Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heavy metal containing doai
Reexamination Certificate
2001-09-20
2004-10-26
Leith, Patricia (Department: 1654)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heavy metal containing doai
C514S492000, C514S558000
Reexamination Certificate
active
06809115
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The disclosed invention related to compositions and methods for the treatment of type 1 diabetes, reduction of body fat, improvement of insulin sensitivity, reduction of hyperglycemia, and reduction of hypercholesterolemia. Specifically, compositions comprising chromium complexes in combination with conjugated compounds such as isomers of conjugated fatty acids or conjugated fatty alcohols.
2. Description of the Related Art
Insulin-Dependent Diabetes
Diabetes is a chronic metabolic disorder which afflicts 16 million people in the United States, over one and one half million of whom have its most severe form, childhood diabetes (also called juvenile, type 1 or insulin-dependent diabetes). Insulin-dependent diabetes appears suddenly, most often in children and young adults, and progresses rapidly. In this form, the pancreas ceases to manufacture insulin, a hormone necessary to convert the food we eat into energy for the body. In the United States, diabetes is the fourth leading cause of death, killing more than 162,000 people each year. Notably, the mortality rate of patients with insulin-dependent diabetes increases dramatically after 15 years of disease duration. In addition, virtually every major organ system in the body is damaged by diabetes. Complications can include blindness, kidney failure, heart disease, stroke, amputation of extremities, loss of nerve sensation, early loss of teeth, high-risk pregnancies and babies born with birth defects.
Insulin resistance is characterized by reductions of glucose uptake in skeletal muscle. Currently, insulin injection is the only treatment method available for the over 1.5 million type 1 diabetics and becomes the eventual course of treatment for many of the more than 16 million type 2 diabetics in the United States. Nutritional therapies that positively impact glucose uptake in the face of insulin insufficiency would have a major impact on the long term treatment costs associated with diabetic care.
Obesity
More than half of U.S. adults are overweight and nearly one-quarter of the U.S. adults are considered to be obese. The increasing prevalence of overweight and obesity is a major public health concern, since obesity is associated with several chronic diseases. For example, overweight and obesity are known risk factors for diabetes, heart disease, stroke, hypertension, gallbladder disease, osteoarthritis, sleep apnea, and some forms of cancer such as uterine, breast, colorectal, kidney, and gallbladder. Furthermore, obesity is associated with high cholesterol, complications of pregnancy, menstrual irregularities, hirsutism, and increased surgical risk.
Drugs currently approved by the FDA for the treatment of obesity produce weight losses of about 10% of initial body weight at one year when used singly. Combination therapy with phentermine and fenfluramine produced weight losses of about 15% of initial body weight at one year. Phenylpropanolamine (PPA) is an over-the-counter drug that has not been tested for long term use and is recommended for use for only about 12 weeks. With the exception of PPA, all of these drugs require a physician's prescription and are generally quite expensive. Side effects occur with all these drugs. For example, the administration of fenfluramine and phentermine for the treatment of obesity resulted in cardiac valve damage in some patients and ultimately led to the withdrawal of fenfluramine from the market. Two of the newest drugs for the treatment of obesity have side effects that limit their use. Sibutramine increases blood pressure in a subset of patients, and orlistat may have unpleasant gastrointestinal side effects.
The Role of Chromium Complexes in the Treatment of Insulin-Dependent Maladies
Chromium picolinate is reported to produce modest weight loss and changes in body composition (Kaats, 1998, Cefalu, 1999). Chromium is a nutritionally essential trace element. The essentiality of chromium in the diet was established in 1959 by Schwartz, as cited in
Present Knowledge in Nutrition
, page 571, fifth edition (1984, the Nutrition Foundation, Washington, D.C.). Chromium depletion is characterized by the disturbance of glucose, lipid and protein metabolism and by a shortened lifespan. Chromium is essential for optimal insulin activity in all known insulin-dependent systems (Boyle et alN.,
Southern Med. J.
70:1449-1453, 1977). Insufficient dietary chromium has been linked to both maturity-onset diabetes and to cardiovascular disease.
The principal energy sources for the body are glucose and fatty acids. Chromium depletion results in biologically ineffective insulin and compromised glucose metabolism. Under these conditions, the body must rely primarily on lipid metabolism to meet its energy requirements, resulting in the production of excessive amounts of acetyl-CoA and ketone bodies. Some of the documented acetyl-CoA is diverted to increased cholesterol biosynthesis, resulting in hypercholesterolemia. Diabetes mellitus is characterized in large part by glycosuria, hypercholesterolemia, and often ketoacidosis. The accelerated atherosclerotic process seen in diabetics is associated with hypercholesterolemia (Boyle et al., supra.).
Dietary supplementation of chromium to normal individuals has been reported to lead to improvements in glucose tolerance, serum lipid concentrations, including high-density lipoprotein cholesterol, insulin and insulin binding (Anderson,
Clin. Psychol Biochem.
4:31-41, 1986). Supplemental chromium in the trivalent form, e.g. chromic chloride, is associated with improvements of risk factors associated with adult-onset (type 2) diabetes and cardiovascular disease.
Chromium functions as a cofactor for insulin. It binds to the insulin receptor and potentiates many, and perhaps all, of its functions (Boyle et al., supra.). These functions include, but are not limited to, the regulation of carbohydrate and lipid metabolism. (
Present Knowledge in Nutrition
, supra, at p. 573-577). The introduction of inorganic chromium compounds per se into individuals is not particularly beneficial. Chromium must be converted endogenously into an organic complex or must be consumed as a biologically active molecule. Only about 0.5% of ingested inorganic chromium is assimilated into the body (
Recommended Daily Allowances
, Ninth Revised Edition, The National Academy of Sciences, page 160, 1980). Only 1-2% of most organic chromium compounds are assimilated into the body.
U.S. Pat. No. Re. 33,988 discloses that when selected essential metals, including chromium, are administered to mammals as exogenously synthesized coordination complexes of picolinic acid, they are directly available for absorption without competition from other metals. This patent describes a composition and method for selectively supplementing the essential metals in the human diet and for facilitating absorption of these metals by intestinal cells. These complexes are safe, inexpensive, biocompatible and easy to produce. These exogenously synthesized essential metal coordination complexes of picolinic acid (pyridine-2-carboxylic acid) have the following structural formula:
wherein M represents the metallic cation and n is equal to the cation's valence. For example, when M is Cr and n=3, then the compound is chromic tripicolinate. Other chromium picolinates disclosed include chromic monopicolinate and chromic dipicolinate.
The U.S. Recommended Daily Intake (RDI) of chromium is 120 &mgr;g. U.S. Pat. No. 5,087,623, the entire contents of which are hereby incorporated by reference, describes the administration of chromic tripicolinate for the treatment of adult-onset diabetes in doses ranging from 50 to 500 &mgr;g. International Patent Application No. WO96/35421 discloses the use of high doses of chromic tripicolinate (providing 1,000-10,000 &mgr;g chromium/day) for reducing hyperglycemia and stabilizing the level of serum glucose in humans with type 2 diabetes. U.S. Pat. No. 5,789,401 discloses a chromic tripicolinate-biotin composition and its use in low
Greenberg Danielle
Katz David P.
Komorowski James R.
Knobbe Martens Olson & Bear LLP
Leith Patricia
Nutrition 21, Inc.
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