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

This study has been terminated.
(Administrative)
Sponsor:
Collaborators:
Advanced Diabetes Treatment Centers
Global Infusions
Information provided by:
Florida Atlantic University
ClinicalTrials.gov Identifier:
NCT00228904
First received: September 27, 2005
Last updated: August 25, 2009
Last verified: August 2009
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Pulsatile IV Insulin Delivery on Peripheral Diabetic Neuropathy

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2005
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
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
Active Comparator: 2
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
Other Name: humalog, humulin, novolog

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
Florida Atlantic University Center for Complex Systems and Brain Sciences
Boca Raton, Florida, United States, 33431
Sponsors and Collaborators
Florida Atlantic University
Advanced Diabetes Treatment Centers
Global Infusions
Investigators
Principal Investigator: Betty Tuller, PhD Florida Atlantic University
  More Information

Publications:
Responsible Party: Betty Tuller PhD Professor of Complex Systems and Brain Sciences, Florida Atlantic University
ClinicalTrials.gov Identifier: NCT00228904     History of Changes
Other Study ID Numbers: H09-66 NEU2, MH42900 and MH01386
Study First Received: September 27, 2005
Last Updated: August 25, 2009
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

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014