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Effects of Pulsatile Intravenous Insulin Delivery on Diabetic Neuropathy in pATIENTS (Pts) With Type 1 and Type 2 Diabetes

NCT00228904 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2016-08-10

No results posted yet for this study

Summary

Diabetic neuropathy is a progressive complication causing serious problems in 25-40% of diabetic patients. Anecdotal reports have indicated improvement with pulsatile IV insulin therapy in affected patients otherwise resistant to all conventional therapies. Significant complications produce painful peripheral dysesthesias, loss of sensation and gastroparesis. This study is designed to test the effectiveness of pulsatile IV insulin therapy on diabetic neuropathy.

Conditions

  • Diabetic Neuropathy

Interventions

PROCEDURE

Placebo

Control patients diagnosed with diabetic neuropathy are tested at baseline and every six months thereafter to compare to patients treated with pulsatile intravenous insulin therapy

PROCEDURE

Pulsatile IV insulin delivery (humalog, humulin, novolog)

Patients with diagnosed diabetic neuropathy have objective testing and questionnaires performed at baseline and every six months thereafter to evaluate and analyze progress of diabetic neuropathy after start of treatment of pulsatile intravenous insulin therapy

Sponsors & Collaborators

  • Advanced Diabetes Treatment Centers

    collaborator OTHER

  • Global Infusions

    collaborator INDUSTRY

  • Florida Atlantic University

    lead OTHER

Principal Investigators

  • Betty Tuller, PhD · Florida Atlantic University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2011-05-31
Completion
2011-10-31

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 NCT00228904 on ClinicalTrials.gov