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

This study has been terminated.
(Administrative)
Sponsor:
Collaborator:
Advanced Diabetes Treatment Centers
Information provided by:
Florida Atlantic University
ClinicalTrials.gov Identifier:
NCT00228878
First received: September 27, 2005
Last updated: August 25, 2009
Last verified: August 2009
  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 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 Intervention Phase
Diabetes Mellitus
Procedure: Effects of Pulsatile IV insulin on Diabetic Quality of Life
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Quality of Life With and Without Pulsatile IV Insulin Therapy in Diabetes.

Resource links provided by NLM:


Further study details as provided by Florida Atlantic University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: March 2003
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Diabetic patients will complete diabetic impact measurement scale questionnaires at baseline and quarterly thereafter in order to determine and track outcomes after the start of pulsatile intravenous insulin therapy.
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Betty Tuller PhD Professor of Complex Systems and Brain Sciences, Florida Atlantic University
ClinicalTrials.gov Identifier: NCT00228878     History of Changes
Other Study ID Numbers: H09-66-QOL
Study First Received: September 27, 2005
Last Updated: August 25, 2009
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014