Effects of Pulsatile Intravenous Insulin Therapy on Metabolic Integrity in Patients With Diabetes Mellitus

This study has been terminated.
(Administrative)
Sponsor:
Collaborator:
Advanced Diabetes Treatment Centers
Information provided by:
Florida Atlantic University
ClinicalTrials.gov Identifier:
NCT00539409
First received: October 3, 2007
Last updated: August 25, 2009
Last verified: August 2009
  Purpose

The purpose of this study is to determine if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications on the overall quality of life of diabetic patients. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. A diabetic quality of life questionnaire is completed prior to the start of the treatment and quarterly thereafter with detailed analysis performed to measure progress and outcomes


Condition Intervention Phase
Diabetes Mellitus, With Complications
Procedure: Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects on Diabetic Metabolic Integrity With Treatment of Pulsatile Intravenous Insulin Therapy as Evidenced by Monitoring of Diabetic Complications.

Resource links provided by NLM:


Further study details as provided by Florida Atlantic University:

Primary Outcome Measures:
  • Monitor and assess whether Pulsatile Intravenous Insulin Therapy can effect Metabolic Integrity in patients with Diabetes Mellitus. Monitor results of QOL questionnaires, Hgb A1C levels, medications to see if patients complications improve [ Time Frame: Diabetes Quality of Life questionnaires are completed at baseline and every quarter thereafter, Lab values are collected at baseline and every 6 months thereafter, current medications are collected weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: November 2006
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Diabetic patients will complete quality of life questionnaires at baseline and quarterly thereafter to monitor and assess progress with complications resulting from their diabetes. Comparisons will be performed on lab values performed at baseline and every six months and medication information collected at weekly Pulsatile Intravenous Insulin treatment sessions.
Procedure: Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)
Endocrinologist reviews patient activation after treatment each week and adjust the amounts of insulin and carbohydrates to be given in the next session
Other Name: Humulin R, Novolog

  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:

  • The researchers will include up to 750 pts between male and female between -the ages of 21 and 85 diagnosed with diabetes mellitus
  • Self reporting or diagnosed with significant complications resulting from diabetes
  • Taking oral agents and/or insulin for diabetic control
  • Under an Endocrinologist supervision for their diabetes management, Endocrinologist must assess and approve pt for participation in this study
  • Ability to swallow without difficulty
  • Ability to perform Respiratory Quotient requirements by breathing into a mask for 3 minutes at a time

Exclusion Criteria:

  • Lack of Intravenous access
  • Pregnancy
  • Alcohol abuse, drug addiction or the use of illegal drugs
  • Active liver disease
  • Active chemotherapy
  • Positive HIV
  • Inability to breathe into a respiratory quotient machine
  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: NCT00539409

Locations
United States, Florida
Florida Atlantic University
Boca Raton, Florida, United States, 33431
Sponsors and Collaborators
Florida Atlantic University
Advanced Diabetes Treatment Centers
Investigators
Principal Investigator: Betty Tuller, PhD Florida Atlantic University
  More Information

No publications provided

Responsible Party: Betty Tuller PhD Professor of Complex Systems and Brain Sciences, Florida Atlantic University
ClinicalTrials.gov Identifier: NCT00539409     History of Changes
Other Study ID Numbers: H09-66 Main
Study First Received: October 3, 2007
Last Updated: August 25, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Atlantic University:
Diabetes Mellitus
Pulsatile Intravenous Insulin Therapy
Diabetic Quality of Life
Orthostatic Hypotension
Brittle or Labile diabetes

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

ClinicalTrials.gov processed this record on August 28, 2014