13C glucose breath test for the diagnosis of diabetic indications and monitoring glycemic control
First Claim
Patent Images
1. A diagnostic kit for the determination of glycemic control in a subject comprising:
- (a) a predetermined quantity of uniformly labeled 13C-enriched glucose; and
(b) a plurality of breath collection containers.
5 Assignments
0 Petitions
Accused Products
Abstract
Use of 13C glucose in an analytical assay to monitor glucose metabolism by measurement of labeled exhaled CO2 is provided. A breath test and kit for performing the breath test are described for the diagnosis of diabetic indications and monitoring of glycemic control. The breath test utilizes the measurement of expired 13C-labeled CO2 following the ingestion of a 13C-enriched glucose source.
-
Citations
29 Claims
-
1. A diagnostic kit for the determination of glycemic control in a subject comprising:
-
(a) a predetermined quantity of uniformly labeled 13C-enriched glucose; and
(b) a plurality of breath collection containers. - View Dependent Claims (2, 3, 4, 5, 6, 7)
-
-
8. A diagnostic kit for the determination of glycemic control in normal, diabetic and insulin resistance subjects by comparing blood glucose levels with breath levels of 13C-enriched CO2 comprising:
-
(a) a predetermined quality of uniformly labeled 13C-enriched glucose;
(b) a plurality of breath collection containers; and
(c) a blood sampling device.
-
-
9. A method of diagnosing a condition in a subject, said condition selected from the group consisting of diabetes, insulin resistance impaired glucose tolerance, impaired fasting glucose and gestational diabetes, said method comprising:
-
a) collecting a first breath sample from said subject in first breath collection container;
b) administering uniformly labeled 13C-enriched glucose to said subject;
c) collecting a second breath sample from said subject in a second breath container at a time point after administration of said uniformly labeled 13C-enriched glucose;
d) measuring the 13CO2 in each of said first and second breath samples; and
e) comparing the amount of 13CO2 in said second breath sample with the amount of 13CO2 in said first breath sample, wherein the presence of less 13CO2 in said second breath sample compared to normal control values indicates the presence of said condition. - View Dependent Claims (10, 11, 12)
-
-
13. A method of predicting a subject'"'"'s risk of developing diabetes, said method comprising:
-
a) collecting a first breath sample from said subject in a first breath collection container;
b) administering uniformly labeled 13C-enriched glucose to said subject;
c) collecting a second breath sample from said subject in a second breath container at a time point after administration of said uniformly labeled 13C-enriched glucose;
d) measuring the 13CO2 in each of said first and second breath samples; and
e) comparing the amount of 13CO2 in said second breath sample with the amount of 13CO2 in said first breath sample, wherein the presence of less 13CO2 in said second breath sample compared to normal control values indicates risk of developing diabetes. - View Dependent Claims (14, 15, 16, 20)
-
-
17. A diagnostic kit for the diagnosis of insulin resistance in a subject comprising:
-
(a) a predetermined quantity of uniformly labeled 13C-enriched glucose; and
(b) a breath collection container. - View Dependent Claims (18, 19, 21, 22)
-
-
23. A diagnostic kit for monitoring antihyperglycemic therapy in a subject comprising:
-
(a) a predetermined quantity of uniformly labeled 13C-enriched glucose; and
(b) a breath collection container. - View Dependent Claims (24, 25, 26, 27)
-
-
28. A method of diagnosing insulin resistance in subject, said method comprising:
-
a) collecting a first breath sample from said subject in a first breath collection container;
b) administering uniformly labeled 13C-enriched glucose to said subject;
c) collecting a second breath sample from said subject in a second breath container at a time point after administration of said uniformly labeled 13C-enriched glucose;
d) measuring the 13CO2 in each of said first and second breath samples;
e) comparing the amount of 13CO2 in said second breath sample with the amount of 13CO2 in said first breath sample to calculate a delta over baseline; and
f) diagnosing insulin resistance if the calculated delta over baseline for the subject is less than a standard delta over baseline of a normal individual or of a typical diabetic individual.
-
-
29. A method of diagnosing insulin resistance in a subject, said method comprising:
-
a) collecting a first breath sample from the subject in a first breath collection container;
b) administering uniformly labeled 13C-enriched glucose to the subject;
c) collecting a second breath sample from the subject in a second breath container at a first time point after administration of the uniformly labeled 13C-enriched glucose;
d) collecting a third breath sample from the subject in a third breath container at a second time point after administration of the uniformly labeled 13C-enriched glucose;
e) measuring the 13CO2 in each of the first, second and third breath samples to generate a breath test curve;
f) determining a blood glucose level of the subject prior to administration of the uniformly labeled 13C-enriched glucose and at the first and second time point after administration to generate a blood glucose test curve;
g) diagnosing insulin resistance if the area between the breath test curve and the blood glucose test curve is less than that of a standard individual or of a typical diabetic individual.
-
Specification