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

NCT00228891 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 152

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 in 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 insulin delivery on diabetic neuropathy.

Conditions

  • Diabetes Mellitus, With Complications

Interventions

PROCEDURE

Effect of Pulsatile IV insulin on diabetic neuropathy

Control patients with diagnosed diabetic neuropathy will have objective testing at baseline and every six months to compare and measure results to patients receiving pulsatile intravenous insulin therapy.

PROCEDURE

Effect of Pulsatile IV Insulin on diabetic neuropathy

Patients diagnosed with diabetic neuropathy will be treated with pulsatile intravenous insulin on a weekly basis. Patient's Endocrinologist will determine the dosage of intravenous insulin to be given each week based upon the patient's response and insulin resistance.

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
2004-02-29
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 NCT00228891 on ClinicalTrials.gov