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

NCT ID: NCT00594152

Last Updated: 2008-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1993-01-31
• Study Completion Date: 1995-01-31

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).

Conditions

Diabetic Nephropathy; Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment

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

Group Type: EXPERIMENTAL

CIIIT

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joslin Diabetes Center

OTHER

Sponsor Role: lead

Responsible Party

Joslin Diabetes Center

Principal Investigators

John A D'Elia, MD

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Locations

Joslin Diabetes Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11092517 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20189608 (View on PubMed)

Other Identifiers

CHS#92-16

Identifier Type: -

Identifier Source: org_study_id