Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Heavy metal or compound thereof
Reexamination Certificate
1999-03-19
2001-03-20
Jarvis, William R. A. (Department: 1614)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Heavy metal or compound thereof
C424S655000, C424S681000, C424S682000, C514S165000, C514S458000
Reexamination Certificate
active
06203819
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention is related to a unique vitamin, mineral, and herbal supplement for the treatment of both type I and II diabetes, and for the prevention of type II diabetes in those individuals with pre-diabetes, or impaired glucose tolerance (IGT). Specifically, the present invention is directed towards a dietary supplement for diabetic control containing a plurality of compounds from the following group: Vanadyl sulfate, Chromium polynicotinate and picolinate, Magnesium chloride, citrate, fumarate, malate, glutorate, and succinate complex, Natural Vitamin E (free 2R, 4′R, 8′R-alpha tocopherol), Standardized Willow Bark (aspirin), Alpha-lipoic acid, and Folic acid.
Diabetes has become a leading health care issue in the United States and other industrialized countries, accounting for one seventh of the entire national health care product. The incidence of diagnosed diabetes has increased five-fold in America over the past 35 years, with currently 8 million diagnosed diabetic patients, another estimated 8 to 12 million undiagnosed diabetic individuals, and still an additional 23 million Americans with pre-diabetes, or impaired glucose tolerance (IGT). As the American populace continues its strong trend towards aging, obesity and greater minority representation, the increasing rate of diagnosed diabetes is certain to continue.
The tremendous economic and physical toll diabetes extracts from society is, in large part, secondary to both the short and long-term complications of the disease. While there have been great strides made in reducing the short term complications of diabetes, e.g. ketoacidosis, dehydration, and non-ketotic hyperosmolar coma, little, if any, headway has been made in preventing or even minimizing the devastating chronic complications of the disease, e.g. premature atherosclerosis, retinopathy, nephropathy, and neuropathy. Indeed, diabetes has become the leading cause of new cases of blindness in adults in the United States, and now accounts for over a third of all new cases of end-stage renal disease in this country. It is estimated that a diabetic patient's life is shortened by 10 to 15 years, and those years of life are distinguished by a health care tab four times that of a non-diabetic patient.
Diabetes is a major cardiovascular risk factor, especially among women. This increased risk factor in women is a fact lost by many in both the medical and lay communities. Indeed, a man's risk of dying by heart disease doubles when he develops diabetes, but a woman's risk increases three to five-fold the day she is found to have diabetes. The failure to reduce this increased risk for heart disease over the last eight decades of diabetes management is a painful reminder that our current interventions, while having the potential for more favorable impact, are woefully inadequate.
Type II diabetes [(i.e. maturity onset)], which accounts for 95% of diabetes, is far more than just a state of abnormal glucose metabolism, but is rather a milieu of co-existent cardiovascular metabolic risk factors, i.e. insulin resistance, hyperinsulinemia, central obesity, hypertriglyceridemia, low HDL level and elevated blood pressure: a state recently identified as Syndrome X. Much of the excessive cardiovascular morbidity and mortality associated with diabetes is secondary to this array of cardiovascular risk factors, which precede the onset of diabetes by as much as a decade and may explain the presence of overt clinical cardiovascular disease in as many as 60% of newly diagnosed diabetic patients.
However, at least one study revealed 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. The inventor of the present invention has popularized the term “dead zone of diabetes” to describe this phenomenon of increased cardiovascular risk even after allowing for the co-existence of other risk factors in diabetes. This ‘dead zone” is secondary to both the atherogenicity of insulin resistance, which precedes the onset of diabetes by at least 8 years, and the atherogenicity of undiagnosed and uncontrolled hyperglycemia, which is present for 9-12 years before diabetes is first diagnosed. Treatment of diabetes, and its related chronic symptoms and risk factors, are best treated at this early stage.
SCOPE AND CONTENT OF THE PRIOR ART
If the medical community is to have any success in attenuating the cardiovascular ravages of diabetes, it must stress interventions that reduce insulin resistance, an integral part of type II diabetes, and aggressively control blood glucose, through earlier diagnosis and improved management of diabetes. That is precisely why exercise and dietary modification will always be the mainstay of diabetic management, because both will improve insulin sensitivity and glucose control. Until recently the only available pharmacologic (sulfonylureas and insulin) interventions in this country for diabetes, poorly controlled with exercise and diet, did not address insulin resistance and were inappropriate for use in early type II diabetes. Not surprisingly, their use has failed to reduce the excessive car vascular morbidity of diabetes, and, indeed, may even be associated with increased risk of cardiovascular disease.
Therefore, the thrust of the medical and pharmaceutical establishment in recent years has been to introduce (e.g., metformin) to this country or develop drugs (e.g., troglitazone) which act directly to reduce insulin resistance, i.e. insulin sensitizers or enhancers, which hopefully may impact more favorably on the cardiovascular complications of diabetes. Unfortunately, these drugs require a prescription and their use in diabetes is markedly delayed, which will likely blunt their efficacy in reducing cardiovascular risk. Indeed, troglitazone was initially indicated in type II diabetes only in combination with insulin, precluding its use in early diabetes.
Accordingly there is a need for a supplement to control the blood sugar by reducing insulin resistance in diabetic and IGT patients, thereby preventing the chronic complications from developing in these high risk patients. There is also a need to provide an effective supplement for the treatment of diabetes and its symptoms prior to the onset of full-blown diabetes.
SUMMARY OF THE INVENTION
The present invention focuses upon a new and unique dietary supplement specifically formulated for people with diabetes and pre-diabetes (IGT). This formulation is based upon well-designed, randomized, placebo-controlled double-blind human studies, using specific minerals and trace minerals, antioxidant vitamins and acetyl salicylic acid in diabetic subjects. The supplement of the present invention includes the precise (both composition and dosage) bioavailable preparations that have been shown in recent human trials to safely improve blood glucose control, insulin sensitivity, lipid abnormalities, blood pressure, and reduce the risk of heart disease in people with diabetes.
Specifically, the present invention provides a daily nutritional supplement for improving glucose metabolism and insulin action comprising an effective amount of a source of chromium, an effective amount of a source of vanadium, an effective amount of a source of magnesium, vitamin E and aspirin, and an effective amount of folic acid and alpha-lipoic acid.
A preferred supplement includes an effective amount of chromium polynicotinate and chromium picolinate as the chromium source, an effective amount of vanadyl sulfate as the vanadium source, an effective amount of magnesium chloride, citrate, fumarate, malate, glutorate and succinate complex as the magnesium source, an effective amount of free 2R, 4′R, 8′R-alpha tocopherol as the natural Vitamin E source, an effective amount of standardized willow bark as the source of aspirin, an effective amount of folic acid and alpha-lipoic acid, as well as sufficient amounts of vitamin and mineral
Akesis Pharmaceuticals, Inc.
Foley Hoag & Eliot
Jarvis William R. A.
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