Text Size

Effects of Pulsatile Intravenous Insulin Therapy on Cardiac Disease in Patients With Diabetes

This study has been terminated.
(Administrative)
Sponsor:
Collaborator:
Advanced Diabetes Treatment Centers
Information provided by:
Florida Atlantic University
ClinicalTrials.gov Identifier:
NCT00539435
First received: October 3, 2007
Last updated: August 25, 2009
Last verified: August 2009
History of Changes
  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 heart disease in diabetic patients. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. A diabetic cardiac disease quality of life questionnaire is completed prior to the start of the treatment and monthly thereafter with detailed analysis performed to measure progress and outcomes. A carotid ultrasound and echocardiogram are performed at baseline and every six months to monitor progress.


Condition Intervention Phase
Diabetes Mellitus, With Complications
 Procedure: Intravenous Insulin on cardiac disease in diabetic pts
 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 of Pulsatile Intravenous Insulin Therapy on Cardiac Disease in Patients With Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Florida Atlantic University:

Primary Outcome Measures:
  • Monitor and assess whether Pulsatile Intravenous Insulin Therapy can effect progression of cardiac disease in diabetic patients. Monitor results of Cardiac tests,carotid ultrasounds and echocardiograms,cardiac QOL, labs, meds to analyze progress. [ Time Frame: Testing is performed at baseline and every six months thereafter. ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2007
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Diabetic patients will complete cardiac quality of life questionnaires at baseline and monthly thereafter to monitor and assess progress with complications resulting from their heart disease. Comparisons will be performed on carotid ultrasounds,echocardiograms and lab values performed at baseline and every six months and medication information collected at weekly Pulsatile Intravenous Insulin treatment sessions
 Procedure: Intravenous Insulin on cardiac disease in diabetic pts
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 400 pts between male and female between the ages of 21 and 85 diagnosed with diabetes mellitus and cardiac disease
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539435

Locations
United States, Florida
Betty Tuller PhD
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: NCT00539435     History of Changes
Other Study ID Numbers: H09-124
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 Cardiac Quality of Life
Cardiac Disease

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

ClinicalTrials.gov processed this record on May 23, 2013