Combinations of chromium or vanadium with antidiabetics for glucose metabolism disorders

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...

AI Technical Summary

Benefits of technology

[0020] In certain embodiments, the present invention provides compositions, and methods of using the same, for regulating, modulating or altering glucose metabolism in a manner beneficial to the patient. Generally, various embodiments of the invention may be applied or tailored to specifically treat or address each condition described herein and others like them, including any condition or disorder related to glucose metabolism disorders. In certain embodiments, compositions of the present invention, and methods of using the same, are provided for preventing, reducing or treating in animal subjects (including humans and other mammals) one or more of the following physiological conditions: insulin resistance (the sensitivity of the cellular response to insulin), beta cell attrition, hyperinsulinemia, hyperglycemia, hepatic gluconeogenesis, onset of diabetes or diabetic symptoms, elevated HbA1c levels, and elevated or inappropriately controlled blood glucose levels. In certain embodiments, the present invention abates, or otherwise reduces the severity of, diabetes and other glucose metabolism disorders, including Type 1, Type 2, MODY, and IGT, and any related sequelae, including, for example, obesity, obesity-related hypertension, retinopathy, nephropathy, neuropathy, cataracts, coronary artery disease and arteriosclerosis. In certain embodiments, subject compositions contain one or more anti-diabetic agents and one or more other components. Such anti-diabetic agents and other such components may or may not be administered together or by the same means.

[0021] In other embodiments, the present invention provides supplements or compositions, and methods of using the same, for regulating, modulating or altering lipid metabolism in a manner beneficial to the patient. For example, the subject compositions, and methods of using the same, can be used to modulate at least one of body fat stores, blood pressure, hyperlipoproteinemia, hypertriglyceridemia, serum cholesterol level, HDL level and LDL level. In certain embodiments, the present invention abates or otherwise reduces the severity of dyslipidemia, atherosclerosis and CHD. In still other embodiments, the present invention provides compositions and supplements, and methods for using the same, to reduce appetite for cosmetic purposes or treatment of illness, dysfunction or obesity.

[0024] In some instances, the present invention is designed to regulate any of the physiological processes described herein so as to achieve a desired level of a physiological parameter (e.g., a HbA1c level of about 5). In certain embodiments, such a result is achieved without subjecting a patient to elevated levels of such a parameter. Such embodiments of the invention may prove useful in preserving health or reducing, preventing or delaying the on set of diabetes or diabetic symptoms without the patient experiencing the full thrust of such medical conditions. These aspects of the invention are particularly helpful in preventive care regimes.

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.