Effects of Pulsatile Intravenous Insulin Therapy on Cardiac Disease in Patients With Diabetes - Full Text View

Sponsor:	Florida Atlantic University
Collaborator:	Advanced Diabetes Treatment Centers
Information provided by:	Florida Atlantic University
ClinicalTrials.gov Identifier:	NCT00539435

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 III

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Heart Diseases Ultrasound

Drug Information available for: Insulin Insulin beef

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

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 February 12, 2012