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

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: NCT00228865
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:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Procedure: Pulsatile IV insulin therapy Procedure: Effects of Pulsatile IV Insulin on Cognitive functions Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Pulsatile IV Insulin on Cognitive Deficits in Diabetic Patients
Study Start Date : June 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: 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

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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

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

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): NCT00228865

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United States, Florida
Florida Atlantic University
Boca Raton, Florida, United States, 33431
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: NCT00228865     History of Changes
Other Study ID Numbers: H09-66-COG
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
Mindstream testing
Wechsler Memory Scale II
Respiratory Quotients
Diabetes Mellitus with cognitive impairment
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