NCT00228878

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus

Timeline
Completed

Started Mar 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.6 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

6.4 years

First QC Date

September 27, 2005

Last Update Submit

August 8, 2016

Conditions

Diabetes Mellitus

Keywords

DiabetesPulsatile intravenous insulinOral carbohydrate loadingRespiratory QuotientsHypoglycemiaDiabetes Mellitus, with complications

Outcome Measures

Primary Outcomes (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.

    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

Study Arms (1)

Effects of Pulsatile IV insulin on QoL

EXPERIMENTAL

Effects of Pulsatile IV insulin on Diabetic Quality of Life

Procedure: Effects of Pulsatile IV insulin on Diabetic Quality of Life

Interventions

Effects of Pulsatile IV insulin on Diabetic Quality of LifePROCEDURE

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.

Also known as: Humulin, Humulog, Novolog
Effects of Pulsatile IV insulin on QoL

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Atlantic University

Boca Raton, Florida, 33487, United States

Location

Related Publications (2)

  • 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

  • Watkins K, Connell CM. Measurement of health-related QOL in diabetes mellitus. Pharmacoeconomics. 2004;22(17):1109-26. doi: 10.2165/00019053-200422170-00002.

    PMID: 15612830BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusHypoglycemiaDiabetes Complications

Interventions

Insulin, Regular, HumanInsulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

InsulinProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-Acting

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

March 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)