Methods and compositions for the measurement of glucose tolerance

• US 5,122,362 A
• Filed: 12/04/1989
• Issued: 06/16/1992
• Est. Priority Date: 12/04/1989
• Status: Expired due to Fees

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Phillips, William T., Schwartz, Joyce G.
• Primary Examiner(s): Hollrah, Glennon H.
• Assistant Examiner(s): Hollinden, Gary E.
• Application Number:
  US07/445,884
• Time in Patent Office: 925 Days
• Field of Search: 424/9, 514/866
• US Class Current: 435/14
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

The present invention provides methods and compositions for measuring glucose tolerance in a subject. The methods are useful in a variety of contexts, such as in the diagnosis of diabetes in both human and animal subjects, in assessing gastric emptying times, and even in the diagnosis of insulin resistance. It is proposed that the methods of the present invention will prove to be of particular use in the mass screenings of population, e.g., in screening for type II diabetes mellitus, due to its simplicity and reproducibility. The method is even adaptable to simple finger stick analysis. The invention method includes the use of a potable beverage containing a low total loading dose of glucose in a low osmolar solution. The oral glucose solutions of the present invention empty rapidly from the stomach, thereby eliminating the nausea and vomiting typically associated with oral glucose tolerance tests. The oral glucose solutions of the present invention provide a provide excellent reproducibility of results and a distinct separation between nondiabetic and diabetic subjects, thereby enabling clinicians to better diagnose diabetes in a subject.

Claims

1. A method for the diagnosis of diabetes, the method comprising the steps of:

(a) preparing a single aqueous unit dosage oral glucose composition having from about 25 to about 60 grams of glucose, and a concentration ranging from 5 to 14.4% (W/V) glucose, in an aqueous volume of from about about 225 to about 675 milliliters;

(b) orally administering said aqueous unit dosage glucose composition to a subject suspected of having diabetes, the amount administered providing from about 0.35 to about 1.25 grams of glucose per kilogram of body weight to the subject; and

(c) monitoring the blood glucose level in said subject after a predetermined time interval of an hour or less to diagnose diabetes in the subject.

2. The method of claim 1, wherein said unit dosage composition comprises from about 35 to about 50 grams of glucose.

3. The method of claim 2, wherein said unit dosage composition comprises about 50 grams of glucose.

4. The method of claim 1, wherein said unit dosage composition comprises from about 0.50 to about 1.20 grams of glucose per kilogram of body weight of said subject.

5. The method of claim 4, wherein said unit dosage composition comprises from about 0.80 to about 1.10 grams of glucose per kilogram of body weight of said subject.

6. The method of claim 5, wherein said nit dosage composition comprises about 1 gram of glucose per kilogram of body weight of said subject, up to a maximum of 50 grams of glucose per unit dosage.

7. The method of claim 1, wherein said composition further comprises a flavoring agent.

8. The method of claim 1, wherein said subject is an adult human subject.

9. The method of claim 1, wherein the subject is suspected of having type II diabetes.

10. The method of claim 1, wherein said unit dosage glucose composition comprises from about 7% to about 12% glucose (W/V).

11. The method of claim 10, wherein said unit dosage glucose composition comprises from about 10 to about 12% glucose (W/V).

12. The method of claim 11, wherein said unit dosage glucose composition comprises about 11% glucose. (W/V).

13. The method of claim 1, wherein from about 350 to about 550 milliliters of said glucose composition is administered to said subject.

14. The method of claim 13, wherein from about 400 to about 500 milliliters of said glucose composition is administered to said subject.

15. The method of claim 1, wherein said predetermined time interval comprises 30, 45 or 60 minutes following administration of the unit dosage glucose composition.

16. The method of claim 1, wherein a positive diagnosis for diabetics comprises identifying patients who, after ingesting said single unit dosage glucose composition following a period of relative fast, exhibit a peak in their blood glucose level more than thirty minutes following ingestion.

17. The method of claim 1 wherein a negative diagnosis for diabetes comprises identifying patients who after ingesting said single unit dosage glucose composition following a period of relative fast, exhibit a peak in their blood glucose level at thirty minutes or less following ingestion.

18. The method of claim 1, wherein the blood glucose level of the subject is monitored through the use of blood obtained by finger stick.

19. The method of claim 1, wherein said aqueous unit dosage glucose composition is packaged in a unit dosage container.

20. The method of claim 1, wherein an appropriate amount of nonaqueous glucose is prepackaged in a unit dosage container so as to allow the preparation of said aqueous unit dosage composition upon the addition of water.

21. A method for the diagnosis of diabetes, the method comprising the steps of:

(a) preparing a single aqueous unit dosage oral glucose composition having from about 25 to about 60 grams of glucose, and a concentration ranging from 5 to 14.4% (W/V) glucose, in a aqueous volume of from about 225 to about 675 milliliters;

(b) orally administering aqueous unit dosage glucose composition to a subject suspected of having diabetes, the amount administered providing from about 0.35 to about 1.25 grams of glucose per kilogram of body weight to the subject; and

(c) monitoring the blood glucose level in said subject after a predetermined time interval of one hour or less to diagnose diabetes in the subject.

22. A method for the diagnosis of insulin resistance, the method comprising the steps of:

(a) preparing a single aqueous unit dosage oral glucose composition having from about 25 to about 69 grams of glucose, and a concentration ranging from 5 to 14.4% (W/V) glucose, in a aqueous volume of from about 225 to about 675 milliliters;

(b) orally administering said aqueous unit dosage glucose composition to a subject suspected of being insulin resistant, the amount administered providing from about 0.35 to about 1.25 grams of glucose per kilogram of body weight to the subject; and

(c) monitoring the blood glucose level in said subject after a predetermined time interval of one or less to diagnose insulin resistance in the subject.