Effects of Pulsatile Intravenous (IV) Insulin Delivery on Diabetic Neuropathy in Patients With Type 1 and Type 2 Diabetes Mellitus - Full Text View

Sponsors and Collaborators:	Florida Atlantic University Advanced Diabetes Treatment Centers
Information provided by:	Florida Atlantic University
ClinicalTrials.gov Identifier:	NCT00228904

Purpose

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.

Condition	Intervention	Phase
Diabetic Neuropathy	Procedure: Placebo Procedure: Pulsatile IV insulin delivery (humalog, humulin, novolog)	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Pulsatile IV Insulin Delivery on Peripheral Diabetic Neuropathy

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetic Nerve Problems

Drug Information available for: Insulin Insulin aspart Insulin lispro

U.S. FDA Resources

Further study details as provided by Florida Atlantic University:

Primary Outcome Measures:

To evaluate objective testing performed including nerve conduction velocity in diabetic patients treated with pulsatile intravenous insulin therapy [ Time Frame: at baseline and every six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To obtain patient questionnaires and perform objective testing to analyze, compare and measure progress [ Time Frame: prior to start of pulsatile intravenous insulin therapy and every six months thereafter ]

Estimated Enrollment:	400
Study Start Date:	February 2005
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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
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) 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

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Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Up to 200 patients both male and female between the ages of 21 and 85 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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228904

Contacts

Contact: Paul Mahowald, BA	561 314 2540	paul@amtcusa.com
Contact: Dawn Villacci, BA	561 314 2544	dvillacci@amtcusa.com

Locations

United States, Florida
Florida Atlantic University Center for Complex Systems and Brain Sciences	Recruiting
Boca Raton, Florida, United States, 33431
Contact: Betty Tuller, Ph.D 561-297-2227 tuller@walt.ccs.fau.edu
Principal Investigator: Betty Tuller, Ph.D

Sponsors and Collaborators

Florida Atlantic University

Advanced Diabetes Treatment Centers

Investigators

Principal Investigator:

Betty Tuller, PhD

Florida Atlantic University

More Information

Publications:

Gill G, Moulik P. Mortality and diabetic neuropathy. Diabet Med. 2005 Sep;22(9):1289. No abstract available.

Moghtaderi A, Bakhshipour A, Rashidi H. Validation of Michigan neuropathy screening instrument for diabetic peripheral neuropathy. Clin Neurol Neurosurg. 2005 Sep 5; [Epub ahead of print]

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.

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.

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.

Responsible Party:	Florida Atlantic University ( Betty Tuller PhD Professor of Complex Systems and Brain Sciences )
Study ID Numbers:	H07-06 NEU2, MH42900 and MH01386
Study First Received:	September 27, 2005
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00228904 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Florida Atlantic University:

Pulsatile intravenous insulin
Oral carbohydrate loading
Respiratory Quotients

Hypoglycemia
Diabetic Neuropathy
Diabetes Mellitus, with complications

Study placed in the following topic categories:

Metabolic Diseases
Diabetic Neuropathies
Diabetes Mellitus
Insulin LISPRO
Endocrine System Diseases
Hypoglycemia
Insulin
Hypoglycemic Agents

Neuromuscular Diseases
Peripheral Nervous System Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Diabetes Complications

Additional relevant MeSH terms:

Metabolic Diseases
Diabetic Neuropathies
Physiological Effects of Drugs
Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases
Insulin LISPRO
Pharmacologic Actions

Insulin
Hypoglycemic Agents
Neuromuscular Diseases
Peripheral Nervous System Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Glucose Metabolism Disorders
Diabetes Complications

ClinicalTrials.gov processed this record on July 02, 2009