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

NCT01023165 | Unknown Phase 3 DMC

• 1 other identifier: GI-001
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Metabolic Integrity

Keywords

Diabetes Mellitus; Metabolic Integrity; Intravenous Bolus Insulin

Outcome Measures

Primary Outcomes (1)

• Researchers will assess whether restoring metabolic integrity to diabetic patients improves quality of life and complications associated with diabetes

  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.

Study Arms (1)

IV bolus insulin, metabolic integrity

EXPERIMENTAL

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

Interventions

Humulin, Humalog, Novolog PROCEDURE

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.

IV bolus insulin, metabolic integrity

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Global Infusion and Aspiration Systems, LLC: lead

Study Sites (1)

Global Infusion and Aspiration Systems, LLC

Batesville, Mississippi, 38606, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin, Regular, Human; Insulin Lispro; Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Michael Cockrell, MD

  Global Infusion and Aspiration Systems, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Cockrell, MD

CONTACT

662-267-2025; lg@global-infusions.com

Lee Garner, BA

CONTACT

662-267-2025; lg@globalinfusions.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2015
• Last Updated: June 22, 2011

Record last verified: 2011-06

Locations

US (1)