Method for measuring carbohydrate metabolism ability, and composition for use in said method

Abstract

This invention provides a method for measuring glucose metabolism ability of a subject and a composition that is suitably used in the method. The method for measuring glucose metabolism ability of the present invention is as follows: a method for measuring glucose metabolism ability of a subject, using a composition for measuring glucose metabolism ability, the composition comprising, as an active ingredient, glucose labeled with at least one isotope of C, wherein the glucose is converted in the body into labeled carbon dioxide that is excreted in expired air, the method comprising steps (a) and (b) below: (a) administering the composition to the subject and collecting expired air; and (b) determining the ratio of labeled CO 2 amount to unlabeled CO 2 amount or the ratio of labeled CO 2 amount to total CO 2 amount.

1 - 13 . (canceled) 
     
     
         14 . A method for measuring glucose metabolism of a subject comprising:
 (a) administering a composition to the subject and collecting expired air of the subject after the administration of the composition, wherein the composition comprises glucose labeled with at least one isotope of C;   (b) determining a ratio of labeled CO 2  amount to unlabeled CO 2  amount or a ratio of labeled CO 2  amount to total CO 2  amount contained in the expired air of step (a) to generate a subject value;   (c) comparing the subject value, which is “the ratio of labeled CO 2  amount to unlabeled CO 2  amount or the ratio of labeled CO 2  amount to total CO 2  amount” obtained in the subject in step (b), to a control value, which is “a ratio of labeled CO 2  amount to unlabeled CO 2  amount or a ratio of labeled CO 2  amount to total CO 2  amount” of a non-diabetic subject;   (d) detecting that the glucose metabolism of the subject is decreased when the subject value is lower than the control value; and   (e) determining that the subject whose glucose metabolism is determined to be decreased in step (d) is in a stage after onset of diabetes.   
     
     
         15 . The method according to  claim 14 , wherein the subject is in a glucose-loaded state. 
     
     
         16 . The method according to  claim 15 , wherein the glucose-loaded subject has taken, before step (a), a saccharide, a food or beverage comprising a saccharide, or a food or beverage comprising a component that is metabolized to a saccharide. 
     
     
         17 . The method according to  claim 14 , wherein the non-diabetic subject is a subject in which diabetes has not developed, and that is not in a stage before onset of diabetes. 
     
     
         18 . A method for measuring glucose metabolism of a subject comprising:
 (a) administering a composition to the subject and collecting expired air of the subject after the administration of the composition, wherein the composition comprises glucose labeled with at least one isotope of C;   (b) determining a ratio of labeled  13 CO 2  amount to unlabeled CO 2  amount or a ratio of labeled  13 CO 2  amount to total CO 2  amount contained in the expired air of step (a);   (c) providing a Δ 13 C value (‰)-expired air collection time t curve (Δ 13 C(‰)AUC t )] or a Δ 13 C(‰);   (d) determining, as an index of glucose metabolism of the subject, a correlation between a predetermined blood glucose level of the subject and a value obtained by dividing [an area under the Δ 13 C(‰)-expired air collection time t curve (Δ 13 C(‰)AUC t )] or a Δ 13 C(‰) value at at least one point in time (t) after administration of the composition (Δ 13 C(‰) t ) by a predetermined insulin concentration of the subject (“Δ 13 C(‰)AUC t /insulin” or “Δ 13 C(‰) t /insulin”); and   (e) identifying from the correlation of the glucose metabolism of the subject whether the subject is at a stage before or a stage after onset of diabetes as distinguished from a non-diabetic subject.   
     
     
         19 . The method according to  claim 18 , wherein the “Δ 13 C(‰)AUC t /insulin” or “Δ 13 C(‰) t /insulin” of the subject is lower than the “Δ 13 C(‰)AUC t /insulin” or “Δ 13 C(‰) t /insulin” of a non-diabetic subject. 
     
     
         20 . The method according to  claim 18 , wherein the non-diabetic subject is a subject in which diabetes has not developed, and that is not in a stage before onset of diabetes. 
     
     
         21 . A method for detecting a stage after onset of diabetes in a subject comprising using, as an index, glucose metabolism of the subject obtained by a method for measuring glucose metabolism of a subject comprising:
 (a) administering a composition to the subject and collecting expired air of the subject after the administration of the composition, wherein the composition comprises glucose labeled with at least one isotope of C; and   (b) determining a ratio of labeled CO 2  amount to unlabeled CO 2  amount or a ratio of labeled CO 2  amount to total CO 2  amount contained in the expired air of step (a) to generate a subject value; and   (c) comparing the subject value, which is “the ratio of labeled CO 2  amount to unlabeled CO 2  amount or the ratio of labeled CO 2  amount to total CO 2  amount” obtained in the subject in step (b), to a control value, which is “a ratio of labeled CO 2  amount to unlabeled CO 2  amount or a ratio of labeled CO 2  amount to total CO 2  amount” of a non-diabetic subject, wherein when the subject value is lower than the control value, the glucose metabolism of the subject is decreased; and   (d) determining that the subject is in a stage after onset of diabetes when the subject's glucose metabolism is decreased.   
     
     
         22 . The method according to  claim 21 , wherein the expired air is collected at least at one point in time within 120 minutes after administration of the composition to the subject. 
     
     
         23 . The method according to  claim 21 , wherein the expired air is collected at least at one point in time within 60 minutes after administration of the composition to the subject. 
     
     
         24 . The method according to  claim 21 , wherein the expired air is collected at least at one point in time within 30 minutes after administration of the composition to the subject. 
     
     
         25 . The method according to  claim 21 , wherein the non-diabetic subject is a subject in which diabetes has not developed, and that is not in a stage before onset of diabetes. 
     
     
         26 . A method for detecting and monitoring over time a drug treatment effect for diabetes on a diabetic subject, comprising:
 (a) administering a composition to the subject before and after the drug treatment for diabetes;   (b) collecting expired air of the subject before and after the drug treatment for diabetes after the composition has been administered to the subject, wherein the composition comprises glucose labeled with at least one isotope of C;   (c) determining a ratio of labeled  13 CO 2  amount to unlabeled CO 2  amount contained in the expired air before and after the drug treatment for diabetes, or a ratio of labeled  13 CO 2  amount to total CO 2  amount contained in the expired air before and after the drug treatment for diabetes to generate a subject value; and   (d) comparing the subject value, which is “the ratio of labeled  13 CO 2  amount to unlabeled CO 2  amount contained in the expired air or the ratio of labeled CO 2  amount to total CO 2  amount contained in the expired air” (Δ% 13 C(atom %) or Δ 13 C value(‰)) obtained in the subject after the drug treatment for diabetes in step (c) to a control value, which is “the corresponding ratio of labeled  13 CO 2  amount to unlabeled CO 2  amount contained in the expired air or the corresponding ratio of labeled CO 2  amount to total CO 2  amount contained in the expired air” (Δ% 13 C(atom %) or Δ 13 C value(‰)) obtained in the subject before the drug treatment for diabetes in step (c), and   (e) determining that the drug treatment for diabetes is effective in the subject when the subject value is higher than the control value, or that the drug treatment for diabetes is not effective in the subject when the subject value is the same as or lower than the control value.