Diabetes-related biomarkers and methods of use thereof
View Patent ↗The invention describes biomarkers which can be used to predict the likelihood that an individual will develop Diabetes. The biomarkers can also be used to screen large groups in order to identify individuals at risk of developing Diabetes.
1. A method for monitoring a treatment regimen to delay or prevent an individual's conversion to a frank Diabetes disease state, the method comprising:
(a) obtaining from at least one biological sample isolated from said individual undergoing said treatment regimen measurements of biomarkers comprising the biomarkers ADIPOQ (Adiponectin), GLUCOSE and CRP (C-Reactive Protein), and further comprising at least one biomarker selected from the group consisting of HBA1C (Glycosylated Hemoglobin), IGFBP1 (Insulin-like growth factor binding protein 1), IGFBP2 (Insulin-like growth factor binding protein 2), Insulin, LEP (Leptin) and TRIG (Triglycerides);
(b) calculating the individual's risk for developing a diabetic condition from the output of a model, wherein the inputs to said model comprise said measurements, and further wherein said model was developed by fitting data from a longitudinal study of a selected population of individuals and said fitted data comprises levels of said biomarkers and conversion to Diabetes in said selected population of individuals; and
(c) comparing the calculated risk for said individual to a previously calculated risk obtained from at least one earlier sample from said individual.
2. A method according to claim 1 wherein at least one of said biomarker measurements is obtained by a method selected from the group consisting of immunoassay and enzymatic activity assay.
3. A method according to claim 1 further comprising advising said individual or a health care practitioner of said change in calculated risk.
4. A method according to claim 2 further comprising advising said individual or a health care practitioner of said change in calculated risk.
5. A method according to claim 1 wherein said biomarkers comprise HBA1C.
6. A method according to claim 2 wherein said biomarkers comprise HBA1C.
7. A method according to claim 1 wherein said biomarkers comprise Insulin.
8. A method according to claim 2 wherein said biomarkers comprise Insulin.
9. A method according to claim 5 wherein said biomarkers further comprise Insulin.
10. A method according to claim 6 wherein said biomarkers further comprise Insulin.
11. A method according to claim 1 wherein said biomarkers further comprise a marker selected from IL2RA (Interleukin 2 Receptor, Alpha) and ferritin.
12. A method according to claim 2 wherein said biomarkers further comprise a marker selected from IL2RA (Interleukin 2 Receptor, Alpha) and ferritin.
13. A method according to claim 1 wherein said isolated biological sample is serum or plasma.
14. A method according to claim 2 wherein said isolated biological sample is serum or plasma.
15. A method for monitoring a treatment regimen or to delay, or prevent an individual's conversion to a frank Diabetes disease state, the method comprising:
(a) obtaining from at least one biological sample isolated from said individual undergoing said treatment regimen measurements of biomarkers comprising the biomarkers ADIPOQ (Adiponectin), GLUCOSE and CRP (C-Reactive Protein), and further comprising at least one biomarker selected from the group consisting of HBA1C (Glycosylated Hemoglobin), IGFBP1 (Insulin-like growth factor binding protein 1), IGFBP2 (Insulin-like growth factor binding protein 2), Insulin, LEP (Leptin) and TRIG (Triglycerides);
(b) calculating the individual's risk for developing a diabetic condition from the output of a model, wherein the inputs to said model comprise said measurements, and further wherein said model was developed by fitting data from a longitudinal study of a selected population of individuals and said fitted data comprises levels of said biomarkers and conversion to Diabetes in said selected population of individuals;
(c) storing said calculated risk on electronic data storage means
(d) comparing the calculated risk for said individual to a previously calculated risk obtained from at least one earlier sample from said individual.
16. A method according to claim 15 wherein at least one of said biomarker measurements is obtained by a method selected from the group consisting of immunoassay and enzymatic activity assay.
17. A method according to claim 15 further comprising advising said individual or a health care practitioner of said change in calculated risk.
18. A method according to claim 16 further comprising advising said individual or a health care practitioner of said change in calculated risk.
19. A method according to claim 15 wherein said biomarkers comprise HBA1C.
20. A method according to claim 16 wherein said biomarkers comprise HBA1C.
21. A method according to claim 15 wherein said biomarkers comprise Insulin.
22. A method according to claim 16 wherein said biomarkers comprise Insulin.
23. A method according to claim 19 wherein said biomarkers further comprise Insulin.
24. A method according to claim 20 wherein said biomarkers further comprise Insulin.
25. A method according to claim 15 wherein said biomarkers further comprise a marker selected from IL2RA (Interleukin 2 Receptor, Alpha) and ferritin.
26. A method according to claim 16 wherein said biomarkers further comprise a marker selected from IL2RA (Interleukin 2 Receptor, Alpha) and ferritin.
27. A method according to claim 15 wherein said isolated biological sample is serum or plasma.
28. A method according to claim 16 wherein said isolated biological sample is serum or plasma.
29. A method for monitoring a treatment regimen to delay or prevent an individual's conversion to a frank Diabetes disease state, the method comprising:
(a) obtaining from at least one biological sample isolated from said individual undergoing said treatment regimen measurements of biomarkers comprising the biomarkers ADIPOQ (Adiponectin), GLUCOSE and CRP (C-Reactive Protein), and further comprising at least one biomarker selected from the group consisting of HBA1C (Glycosylated Hemoglobin), IGFBP1 (Insulin-like growth factor binding protein 1), IGFBP2 (Insulin-like growth factor binding protein 2), Insulin, LEP (Leptin) and TRIG (Triglycerides);
(b) calculating the individual's risk for developing a diabetic condition from the output of a model, wherein the inputs to said model comprise said measurements, and further wherein said model was developed by fitting data from a longitudinal study of a selected population of individuals and said fitted data comprises levels of said biomarkers and conversion to Diabetes in said selected population of individuals;
(c) storing said calculated risk on electronic data storage means
(d) comparing the calculated risk for said individual to a previously calculated risk obtained from at least one earlier sample from said individual and
(f) advising said individual or a health care practitioner of whether there has been a change in calculated risk.
30. A method according to claim 20 wherein at least one of said biomarker measurements is obtained by a method selected from the group consisting of immunoassay and enzymatic activity assay.
31. A method according to claim 20 wherein said biomarkers comprise HBA1C.
32. A method according to claim 30 wherein said biomarkers comprise HBA1C.
33. A method according to claim 20 wherein said biomarkers comprise Insulin.
34. A method according to claim 30 wherein said biomarkers comprise Insulin.
35. A method according to claim 20 wherein said biomarkers further comprise a marker selected from IL2RA (Interleukin 2 Receptor, Alpha) and ferritin.
36. A method according to claim 30 said wherein said biomarkers further comprise a marker selected from IL2RA (Interleukin 2 Receptor, Alpha) and ferritin.
37. A method according to claim 20 wherein said isolated biological sample is serum or plasma.
38. A method according to claim 30 wherein said isolated biological sample is serum or plasma.