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Effects of Pulsatile IV Insulin Delivery on Diabetic Retinopathy in Patients With Types 1 and 2 Diabetes Mellitus

NCT00287651 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-08-10

No results posted yet for this study

Summary

Diabetic Retinopathy is the leading cause of blindness in the world. Previous studies have documented beneficial effects of physiologic administration of pulsatile insulin on a variety of diabetic complications such as nephropathy, hypertension, glycemic control, etc. Similar pathogenetic mechanisms have been postulated for diabetic retinal disease. This study examines the effect of pulsatile insulin on patients with varying stages of diabetic retinal disease.

Conditions

  • Diabetes Mellitus, With Complications

Interventions

PROCEDURE

Pulsatile IV Insulin

Intravenous Insulin is provided in a pulsed manner based upon weekly physician orders the amount of insulin provided is dependent on patients level of insulin resistance.

PROCEDURE

Effects of Pulsatile IV Insulin on Diabetic Retinopathy

Control Patients are not given pulsatile intravenous insulin therapy during the study.

PROCEDURE

Effects of Pulsatile IV Insulin on Diabetic Retinopathy

Intravenous Insulin is provided in a pulsed manner based upon weekly physician orders the amount of insulin provided is dependent on patients level of insulin resistance.

Sponsors & Collaborators

  • Advanced Diabetes Treatment Centers

    collaborator OTHER

  • Global Infusions

    collaborator INDUSTRY

  • Florida Atlantic University

    lead OTHER

Principal Investigators

  • Betty Tuller, Ph.D · Florida Atlantic University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00287651 on ClinicalTrials.gov