Effects of Pulsatile Intravenous Insulin Therapy on Metabolic Integrity in Patients With Diabetes Mellitus - Full Text View

Sponsors and Collaborators:	Florida Atlantic University Advanced Diabetes Treatment Centers
Information provided by:	Florida Atlantic University
ClinicalTrials.gov Identifier:	NCT00539409

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 monthly 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 II Phase III

MedlinePlus related topics: Diabetes Diabetes Complications

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Effects on Diabetic Metabolic Integrity With Treatment of Pulsatile Intravenous Insulin Therapy as Evidenced by Monitoring of Diabetic Complications.

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 month thereafter, Lab values are collected at baseline and every 6 months thereafter, current medications are collected weekly ]

Estimated Enrollment:	750
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2011

Arms	Assigned Interventions
1: Active Comparator Diabetic patients will complete quality of life questionnaires at baseline and monthly 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 treatmetn each week and adjust the amounts of insulin and carbohydrates to be given in the next session

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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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539409

Contacts

Contact: Paul Mahowald, BA	561-314-2540	paul@amtcusa.com
Contact: Dawn Villacci, BA	561-314-2544	dvillacci@amtcusa.com

Locations

United States, Florida
Florida Atlantic University	Recruiting
Boca Raton, Florida, United States, 33431
Contact: Paul Mahowald, BA 561-314-2540 paul@amtcusa.com
Principal Investigator: Betty Tuller, PhD

Sponsors and Collaborators

Florida Atlantic University

Advanced Diabetes Treatment Centers

Investigators

Principal Investigator:

Betty Tuller, PhD

Florida Atlantic University

More Information

Study ID Numbers:	H07-49
Study First Received:	October 3, 2007
Last Updated:	October 10, 2007
ClinicalTrials.gov Identifier:	NCT00539409
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

Study placed in the following topic categories:

Hypotension
Hypotension, Orthostatic
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Quality of Life
Insulin

Postural hypotension
Insulin, Asp(B28)-
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Diabetes Complications

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009