Retinopathy
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs