Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1998-08-04
2002-01-15
Fonda, Kathleen Kahler (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S054000, C514S866000, C424S439000, C424S441000, C426S808000
Reexamination Certificate
active
06339076
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to therapeutic treatments of diabetes mellitus. More particularly, this invention relates to treatment methods and compositions for the prevention of severe fluctuations in blood sugar levels in diabetic patients.
2. Description of the Prior Art
Symptoms of hypoglycemia fall into two main categories. Rapid epinephrine release causes sweating, tremor, tachycardia, anxiety, and hunger. Central nervous system symptoms include dizziness, headache, clouding of vision, blunted mental acuity, confusion, abnormal behavior, convulsions and loss of consciousness. When hypoglycemia is recurrent or severe, nervous system symptoms predominate, and the epinephrine phase may not be recognizable. With more rapid drops or wide swings in plasma glucose (as in insulin reactions), adrenergic symptoms are prominent (
Harrison's Principles of Internal Medicine,
11th Ed., McGraw-Hill Book Company, New York, 1987, p. 1800).
Numerous strategies have been developed to achieve the goal of maintaining blood glucose at a relatively constant level in diabetic patients, such as open looped continuous subcutaneous insulin pumps and multiple daily injections of insulin. These intensive insulin regimens are coupled with home glucose monitoring, and many patients measure their blood glucose levels by finger prick up to 6 to 8 times per day to assure that close to normal blood sugar levels are maintained. This regimen is prescribed because studies have shown that by avoiding excessive high blood sugar levels, the long-term outcome of patients with diabetes can be improved. However, this regimen, which decreases episodes of high blood sugar, also causes patients to experience more low blood sugar reactions (hypoglycemia).
Results of the Diabetes Complication and Control Trial indicate that intensive insulin treatment, while it markedly delays and lessens long term retinal, nephrologic and neuropathic disease, leads to a three to nine-fold increase in hypoglycemic events, most of which occur at night (L. Y. Dawson,
Clinical Diabetes,
11:88-96, 1993). Sometimes these episodes of hypoglycemia are severe and can lead to loss of consciousness and convulsions. Severe hypoglycemic events seem to occur more often at night while the patient is asleep rather than during the day. When awake, diabetic patients can feel hypoglycemic reactions beginning, and can treat themselves with sugar in order to bring their blood sugar levels back into the normal range. When asleep, patients do not have this awareness, and therefore the risk of hypoglycemia is much higher during this time.
The need exists to develop strategies to diminish hypoglycemia while continuing to intensively manage diabetes. Cornstarch has been used effectively to combat the hypoglycemia associated with glycogen storage disease type 1, a disease having an inherited absence or deficiency of glucose-6-phosphatase activity in the liver, kidneys, and intestines, leading to accumulation of glycogen in those organs and hypoglycemia during fasting. Protection against low blood sugar was provided for up to 6 to 8 hours after ingestion of uncooked cornstarch (J. I. Wolfsdorf, et al.,
Am. J. Clin. Nutr.,
51:1051-7, 1990). However, the dosage of cornstarch used for this treatment was 1.75 grams per kilogram of body weight. This dosage is much higher than could be tolerated by a patient with diabetes mellitus.
Another study has also been conducted in patients with diabetes, giving cornstarch during inpatient hospitalization, with a reduction in the nadir of the blood glucose level. Children were fasted and then given the entire carbohydrate content of the standard bedtime snack (30 grams of carbohydrate) as uncooked cornstarch (M. T. Ververs, et al.,
Eur. J. Clin. Nutr.,
47:268-73, 1983). However, in this study the cornstarch did little to prevent hypoglycemia and the researchers did not evaluate varying dosages to determine maximal efficacy.
Thus, the need exists for a better method of treating hypoglycemia in both Type I and Type II diabetics. In particular, a method of treatment or maintenance is required which will avoid serious hypoglycemic episodes while not provoking hyperglycemia.
SUMMARY OF THE INVENTION
Blood glucose levels in patients with diabetes mellitus are regulated and stabilized by administering to the patients a therapeutic food composition including a slowly metabolized complex carbohydrate, preferably uncooked cornstarch; a more rapidly metabolized complex carbohydrate; protein; fat; and fructose or non-sugar sweeteners (e.g., sugar alcohols or artificial sweeteners). The composition is preferably substantially free of simple sugars, but may contain a small quantity (up to 3 grams per unit) of sugars such as sucrose. The composition is slowly absorbed from the gastrointestinal tract and maintains relatively stable blood sugar levels in the diabetic patient for up to nine hours without having any significant adverse effects on the digestive system.
The therapeutic food composition, which may be in the form of a snack bar, is preferably administered to diabetic patients shortly before bedtime, and is effective in substantially preventing nocturnal episodes of hypoglycemia while not causing hyperglycemia.
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Children's Hospital Los Angeles
Fonda Kathleen Kahler
Myers Bigel Sibley & Sajovec P.A.
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