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

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ClinicalTrials.gov Identifier: NCT00228878
Recruitment Status : Terminated (Administrative)
First Posted : September 29, 2005
Last Update Posted : August 10, 2016
Sponsor:
Collaborator:
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

  Show Detailed Description

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

U.S. FDA Resources

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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00228878


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

Publications:
Responsible Party: Florida Atlantic University
ClinicalTrials.gov Identifier: NCT00228878     History of Changes
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:
Diabetes
Pulsatile intravenous insulin
Oral carbohydrate loading
Respiratory Quotients
Hypoglycemia
Diabetes Mellitus, with complications

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs