NCT01029444

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 specifically on the wide swings in blood glucoses with erratic control even under optimal conditions. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. Blood sugar diaries and laboratory tests including quarterly Hemoglobin A1c levels are monitored to measure progress and outcomes.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_3 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, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 10, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

4 years

First QC Date

August 6, 2009

Last Update Submit

February 2, 2016

Conditions

Diabetes Mellitus

Keywords

DiabetesPulsatile intravenous insulinOral carbohydrate loadingRespiratory QuotientsHypoglycemiaHyperglycemiaDiabetes Mellitus, with complications

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effectiveness of Pulsed IV Insulin Therapy on the stabilization of blood glucose levels on patients with brittle or uncontrolled diabetes

    Blood sugar diaries are collected weekly and HA1c labs are collected at baseline and quarterly to assess progress

Study Arms (1)

Insulin

EXPERIMENTAL

Brittle diabetic patients or patients with uncontrolled blood sugars will complete blood sugar diaries weekly and have hemoglobin A1c lab tests performed quarterly to evaluate progress in stabilizing blood sugars.

Procedure: Pulsatile Intravenous Insulin Therapy (Humulin, Humulog, Novolog )

Interventions

Pulsatile Intravenous Insulin Therapy (Humulin, Humulog, Novolog )PROCEDURE

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 RQ levels and their insulin resistance.

Insulin

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The researchers will include up to 300 patients both male and female between the ages of 18 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.
  • 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, 33421, United States

Location

MeSH Terms

Conditions

Diabetes MellitusHypoglycemiaHyperglycemiaDiabetes 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, PhD

    Florida Atlantic University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2009

First Posted

December 10, 2009

Study Start

March 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2012

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

US(1)