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Completed

NCT Number: NCT00594152

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

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).

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Key information

Conditions

Diabetic Nephropathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Nephropathies Diabetic Neuropathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Retinal Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CIIIT

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.

Primary outcomes

  1. Rate of loss of creatinine clearance

    Time frame: 18 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Registry information

Important dates

Study start
1993
Study completion
1995
First posted
Jan 15, 2008
Registry last updated
Jan 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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