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Effect of Pulsatile IV Insulin on Circulating Risk Markers of Vascular and Metabolic Complications in Pts With Diabetes

This study has been terminated.
(Administrative)
Sponsor:
Collaborator:
Advanced Diabetes Treatment Centers
Information provided by:
Florida Atlantic University
ClinicalTrials.gov Identifier:
NCT00361907
First received: April 13, 2006
Last updated: August 25, 2009
Last verified: August 2009
History of Changes
  Purpose

The purpose of this study is to determine the effect of Pulsatile Intravenous Insulin therapy on circulating blood markers. These blood markers are selected due to their correlation to and possible pathogenetic roles in vascular compromise and inflammatory malfunction in diabetic patients.


Condition Intervention Phase
Diabetes Mellitus
 Procedure: Effect of Pulsatile IV insulin on diabetic pt blood markers
Procedure: Effect of Pulsatile IV Insulin on blood markers
 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: Effect of Pulsatile IV Insulin Delivery on Circulating Risk Markers of Vascular and Metabolic Complications in Pts With Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Florida Atlantic University:

Primary Outcome Measures:
  • Primary: Assessment of effect of Pulsatile Intravenous Insulin therapy on circulating blood markers for diabetic patients. [ Time Frame: Circulating blood markers will be drawn at baseline and every twelve months to monitor and measure results ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: February 2005
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Diabetic patients who meet inclusion criteria will be enrolled to start Pulsatile Intravenous Insulin Therapy on a weekly basis. Baseline testing will be performed and measured against continued testing every twelve months.
 Procedure: Effect of Pulsatile IV insulin on diabetic pt blood markers
Diabetic patients are given pulsatile intravenous insulin on a weekly basis determined by weekly physician order based on pt response and insulin resistance.
Other Name: Humulin, Humulog, Novolog, Epidra
Placebo Comparator: 1
Circulating blood markers will be performed on diabetic control patients at baseline and every twelve months to compare and measure against patients treated with Pulsatile intravenous insulin therapy
 Procedure: Effect of Pulsatile IV Insulin on blood markers
Circulating blood markers are performed at baseline and every twelve months to compare and measure against diabetic patients receiving pulsatile intravenous insulin.
Procedure: Effect of Pulsatile IV insulin on diabetic pt blood markers
Blood markers will be performed on diabetic patients enrolled as control patients at baseline and every twelve months to measure and compare against diabetic patients treated with Pulsatile intravenous insulin therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • We will include up to 500 patients both male and female over the age of 21 diagnosed with type 1 or type 2 diabetes mellitus
  • All patients must have secondary complications caused by the diabetes and not responding to conventional medical management
  • 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

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
  • Positive HIV
  • Inability to perform breathe into machine for respiratory quotients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361907

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
Investigators
Principal Investigator: Betty Tuller, Ph.D Florida Atlantic University
  More Information

Publications:

Responsible Party: Betty Tuller PhD Professor of Complex Systems and Brain Sciences, Florida Atlantic University
ClinicalTrials.gov Identifier: NCT00361907     History of Changes
Other Study ID Numbers: H09-04, MH42900 and MH01386
Study First Received: April 13, 2006
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 Complications
Circulating vascular and inflammatory markers

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013