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Clinical Effects of Pulsatile Insulin Delivery on Cognitive Function- Phase 1

This study has been terminated.
(Administrative)
Sponsor:
Collaborator:
Advanced Diabetes Treatment Centers
Information provided by:
Florida Atlantic University
ClinicalTrials.gov Identifier:
NCT00228865
First received: September 27, 2005
Last updated: August 25, 2009
Last verified: August 2009
History of Changes
  Purpose

To determine if restoring normal metabolic function in patients with either Type I or Type II Diabetes can improve overall cognitive function. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion and high amounts of oral glucose consumption.


Condition Intervention Phase
Diabetes Mellitus
 Procedure: Pulsatile IV insulin therapy
Procedure: Effects of Pulsatile IV Insulin on Cognitive functions
 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: Effects of Pulsatile IV Insulin on Cognitive Deficits in Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Florida Atlantic University:

Primary Outcome Measures:
  • By utilizing Mindstream testing and/or Wechsler Memory Scale II on a quarterly basis to track the patients' progress, we will evaluate and document the outcomes of providing Metabolic Activation Therapy over a twelve month period. Documentation will inc [ Time Frame: Testing performed at baseline and quarterly to compare and analyze patient's results after receiving pulsatile intravenous insulin therapy ] [ Designated as safety issue: No ]
  • Utilizing the Wechsler Memory Scale II, Type II diabetic patients are tested on recall on a quarterly basis to track improvement in cognitive function. [ Time Frame: Testing performed at baseline and quarterly to evaluate progress in cognitive functions ] [ Designated as safety issue: No ]
  • Using repetitive respiratory quotients, we will assess the success of the reversal of the abnormal underlying metabolism in diabetic patients from primarily fat metabolism to carbohydrate metabolism. [ Time Frame: Testing performed at the beginning and end of each pulsatile intravenous insulin therapy session to determine the need to modify the amount of insulin given to the patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: June 2003
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Testing performed on diabetic patients with decline in cognitive function at baseline and quarterly after the start of receiving pulsatile intravenous insulin therapy to assess continuing cognitive function ability.
 Procedure: Pulsatile IV insulin therapy
Diabetic pts are given pulsatile iv insulin on a weekly basis determined by weekly phys orders based on pt response and insulin resistance. Cognitive testing is performed quarterly to track progress
Other Name: Insulin includes Humulin, Humulog, Novolog and Epidra
Procedure: Effects of Pulsatile IV Insulin on Cognitive functions
Diabetic patients receive weekly treatment of Pulsatile Intravenous Insulin therapy. Dosage is determined each week by the patient's Endocrinologist based upon the patient's response and insulin resistance.
Other Name: Humulin, Humulog

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion Criteria:
  • diagnosed with type 1 or type 2 diabetes mellitus.
  • Self reporting or diagnosed with memory changes
  • Taking oral agents and/or insulin for diabetic control
  • Under Endocrinologist's supervision for 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 cognitive impairment not related to diabetes
  • Inability to take cognitive testing
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00228865

Locations
United States, Florida
Florida Atlantic University
Boca Raton, Florida, United States, 33431
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: NCT00228865     History of Changes
Other Study ID Numbers: H09-66-COG
Study First Received: September 27, 2005
Last Updated: August 25, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Atlantic University:
Pulsatile intravenous insulin
Oral carbohydrate loading
Mindstream testing
Wechsler Memory Scale II
 Respiratory Quotients
Hypoglycemia
Diabetes Mellitus with cognitive impairment
Diabetes Mellitus with complications

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

ClinicalTrials.gov processed this record on May 22, 2013