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

NCT00228891 | Terminated Phase 2 DMC

• 2 other identifiers: H09-66 NEU1MH42900 and MH01386
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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 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

Keywords

Pulsatile intravenous insulin; Oral carbohydrate loading; Respiratory Quotients; Hypoglycemia; Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• Measure the stabilization or reduction of the decline of diabetic neuropathy by pt questionnaires and diagnostic tests

  Measure the stabilization and reduction of complications associated with diabetic neuropathy

Study Arms (2)

2

ACTIVE COMPARATOR

Patients with diagnosed diabetic neuropathy will receive objective baseline testing and follow up testing every six months after the start of Pulsatile intravenous insulin therapy to monitor and assess diabetic neuropathy.

Procedure: Effect of Pulsatile IV Insulin on diabetic neuropathy

1

PLACEBO COMPARATOR

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

Procedure: Effect of Pulsatile IV insulin on diabetic neuropathy

Interventions

Effect of Pulsatile IV Insulin on diabetic neuropathy PROCEDURE

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.

1

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The researchers will include 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
• Taking oral agents and/or insulin for diabetic control
• Under an Endocrinologists supervision for their diabetes management. Endocrinologist must assess and approve patient for participation in this study
• Ability to swallow without difficulty
• 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
• Positive HIV
• Inability to breathe into machine for respiratory quotients

Sponsors & Collaborators

• Florida Atlantic University: lead
• Advanced Diabetes Treatment Centers: collaborator
• Global Infusions: collaborator

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: 16108870 BACKGROUND

• 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: 16150538 BACKGROUND

• 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: 15673800 BACKGROUND

• 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: 9704317 BACKGROUND

• 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: 15927394 BACKGROUND

MeSH Terms

Conditions

Diabetes Complications; Hypoglycemia; Diabetic Neuropathies

Interventions

Insulin, Regular, Human; Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Insulin; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Betty Tuller, PhD

  Florida Atlantic University

  PRINCIPAL INVESTIGATOR

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, 2004
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

US (1)