AzTrials
AzTrials

Diabetes MellitusPhase 3NCT01029444

Effects of Pulsed Intravenous (IV) Insulin on Brittle and Uncontrolled Diabetes

A Phase 3 study testing Pulsatile Intravenous Insulin Therapy (Humulin, Humulog, Novolog ) in people with Diabetes Mellitus, run by Florida Atlantic University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Pulsatile Intravenous Insulin Therapy (Humulin, Humulog, Novolog )
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
Mar 2007to Mar 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Florida Atlantic University

    Boca Raton, Florida, 33421

Other trials in United States

About this study

Official title: Effects of Pulsatile Intravenous Insulin on Brittle Diabetes and Glucose Control

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.

Read the detailed description

It is known that the glucose metabolic pathway (glycolysis) is the primary fuel generator in the brain and nerve tissue, the heart and vascular tissue, the eye, the kidney and the liver Deficient metabolic states such as seen in the glucose metabolism of diabetics can lead to sequelae. These damaging effects are exacerbated by altered cellular metabolites, specifically the increase in catabolic and decrease in anabolic factors. It has been shown over the past twenty years that normalization of metabolism in diabetic patients can be accomplished by mimicking the normal endogenous insulin pattern (i.e., in pulses). Pulsatile intravenous insulin infusion has been demonstrated to stabilize the erratic wide swings in blood glucose levels and the overall stabilization of hyperglycemic and hypoglycemic events in Type 1 diabetic patients. This study was established to evaluate the effect of providing pulsatile intravenous insulin therapy on both type 1 and type 2 diabetes to determine the effect on improving diabetic control on patients with high blood glucose levels in spite of multiple insulin injections and wide swings in blood sugar despite good control.

The RQ is determined by the use of a metabolic cart. Individuals breathe into a mask for 3-5 minutes after a rest period of 30 or more minutes. The ratio of exhaled volume of CO2 to the inhaled volume of O2 is determined as the RQ. The physiologic range is 0.7 to1.3. Individuals using fat as a primary fuel have a ratio of 0.7, protein or mixed fuels is 0.8-0.9 and carbohydrate is 0.9-1.0. Those taking excessive calories will have RQ's higher than 1.05. The RQ can be followed serially and this is done before and after each pulsatile IV insulin treatment, during the 3 successive sessions on a single treatment day. The amount of intravenous insulin and oral glucose given is determined by the RQ changes during the previous session.pulsatile IV insulin therapy encourages the glucose metabolism in diabetics to normalize in multiple organs, especially muscle, retina, liver, kidney and nerve endings. The process fundamentally requires the administration of high dose insulin pulses similar to those found in non diabetic humans by their pancreas into the surrounding portal circulation. Oral carbohydrates are given simultaneously to augment the process and prevent hypoglycemia. The process is monitored by frequent glucose levels and respiratory quotients (RQ). RQ is measured by a metabolic cart which determines the ratio VCO2/ VO2. This ratio is specific for the fuel used at any one time by the body. The glucose levels are monitored to keep glucose levels appropriate and the RQ determines the need to readjust the infusion protocol in each patient for subsequent insulin infusion sessions.Patient is evaluated post session and discharged when stable.

Frequent monitoring of RQ is necessary as these levels change rapidly, depending on the fuel being utilized by the body. Pulsatile IV insulin therapy shifts metabolism from primarily fatty acid metabolism to primarily glucose metabolism. This shift is reflected by the increase in respiratory quotient. However during rest periods the RQ may fall back to lower levels. Therefore RQ's are done at the beginning and at the end of each insulin infusion session of 1 hour in order to appropriately monitor and adjust insulin and carbohydrate loads to reach optimal activation in each session

Being tested
Pulsatile Intravenous Insulin Therapy (Humulin, Humulog, Novolog )
Keywords
Diabetes, Pulsatile intravenous insulin, Oral carbohydrate loading, Respiratory Quotients, Hypoglycemia, Hyperglycemia, Diabetes Mellitus, with complications
Medical subject headings
Diabetes Mellitus, Hypoglycemia, Hyperglycemia, Diabetes Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulsatile Intravenous Insulin Therapy (Humulin, Humulog, Novolog )Procedure or surgery

    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.

Study groups in NCT01029444
Study groupRoleWhat they receive
InsulinExperimentalBrittle 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.
Receives: Procedure: Pulsatile Intravenous Insulin Therapy (Humulin, Humulog, Novolog )

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2009 (estimated)
  2. Study startMar 2007
  3. Primary completionMar 2011
  4. Study completionMar 2012

Why it stopped: Administrative

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01029444
Sponsor's protocol ID
H09-66 BUD
Status last verified
Feb 2016
First submitted
6 Aug 2009
Last updated
3 Feb 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pulsatile Intravenous Insulin Therapy (Humulin, Humulog, Novolog ) in people with Diabetes Mellitus, run by Florida Atlantic University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Administrative). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the effectiveness of Pulsed IV Insulin Therapy on the stabilization of blood glucose levels on patients with brittle or uncontrolled diabetes (time frame: Blood sugar diaries are collected weekly and HA1c labs are collected at baseline and quarterly to assess progress). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in