IP Library Granted Patent US 7,723,050
Granted Patent B2
US 7,723,050 · App. 12/501,385 · Granted May 25, 2010

Diabetes-related biomarkers and methods of use thereof

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Quick Facts
Patent No.
US 7,723,050
App. No.
12/501,385
Granted
May 25, 2010
Kind
B2
Abstract

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.

Claims (31)

1. A method of evaluating risk for developing a diabetic condition, the method comprising:

(a) obtaining from at least one biological sample isolated from an individual 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 a 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) reporting said calculated risk to a reporting means comprising a visual display or a printer.

2. A method according to claim 1 further comprising advising said individual or a health care practitioner of said calculated risk.

3. A method according to claim 1 said wherein said biomarkers comprise HBA1C.

4. A method according to claim 1 said wherein said biomarkers comprise Insulin.

5. A method according to claim 3 said wherein said biomarkers comprise Insulin.

6. A method according to claim 1 said wherein said biomarkers further comprise a marker selected from IL2RA (Interleukin 2 Receptor, Alpha) and ferritin.

7. A method according to claim 1 wherein said isolated biological sample is serum or plasma.

8. 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.

9. A method of evaluating risk for developing a diabetic condition, the method comprising:

(a) obtaining from at least one biological sample isolated from an individual 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 a 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) storing said calculated risk on electronic data storage means.

10. A method according to claim 9 further comprising advising said individual or a health care practitioner of said calculated risk.

11. A method according to claim 9 said wherein said biomarkers comprise HBA1C.

12. A method according to claim 9 said wherein said biomarkers comprise Insulin.

13. A method according to claim 11 said wherein said biomarkers comprise Insulin.

14. A method according to claim 9 said wherein said biomarkers further comprise a marker selected from IL2RA (Interleukin 2 Receptor, Alpha) and ferritin.

15. A method according to claim 9 wherein said isolated biological sample is serum or plasma.

16. A method according to claim 9 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 of evaluating risk for developing a diabetic condition, the method comprising:

(a) obtaining from at least one biological sample comprising serum or plasma isolated from an individual 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 a 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) reporting said calculated risk to a reporting means comprising a visual display or a printer;

(d) storing said calculated risk on electronic data storage means; and

(e) advising said individual or a health care practitioner of said calculated risk.

18. A method according to claim 17 said wherein said biomarkers comprise HBA1C.

19. A method according to claim 17 said wherein said biomarkers comprise Insulin.

20. A method according to claim 17 said wherein said biomarkers further comprise a marker selected from IL2RA (Interleukin 2 Receptor, Alpha) and ferritin.

Assignments (8)
SECURITY INTEREST Recorded Jan 31, 2017
From: TRUE HEALTH IP LLC
To: MONROE CAPITAL MANAGEMENT ADVISORS, LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 041575/0879 →
RELEASE OF SECURITY INTEREST Recorded Jan 19, 2017
From: CVF BEADSEA LLC, AS COLLATERAL AGENT
To: HEALTH DIAGNOSTIC LABORATORY, INC.; INTEGRATED HEALTH LEADERS, LLC
Reel/Frame 041013/0469 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 23, 2016
From: TRUE HEALTH DIAGNOSTICS, LLC
To: TRUE HEALTH IP LLC
Reel/Frame 040412/0201 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 22, 2016
From: HEALTH DIAGNOSTIC LABORATORY, INC.
To: TRUE HEALTH DIAGNOSTICS, LLC
Reel/Frame 037787/0300 →
SECURITY INTEREST Recorded Aug 10, 2015
From: HEALTH DIAGNOSTIC LABORATORY, INC.; INTEGRATED HEALTH LEADERS, LLC
To: CVF BEADSEA LLC, AS COLLATERAL AGENT
Reel/Frame 036292/0164 →
RELEASE OF SECURITY INTEREST Recorded Jun 10, 2014
From: HERCULES TECHNOLOGY GROWTH CAPITAL, INC.
To: TETHYS BIOSCIENCE, INC.
Reel/Frame 033114/0137 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 6, 2014
From: TETHYS BIOSCIENCE, INC.
To: HEALTH DIAGNOSTIC LABORATORY, INC.
Reel/Frame 031894/0337 →
SECURITY AGREEMENT Recorded Jul 5, 2012
From: TETHYS BIOSCIENCE, INC.
To: HERCULES TECHNOLOGY GROWTH CAPITAL, INC.
Reel/Frame 028503/0289 →