Working… Menu

Effects of Pulsatile Intravenous Insulin Therapy on Metabolic Integrity in Patients With Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00539409
Recruitment Status : Terminated (Administrative)
First Posted : October 4, 2007
Last Update Posted : August 10, 2016
Advanced Diabetes Treatment Centers
Information provided by (Responsible Party):
Florida Atlantic University

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 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 quarterly thereafter with detailed analysis performed to measure progress and outcomes

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, With Complications Procedure: Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog) Phase 2 Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects on Diabetic Metabolic Integrity With Treatment of Pulsatile Intravenous Insulin Therapy as Evidenced by Monitoring of Diabetic Complications.
Study Start Date : November 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: 1
Diabetic patients will complete quality of life questionnaires at baseline and quarterly 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.
Active Comparator: Pulsatile Intravenous Insulin Therapy Procedure: Pulsatile Intravenous Insulin Therapy (Humulin R, Novolog)
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

Primary Outcome Measures :
  1. 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 quarter thereafter, Lab values are collected at baseline and every 6 months thereafter, current medications are collected weekly ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00539409

Layout table for location information
United States, Florida
Florida Atlantic University
Boca Raton, Florida, United States, 33431
Sponsors and Collaborators
Florida Atlantic University
Advanced Diabetes Treatment Centers
Layout table for investigator information
Principal Investigator: Betty Tuller, PhD Florida Atlantic University

Layout table for additonal information
Responsible Party: Florida Atlantic University Identifier: NCT00539409     History of Changes
Other Study ID Numbers: H09-66 Main
First Posted: October 4, 2007    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Keywords provided by Florida Atlantic University:
Diabetes Mellitus
Pulsatile Intravenous Insulin Therapy
Diabetic Quality of Life
Orthostatic Hypotension
Brittle or Labile diabetes
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs