Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2000-04-04
2001-11-13
Reamer, James H. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
Reexamination Certificate
active
06316427
ABSTRACT:
The present invention relates to a method of improving glucose tolerance in a human suffering from impaired glucose tolerance (IGT), a prediabetic state, and manifest diabetes Mellitus Type 2.
BACKGROUND OF THE INVENTION
Both IGT and Type 2 diabetes are characterized by insulin resistance. They are parts of a major risk factor complex called the Insulin Resistance Syndrome (IRS). Individuals suffering from IGT or Type 2 diabetes exhibit important changes in diurnal insulin sensitivity, with an enhanced insulin resistance, and in Type 2 diabetes an increased endogenous glucose production at dawn, 4-9 AM. The first meal of the day, usually breakfast, produces a rapid switch from glucose production to glucose utilization. This event takes place under relative hypoinsulinemic conditions in diabetic patients. Both subjects with IGT and Type 2 diabetic patients have decreased carbohydrate tolerance at breakfast. This is also the case with Type 1 diabetic patients, but their postprandial hyperglycemia may be alleviated by an increased dose of exogenous insulin, However, in Type 2 diabetes, where the blood glucose is usually not well controlled by either endogenous or exogenous insulin, a sustained glucose production leads to an accentuated hyperglycemia at breakfast. The elevated nocturnal levels of free fatty acids (FFA) in Type 2 diabetic patients are probably involved in causing the fasting and postprandial hyperglycemia, since breakfast glucose tolerance is improved by FFA suppression using an antilipolytic agent, such as acipimox,
Quite generally, it is known in the art to treat diabetic patients to diminish fluctuations in blood sugar levels and prevent hypoglycemic episodes using slowly absorbed or digested complex carbohydrates, such as natural cornstarch, Thus, U.S. Pat. Nos. 5,605,893 and 5,843,921 to Francine Kaufman are examples of prior art where therapeutic food compositions containing uncooked cornstarch are used in methods of treating diabetic patients. However, the state of the art does not even remotely suggest the use of slow release carbohydrates for improving glucose tolerance in humans suffering from such impaired glucose tolerance prior to or as part of disease in diabetes Mellitus Type 2.
SUMMARY OF THE INVENTION
The main object of the present invention is to provide a method for improving glucose tolerance in a human suffering roam diabetes Mellitus Type 2 or impaired glucose tolerance as a pre-stage of diabetes or obesity.
The method is preferably directed to improving postprandial glucose tolerance.
Yet another object of the invention is to provide such method comprising ingesting a therapeutic amount of slow-release starch, preferably cornstarch, at bedtime.
The invention is based on the surprising discovery that the glucose tolerance in humans suffering from such impaired tolerance can be significantly improved by the ingestion of a therapeutic amount of slow-release starch at bedtime. A preferred starch for such use is natural cornstarch, preferably contained in a palatable carrier.
Such carrier can be constituted by a liquid or a gel or it can be constituted by a carbohydrate other than starch. The carrier can be supplemented with a non-glucose sweetener, such as fructose, sorbitol, maltitol or an artificial sweetener.
Among artificial sweeteners useful in the invention there may be mentioned saccharine, aspartame and acesulfame.
The method according to the invention involves amounts of ingested slow-release carbohydrate varying from about 0.1 to about 1 g per kg bodyweight, especially about 0.2 to about 0.7 g per kg bodyweight.
REFERENCES:
patent: 5605893 (1997-02-01), Kaufman
patent: 5776887 (1998-07-01), Wilbert et al.
patent: 5843921 (1998-12-01), Kaufman
patent: 5866555 (1999-02-01), Bell et al.
“Nocturnal and Postprandial Metabolism in Diabetes Mellitus”, Mette Axelsen, Published: Apr. 8, 1999.
A randomized blinded trial of uncooked cornstarch to diminish nocturnal hypoglycemia at Diabetes Camp, Francine R. Kaufman et al.,Diabetes Research and Clinical Practice,vol. 30, pp. 205 to 209 (1955).
“Use of Uncooked Cornstarch to Avert Nocturnal Hypoglycemia in Children and Adolescents With Type 1 Diabetes”, Francine R. Kaufman et al.,Journal of Diabetes and Its Complications,vol. 10, pp. 84 to 87 (1996).
“Evaluation of a snack bar containing uncooked cornstarch in subjects with diabetes.” Francine R. KaufmanDiabetes Research and Clinical Practice,vol. 35, pp. 27 to 33 (1997).
Axelsen Mette
Smith Ulf
Burns Doane Swecker & Mathis L.L.P.
Reamer James H.
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