NCT00228904

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

6.2 years

First QC Date

September 27, 2005

Last Update Submit

August 8, 2016

Conditions

Diabetic Neuropathy

Keywords

Pulsatile intravenous insulinOral carbohydrate loadingRespiratory QuotientsHypoglycemiaDiabetic NeuropathyDiabetes Mellitus, with complications

Outcome Measures

Primary Outcomes (1)

  • To evaluate objective testing performed including nerve conduction velocity in diabetic patients treated with pulsatile intravenous insulin therapy

    at baseline and every six months

Secondary Outcomes (1)

  • To obtain patient questionnaires and perform objective testing to analyze, compare and measure progress

    prior to start of pulsatile intravenous insulin therapy and every six months thereafter

Study Arms (2)

1

PLACEBO COMPARATOR

Control patients with diagnosed diabetic neuropathy will receive baseline testing and testing every six months thereafter to compare and analyze results with patients treated with pulsatile intravenous insulin therapy.

Procedure: Placebo

2

ACTIVE COMPARATOR

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 the start of pulsatile intravenous insulin therapy.

Procedure: Pulsatile IV insulin delivery (humalog, humulin, novolog)

Interventions

PlaceboPROCEDURE

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

1
Pulsatile IV insulin delivery (humalog, humulin, novolog)PROCEDURE

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

Also known as: humalog, humulin, novolog
2

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Up to 500 patients both male and female between the ages of 20 and 90 diagnosed with type 1 or type 2 diabetes mellitus.
  • All patients were diagnosed by their endocrinologists as having diabetic neuropathy.
  • All patients had failed conventional treatment for diabetic neuropathy.
  • All patients are taking oral agents and/or insulin for diabetic control.
  • All patients are under an endocrinologist's supervision for their diabetes management.
  • Endocrinologist must assess and approve patient for participation in this study.
  • All patients must demonstrate the ability to swallow without difficulty and the ability to commit to the weekly time requirements associated with the study.

You may not qualify if:

  • Other causes of complications not related to diabetes
  • Lack of intravenous access
  • Pregnancy
  • Alcohol abuse, drug addiction or the use of illegal drugs
  • HIV positive
  • Inability to breathe into machine for respiratory quotients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Atlantic University Center for Complex Systems and Brain Sciences

Boca Raton, Florida, 33431, United States

Location

Related Publications (5)

  • Gill G, Moulik P. Mortality and diabetic neuropathy. Diabet Med. 2005 Sep;22(9):1289. doi: 10.1111/j.1464-5491.2005.01729.x. No abstract available.

    PMID: 16108870BACKGROUND

  • Moghtaderi A, Bakhshipour A, Rashidi H. Validation of Michigan neuropathy screening instrument for diabetic peripheral neuropathy. Clin Neurol Neurosurg. 2006 Jul;108(5):477-81. doi: 10.1016/j.clineuro.2005.08.003. Epub 2005 Sep 16.

    PMID: 16150538BACKGROUND

  • Tesfaye S, Chaturvedi N, Eaton SE, Ward JD, Manes C, Ionescu-Tirgoviste C, Witte DR, Fuller JH; EURODIAB Prospective Complications Study Group. Vascular risk factors and diabetic neuropathy. N Engl J Med. 2005 Jan 27;352(4):341-50. doi: 10.1056/NEJMoa032782.

    PMID: 15673800BACKGROUND

  • Potter PJ, Maryniak O, Yaworski R, Jones IC. Incidence of peripheral neuropathy in the contralateral limb of persons with unilateral amputation due to diabetes. J Rehabil Res Dev. 1998 Jul;35(3):335-9.

    PMID: 9704317BACKGROUND

  • Goldstein DJ, Lu Y, Detke MJ, Lee TC, Iyengar S. Duloxetine vs. placebo in patients with painful diabetic neuropathy. Pain. 2005 Jul;116(1-2):109-18. doi: 10.1016/j.pain.2005.03.029.

    PMID: 15927394BACKGROUND

MeSH Terms

Conditions

Diabetic NeuropathiesHypoglycemiaDiabetes Complications

Interventions

Insulin LisproInsulin, Regular, HumanInsulin Aspart

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulinProinsulin

Study Officials

  • Betty Tuller, PhD

    Florida Atlantic University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

February 1, 2005

Primary Completion

May 1, 2011

Study Completion

October 1, 2011

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations

US(1)