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

NCT00539435 | Withdrawn Phase 3 DMC

• 1 other identifier: H09-124
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, With Complications

Keywords

Diabetes Mellitus; Pulsatile Intravenous Insulin Therapy; Diabetic Cardiac Quality of Life; Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Testing is performed at baseline and every six months thereafter.

Study Arms (1)

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 on cardiac disease in diabetic pts

Interventions

Intravenous Insulin on cardiac disease in diabetic pts PROCEDURE

Endocrinologist reviews patient activation after treatment each week and adjust the amounts of insulin and carbohydrates to be given in the next session

Also known as: Humulin R, Novolog

1

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida Atlantic University: lead
• Advanced Diabetes Treatment Centers: collaborator

Study Sites (1)

Betty Tuller PhD

Boca Raton, Florida, 33431, United States

Location

MeSH Terms

Conditions

Diabetes Complications; Diabetes Mellitus; Heart Diseases

Interventions

Insulin; Insulin Aspart

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Betty Tuller, PhD

  Florida Atlantic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2007
• First Posted: October 4, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

US (1)