NCT00228865

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_2 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

6.2 years

First QC Date

September 27, 2005

Last Update Submit

August 8, 2016

Conditions

Diabetes Mellitus

Keywords

Pulsatile intravenous insulinOral carbohydrate loadingMindstream testingWechsler Memory Scale IIRespiratory QuotientsHypoglycemiaDiabetes Mellitus with cognitive impairmentDiabetes Mellitus with complications

Outcome Measures

Primary Outcomes (3)

  • 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

    Testing performed at baseline and quarterly to compare and analyze patient's results after receiving pulsatile intravenous insulin therapy

  • Utilizing the Wechsler Memory Scale II, Type II diabetic patients are tested on recall on a quarterly basis to track improvement in cognitive function.

    Testing performed at baseline and quarterly to evaluate progress in cognitive functions

  • 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.

    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

Study Arms (1)

1

EXPERIMENTAL

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 therapyProcedure: Effects of Pulsatile IV Insulin on Cognitive functions

Interventions

Pulsatile IV insulin therapyPROCEDURE

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

Also known as: Insulin includes Humulin, Humulog, Novolog and Epidra
1
Effects of Pulsatile IV Insulin on Cognitive functionsPROCEDURE

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.

Also known as: Humulin, Humulog
1

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Atlantic University

Boca Raton, Florida, 33431, United States

Location

Related Publications (5)

  • Hammond GS, Aoki TT. Measurement of health status in diabetic patients. Diabetes impact measurement scales. Diabetes Care. 1992 Apr;15(4):469-77. doi: 10.2337/diacare.15.4.469.

    PMID: 1499460BACKGROUND

  • Stewart R, Liolitsa D. Type 2 diabetes mellitus, cognitive impairment and dementia. Diabet Med. 1999 Feb;16(2):93-112. doi: 10.1046/j.1464-5491.1999.00027.x.

    PMID: 10229302BACKGROUND

  • Gregg EW, Yaffe K, Cauley JA, Rolka DB, Blackwell TL, Narayan KM, Cummings SR. Is diabetes associated with cognitive impairment and cognitive decline among older women? Study of Osteoporotic Fractures Research Group. Arch Intern Med. 2000 Jan 24;160(2):174-80. doi: 10.1001/archinte.160.2.174.

    PMID: 10647755BACKGROUND

  • Steen E, Terry BM, Rivera EJ, Cannon JL, Neely TR, Tavares R, Xu XJ, Wands JR, de la Monte SM. Impaired insulin and insulin-like growth factor expression and signaling mechanisms in Alzheimer's disease--is this type 3 diabetes? J Alzheimers Dis. 2005 Feb;7(1):63-80. doi: 10.3233/jad-2005-7107.

    PMID: 15750215BACKGROUND

  • Watson GS, Craft S. Modulation of memory by insulin and glucose: neuropsychological observations in Alzheimer's disease. Eur J Pharmacol. 2004 Apr 19;490(1-3):97-113. doi: 10.1016/j.ejphar.2004.02.048.

    PMID: 15094077BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusHypoglycemiaDiabetes Complications

Interventions

Insulin AspartInsulin, Regular, Human

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulinProinsulin

Study Officials

  • Betty Tuller, Ph.D.

    Florida Atlantic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

June 1, 2003

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations

US(1)