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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
| City: |
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Batesville |
| State: |
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Mississippi |
| Zip Code: |
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38606 |
| Conditions: |
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Diabetes Mellitus - Metabolic Integrity |
| Purpose: |
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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.
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| Study Summary: |
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It is known that the glucose metabolic pathway is the primary fuel generator to the brain,
nerve tissue, heart, vascular tissue, eyes, kidneys and the liver. Deficient metabolism
state as seen in the glucose metabolism experienced in many diabetic patients can lead to
complications. 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 20 years that normalization of metabolism in diabetic patients can be
accomplished by mimicking the normal endogenous insulin pattern from the pancreas. Intensive
intravenous insulin bolus has been demonstrated to reverse the metabolic state from primary
fat utilization to carbohydrate utilization through monitoring of the subject's respiratory
quotient.
This study measures whether the reversal of abnormal metabolism in patients with diabetes is
correlated with an improvement in their quality of life and associated complication related
to their diabetes. The respiratory quotient (RQ) is a measurement of CO2 exhaled and O2
inhaled and is proportionate to the fuel sources being used by the body, primarily the liver
over short periods of time. The higher the RQ, the more glucose and less alternative fuel
sources are being utilized. Following the RQ change helps determine the effectiveness of
physiological intravenous bolus insulin administration in increasing anabolic functions in
diabetic individuals. By improving the body's glucose metabolism and thereby causing
beneficial effects of anabolic factors, the possibility of serious complications may be
decreased. In addition, the use of oral carbohydrate at the same time along with the
physiologic intravenous bolus insulin administration stimulates the appropriate gut hormones
which augment this effect, a response which cannot be duplicated with intravenous glucose.
The purpose of our study is to determine whether the physiologic administration of
intravenous bolus insulin along with the augmenting effect of oral carbohydrates will
normalize metabolism in diabetic patients and improve their metabolic integrity and quality
of life indices.
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 20 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 to monitor progress aand outcomes and this is
done before and after each sixty minute intravenous bolus insulin treatment session, during
the 3 successive sessions on a single treatment day. The amount of intravenous insulin and
oral glucose given is determined by monitoring the RQ changes during the previous
session.Intravenous bolus insulin therapy encourages the glucose metabolism in diabetics to
normalize metabolic integrity in multiple organs, especially muscle, retina, liver, kidney
and nerve endings. The process fundamentally requires the administration of high dose
intravenous insulin boluses 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 every thirty minutes or more frequently as medically
necessary to keep glucose levels appropriate and the RQ determines the need to readjust the
infusion protocol in each patient for subsequent intravenous bolus insulin infusion
sessions.Patient is evaluated post session and discharged when stable.
Frequent monitoring of RQ and glucose is necessary as these levels change rapidly, depending
on the fuel being utilized by the body. Intravenous bolus 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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01023165 |
| Primary Contact: |
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Principal Investigator
Michael Cockrell, MD
Global Infusion and Aspiration Systems, LLC
Michael Cockrell, MD
Phone: 662-267-2025
Email: lg@global-infusions.com
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| Backup Contact: |
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Email: lg@globalinfusions.com
Lee Garner, BA
Phone: 662-267-2025
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| Location Contact: |
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Batesville, Mississippi 38606
United States
Lee Garner, BA
Phone: 662-267-2025
Email: lg@global-infusions.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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