Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Intensive Bolus Intravenous Insulin Delivery on Metabolic Integrity in Type 1 and Type 2 Diabetes

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.
 
ClinicalTrials.gov Identifier: NCT01023165
Recruitment Status : Unknown
Verified June 2011 by Global Infusion and Aspiration Systems, LLC.
Recruitment status was:  Recruiting
First Posted : December 2, 2009
Last Update Posted : June 22, 2011
Sponsor:
Information provided by:
Global Infusion and Aspiration Systems, LLC

Brief Summary:
The purpose of this study is to determine if restoring normal metabolic function in patients with type 1 or type 2 diabetes can improve the impact of the consequences of diabetic complications on the overall health and quality of life for diabetic patients.Patients are treated once per week with intensive bolus intravenous insulin delivery mimicking normal insulin secretions in a non diabetic individual. Baseline and periodic diagnostic tests are performed and questionnaires completed to evaluate and monitor progress and outcomes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Metabolic Integrity Procedure: Humulin, Humalog, Novolog Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Trial to Evaluate the Effects of Intensive Bolus Intravenous Insulin Delivery on Metabolic Integrity in Type 1 and Type 2 Diabetics Who Despite Tight Control and Proper Diet Still Suffer From Metabolic Problems
Study Start Date : November 2009
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IV bolus insulin, metabolic integrity
Diabetic patients will complete diagnostic testing and complete quality of life questionnaires at baseline and every six months thereafter while enrolled in the study to monitor and assess progress with metabolic integrity and complications resulting from their diabetes. Comparisons will be performed on lab values performed at baseline and every six months thereafter. Supervising physician may request testing be performed more frequently as deemed medically necessary, testing may include retinal photography, nerve conduction and labs. Meds and medical intervention information is collected weekly at the Intravenous Bolus Insulin treatment sessions. An annual evaluation is performed to review clinical data collected and evaluate progress for analysis and comparison.
Procedure: Humulin, Humalog, Novolog
Supervising Physician reviews patient activation after intravenous bolus insulin treatment each week and adjusts the amounts of insulin and carbohydrates to be given in the next treatment session based on patient treatment outcomes.




Primary Outcome Measures :
  1. Researchers will assess whether restoring metabolic integrity to diabetic patients improves quality of life and complications associated with diabetes [ Time Frame: Patients will have diagnostic testing and complete questionnaires at baseline and every six months thereafter or more frequently if the supervising physician deems medically appropriate throughout the study to monitor and evaluate progress. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with significant complications resulting from diabetes
  • Ability to swallow without difficulty
  • Ability to perform Respiratory Quotient requirements by breathing into a mask for 3 minutes at a time Supervising physician must evaluate and diagnose one of the following medical conditions to be eligible to participate in study
  • Hypoglycemia unawareness
  • Significant proteinuria (>300 mg/24 hrs) in spite of ACE inhibitors and/or ARB's.
  • Diabetic nephropathy
  • Progressive, significant diabetic peripheral neuropathy.
  • Orthostatic hypotension due to autonomic neuropathy of advanced diabetes.
  • Advanced gut neuropathy with gastroparesis or diabetic diarrhea.
  • Non-healing diabetic wounds
  • Diabetic retinopathy

Exclusion Criteria:

  • Lack of intravenous access
  • Inability to breathe into a respiratory quotient machine
  • Subjects on dialysis
  • Presence of severe underlying chronic disease (e.g. coronary artery disease, hepatic disease) which in the opinion of the investigator is likely to preclude the subject from completing the full term of the study
  • Inability to stabilize blood pressure at 140/90 or below using ACE inhibitors, Ca channel blockers, Alpha 1 blockers, central Alpha2 agonists or diuretics
  • Pregnancy or contemplated pregnancy
  • Alcohol abuse, drug addiction or the use of illegal drugs
  • Active liver disease
  • Active chemotherapy
  • Positive HIV
  • Subjects with a history of poor compliance to drug or diet or placebo therapy or keeping appointments

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 ClinicalTrials.gov identifier (NCT number): NCT01023165


Contacts
Layout table for location contacts
Contact: Michael Cockrell, MD 662-267-2025 lg@global-infusions.com
Contact: Lee Garner, BA 662-267-2025 lg@globalinfusions.com

Locations
Layout table for location information
United States, Mississippi
Global Infusion and Aspiration Systems, LLC Recruiting
Batesville, Mississippi, United States, 38606
Contact: Lee Garner, BA    662-267-2025    lg@global-infusions.com   
Principal Investigator: Michael Cockrell, MD         
Sponsors and Collaborators
Global Infusion and Aspiration Systems, LLC
Investigators
Layout table for investigator information
Principal Investigator: Michael Cockrell, MD Global Infusion and Aspiration Systems, LLC

Layout table for additonal information
Responsible Party: Michael Cockrell MD, Global Infusion and Aspiration Systems, LLC
ClinicalTrials.gov Identifier: NCT01023165     History of Changes
Other Study ID Numbers: GI-001
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011
Keywords provided by Global Infusion and Aspiration Systems, LLC:
Diabetes Mellitus
Metabolic Integrity
Intravenous Bolus Insulin
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs