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Effect Pulsatile IV Insulin Therapy on the Quality of Life in Patients With Types 1 and 2 Diabetes

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: NCT00228878
Recruitment Status : Terminated (Administrative)
First Posted : September 29, 2005
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 44 item 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 Procedure: Effects of Pulsatile IV insulin on Diabetic Quality of Life Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quality of Life With and Without Pulsatile IV Insulin Therapy in Diabetes.
Study Start Date : March 2003
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Effects of Pulsatile IV insulin on QoL
Effects of Pulsatile IV insulin on Diabetic Quality of Life
Procedure: Effects of Pulsatile IV insulin on Diabetic Quality of Life
Patients receive weekly treatments of Pulsatile Intravenous insulin therapy. The patient's Endocrinologist determines the insulin dosage each week based upon the patient's response to treatment and their insulin resistance.
Other Name: Humulin, Humulog, Novolog

Primary Outcome Measures :
  1. Researchers will assess whether pulsatile IV insulin therapy can successfully reverse the abnormal underlying metabolism in diabetic patients to the point of improving their quality of life. [ Time Frame: Patients will complete a quality of life questionnaire prior to the start of treatment and quarterly thereafter to objectively determine if the patients identify quality of life improvement ]

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.

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The researchers will include up to 200 patients both male and female between the ages of 21 and 85 diagnosed with type 1 or type 2 diabetes mellitus.
  • Self reporting or diagnosed with significant complications resulting from diabetes
  • Taking oral agents and/or insulin for diabetic control
  • Under an Endocrinologists supervision for their diabetes management. Endocrinologist must assess and approve patient for participation in this study
  • Ability to swallow without difficulty
  • Ability to commit to the weekly time requirements associated with the study

Exclusion Criteria:

  • Other causes of complications not related to diabetes
  • Inability to respond to 44 item questionnaire
  • Lack of intravenous access
  • Pregnancy
  • Alcohol abuse, drug addiction or the use of illegal drugs
  • Positive HIV
  • Inability to breathe into machine for respiratory quotients

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): NCT00228878

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United States, Florida
Florida Atlantic University
Boca Raton, Florida, United States, 33487
Sponsors and Collaborators
Florida Atlantic University
Advanced Diabetes Treatment Centers
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Principal Investigator: Betty Tuller, Ph.D Florida Atlantic University

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Responsible Party: Florida Atlantic University Identifier: NCT00228878    
Other Study ID Numbers: H09-66-QOL
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Keywords provided by Florida Atlantic University:
Pulsatile intravenous insulin
Oral carbohydrate loading
Respiratory Quotients
Diabetes Mellitus, with complications
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs