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Combinations of chromium or vanadium with antidiabetics for glucose metabolism disorders

a technology of chromium vanadium and antidiabetic, which is applied in the direction of metabolism disorder, extracellular fluid disorder, peptide/protein ingredient, etc., can solve the problems of increasing the number of insulin deficiencies, reducing the effect of chromium vanadium, and affecting the way the body uses sugar, so as to prevent or delay the on-set of diabetes or diabetic symptoms, and preserving health

Inactive Publication Date: 2005-10-20
FINE STUART A +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention provides new treatments for diabetes and related metabolic disorders. The invention includes compositions and methods for regulating glucose metabolism and lipid metabolism in a way that benefits the patient. The invention can be applied to prevent, treat, or reduce the severity of diabetes and its related conditions, including hyperglycemia, hyperinsulinemia, hypertriglyceridemia, and elevated blood pressure. The invention also includes supplements or compositions containing anti-diabetic agents and other components to help manage these conditions. The invention can be used as a therapeutic regimen or in the manufacture of a medicament for the treatment of diabetes and related metabolic disorders. The invention is designed to provide a therapeutic effect without elevating certain parameters, such as blood glucose levels, and can be used in preventive care regimes. The invention is also directed to a dietary supplement that can be formulated for individuals with increased risk of diabetes."

Problems solved by technology

Diabetes adversely affects the way the body uses sugars and starches which, during digestion, are converted into glucose.
In Type 2 diabetes, the pancreas retains the ability to produce insulin and in fact may produce higher than normal amounts of insulin, but the amount of insulin is relatively insufficient, or less than fully effective, because of cellular resistance to insulin.
Uncontrolled hyperglycemia may transiently adversely affect the insulin-producing cells of the pancreas (the beta-islet cells), which may eventually result in greater insulin deficiencies.
The cumulative effect of these diabetes-associated abnormalities may be severe blood vessel and nerve damage.
Although progress has been made in reducing the short term complications of diabetes, e.g. ketoacidosis, dehydration, and non-ketotic hyperosmolar coma, less progress has been made in preventing or minimizing the chronic complications of the disease, e.g. premature atherosclerosis, retinopathy, nephropathy, and neuropathy.
It is estimated that a diabetic patient's life is shortened by 10 to 15 years, and those years of life are distinguished by significantly increased medical care costs as compared to a non-diabetic patient.
Another complication of diabetes is increased cardiovascular risk factor, especially among women.
For example, populations studies have shown that an elevated concentration of total cholesterol or LDL-cholesterol in plasma constitutes a major risk factor for the occurrence of atherosclerotic events.
Furthermore, there may be an excessive risk of cardiac mortality in diabetic patients even after adjusting for the co-existence of other cardiovascular risk factors such as hypertension, dyslipidemia, and cigarette smoking.
This increase risk of cardiac mortality is secondary to both the atherogenicity of insulin resistance, which may precede the onset of diabetes by at least 8 years, and the atherogenicity of undiagnosed and uncontrolled hyperglycemia, which may be present for 9-12 years before diabetes is first diagnosed.
In addition, there are a number of proposed therapies for treatment of diabetes that have not yet been approved for human use.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example one

[0231] A supplement (detailed below) was administered daily to a female with Type 2 diabetes who was experiencing poor blood sugar control while taking metformin 500 mg b.i.d. In conjunction with continued metformin administration, the patient was given an oral daily nutritional supplement comprising the following ingredients: chromium 333 mcg (in the form of chromium picolinate / polynicotinate); magnesium 46 mg (in the form of 384 mg magnesium chloride); vanadyl-sulfate hydrate 100 mg; vitamin E 400 I.U, and folate 400 mcg.

[0232] The results are summarized below in Table 1

TABLE 1HbA1cEstimated BloodFasting BloodTherapeutic RegimenLevelSugar (mg / dL)Sugar (mg / dL)Metformin alone9.7200185Metformin &7.9141153composition(after 2 months)

[0233] The above results indicate the degree to which a composition consisting of components and an anti-diabetic agent according to the present invention, administered in accordance with invention methods, may dramatically improve blood sugar control an...

example two

[0236] To further test the efficacy of inventive compositions, a certain embodiment of the present invention, the supplement detailed below, was administered daily to a 27 year old female with Type 2 diabetes who was experiencing poor blood sugar control while taking metformin 1000 mg b.i.d.

[0237] After 3 months of augmenting the daily regimen of 2000 mg metformin with the above oral nutritional supplement, the patient's HbA1c level dropped from 8.3 to 6.1. These results again serve to demonstrate the degree to which invention compositions, administered in accordance with invention methods, serves to beneficially lower a diabetic patient's HbA1c levels, even though the patient had experienced poor blood glucose control on high doses of metformin alone.

example three

[0238] In another example, a group of Type 2 diabetic individuals presenting with elevated HbA1c levels were placed on a program using a variety of embodiments of the present invention. The study was conducted as an open-label study at five different medical centers in the United States. The patients were on the program for three months, and were directed not to change their dietary habits or lifestyle, including exercise patterns.

[0239] For this Example Three, one daily dose of every embodiment contained, in addition to any of the anti-diabetic agents set forth in the accompanying tables, the following (component and amount):

[0240] Vitamin A, 5000 IU; Vitamin C (Ascorbic Acid), 60 mg; Vitamin D-3, 400 IU; Vitamin E (free 2R, 4′R, 8′R-alpha-tocopherol), 400 IU; Thiamine (as Thiamine Mononitrate), 3 mg; Riboflavin, 3.6 mg; Niacinamide, 20.1 mg; Vitamin B-6 (as Pyridoxine HCl), 23.1 mg; Folic Acid, 400 mcg; Vitamin B-12, 48 mcg; Biotin, 300 mcg; Pantothenic Acid (as Calcium Pantothe...

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Abstract

Compositions and methods of using the same for the treatment of diabetes and other disorders of glucose metabolism are provided. Compositions may include an anti-diabetic agent and one or more of a bioavailable source of chromium and vanadium.

Description

RELATED APPLICATION INFORMATION [0001] This application is a Continuation-in-Part of application Ser. No. 09 / 156,102, filed Sep. 17, 1998, and this application claims the benefit of priority under 35 U.S.C. section 119(e) to Provisional Application 60 / 126,489, filed Mar. 26, 1999, both of which Applications are hereby incorporated by reference in their entirety.BACKGROUND OF THE INVENTION [0002] Diabetes adversely affects the way the body uses sugars and starches which, during digestion, are converted into glucose. Diabetes mellitus is generally caused in almost all instances by diminished rates of insulin secretion (absolute or relative) by the beta cells of the islets of Langerhans in the pancreas or by reduced insulin sensitivity. Insulin, a hormone produced by the pancreas, makes the glucose available to the body's cells for energy. In muscle, adipose (fat), and connective tissues, insulin facilitates the entry of glucose into the cells by an action on the cell membranes. The in...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K33/24A61K31/155A61K31/175A61K31/426A61K31/555A61K38/28A61K45/06
CPCA61K31/155A61K31/175A61K31/426A61K31/555A61K33/24A61K45/06A61K2300/00A61P3/08A61P3/10
Inventor FINE, STUART A.KINSELLA, KEVIN J.
Owner FINE STUART A
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