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

Sponsors and Collaborators:	Florida Atlantic University 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 (Humulin R, Novolog) on cardiac disease in diabetic pts	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Effects of Pulsatile Intravenous Insulin Therapy on Cardiac Disease in Patients With Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Heart Diseases

Drug Information available for: Insulin Insulin aspart

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. ]

Estimated Enrollment:	400
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2012

Arms	Assigned Interventions
1: Active Comparator 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 (Humulin R, Novolog) 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

Arms

Assigned Interventions

1: Active Comparator

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 (Humulin R, Novolog) 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

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

Contacts

Contact: Paul Mahowald, BA	561-995-7950 ext 107	paul@amtcusa.com
Contact: Dawn Villacci, BA	561-995-7950 ext 104	dvillacci@amtcusa.com

Locations

United States, Florida
Betty Tuller PhD	Recruiting
Boca Raton, Florida, United States, 33431
Contact: Paul Mahowald, BA 561-995-7950 ext 107 paul@amtcusa.com
Principal Investigator: Victor Roberts, MD, FACE

Sponsors and Collaborators

Florida Atlantic University

Advanced Diabetes Treatment Centers

Investigators

Principal Investigator:

Betty Tuller, PhD

Florida Atlantic University

More Information

No publications provided

Study ID Numbers:	H07-142
Study First Received:	October 3, 2007
Last Updated:	October 10, 2007
ClinicalTrials.gov Identifier:	NCT00539435 History of Changes
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

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Heart Diseases
Insulin, Asp(B28)-
Diabetes Mellitus
Quality of Life

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Heart Diseases
Physiological Effects of Drugs
Insulin, Asp(B28)-
Diabetes Mellitus

Endocrine System Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on July 02, 2009