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

January 14, 2008 updated by: Joslin Diabetes Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of loss of creatinine clearance
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life assessment
Time Frame: 12 to 18 months
12 to 18 months
Change in cardiac autonomic function
Time Frame: 12 to18 months
12 to18 months
Change in retinal photos
Time Frame: 12 to 18 months
12 to 18 months
Change in cardiac function
Time Frame: 12 to 18 months
12 to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joslin Diabetes Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1993

Study Completion (Actual)

January 1, 1995

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Estimate)

January 15, 2008

Last Update Submitted That Met QC Criteria

January 14, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHS#92-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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