13C glucose breath test for the diagnosis of diabetic indications and monitoring glycemic control

• US 20040038412A1
• Filed: 05/16/2003
• Published: 02/26/2004
• Est. Priority Date: 05/06/1998
• Status: Active Grant

• Current Assignee: Paladin Labs Inc. (Endo International PLC)
• Original Assignee: Isotechnika Inc. (Endo International PLC)
• Inventors: Foster, Robert T., Yatscoff, Randall W., Lewanczuk, Richard, Aspeslet, Launa J.
• Granted Patent: US 6,878,550 B2
• Time in Patent Office: Days
• US Class Current: 436/56
• CPC Class Codes: A61B 5/0813 Measurement of pulmonary parameters by tracers, e.g. radioactive tracers
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61K 51/1206 Administration of radioactive gases, aerosols or breath tests
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/13 Tracers or tags
• CPC Class Codes: Y10T 436/24 Nuclear magnetic resonance, electron spin resonance or other spin effects or mass spectrometry
• CPC Class Codes: Y10T 436/25875 Gaseous sample or with change of physical state

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.

Claims

10. The use of ¹³C-enriched glucose for the determination of glycemic control in a subject.

11. ¹³C-enriched glucose for use in the manufacture of a diagnostic kit for the determination of glycemic control in a subject.

12. The ¹³C-enriched glucose of claim 11 for use in the manufacture of a diagnostic kit for the detection of diabetes.

13. The ¹³C-enriched glucose of claim 11 for use in the manufacture of a diagnostic kit for the detection of gestational diabetes.

14. The ¹³C-enriched glucose of claim 11 for use in the manufacture of a diagnostic kit for the detection of insulin resistance.

15. The ¹³C-enriched glucose of claim 11 for use in the manufacture of a diagnostic kit for the determination of adequacy of antihyperglycemic therapy.

16. A diagnostic kit for the determination of glycemic control in normal, diabetic and insulin resistant subjects by comparing blood glucose levels with breath levels of ¹³C-enriched CO₂ comprising:

(a) a predetermined quantity of ¹³C-enriched glucose;

(b) a breath collection container; and

(c) a blood sampling device.

17. 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 a first breath collection container;

b) administering 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 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.

18. The method of claim 17, wherein said comparison is made by choosing a cutoff of ROC values wherein the sensitivity and specificity are such as to maximize diagnostic accuracy.

19. The method of claim 18, wherein said condition is insulin resistance and said range of ROC values is 8 to 10.

20. The method of claim 19, said ROC value is 9.

21-1. The method of claim 21, wherein said comparison is made by choosing a cutoff of ROC values wherein the sensitivity and specificity are such as to maximize diagnostic accuracy.