TYPE II DIABETES MOLECULAR BIOPROFILE AND METHOD AND SYSTEM OF USING THE SAME

• US 20110136241A1
• Filed: 12/08/2009
• Published: 06/09/2011
• Est. Priority Date: 12/08/2009
• Status: Abandoned Application

• Current Assignee: Stephen Naylor
• Original Assignee: Stephen Naylor
• Inventors: Naylor, Stephen
• Application Number:
  US12/633,205
• Publication Number:
  US 20110136241A1
• Time in Patent Office: Days
• US Class Current: 436/67
• CPC Class Codes: G01N 2800/042 Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
• CPC Class Codes: G01N 2800/60 Complex ways of combining multiple protein biomarkers for diagnosis
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: Y10T 436/144444 Glucose
• CPC Class Codes: Y10T 436/147777 Plural nitrogen in the same ring [e.g., barbituates, creatinine, etc.]
• CPC Class Codes: Y10T 436/201666 Carboxylic acid

Abstract

Molecular bioprofiles comprising biologically correlated and relevant analytes that impact the biological state of a human health condition compared to a control population are provided. These molecular bioprofiles are useful in several ways including but not limited to, monitoring a disease or condition'"'"'s progression, evaluating the impact of an agent or compound on a disease or condition, evaluating the impact of a lifestyle change on a disease or condition and assessing the risk of the disease or condition to a subject. Type II diabetes molecular bioprofiles are of particular interest.

Claims

1. A method of using a Type II diabetes molecular bioprofile comprising the steps of:

(a) analyzing a biological sample from a subject at risk for Type II diabetes, and

(b) preparing a Type II diabetes molecular bioprofile of said subject, wherein said Type II diabetes molecular bioprofile comprises a weighted score for each analyte in a core group of analytes, wherein each weighted score is calculated from a measured concentration of the respective analyte in the biological sample and a respective weighting value.

2. The method of claim 1, wherein said core group of analytes comprises D-glucose, glycated hemoglobin, and insulin.

3. The method of claim 1, wherein said bioprofile further comprises a weighted score for at least one analyte selected from a first priority layer of analytes.

4. The method of claim 3, wherein said first priority layer of analytes comprises cholesterol, HDL, LDL, VLDL, and triglycerides.

5. The method of claim 3, wherein said bioprofile further comprises a weighted score for at least one analyte selected from a second priority layer of analytes.

6. The method of claim 5, wherein said second priority layer of analytes comprises alanine, APOA1, APOB, APOE, arginine, chromium, creatinine, CRP (C-Reactive Protein), ferritin, glycine, IL-6, iron, lactic acid, LEP, lysine, magnesium, phenylalanine, proline, tumor necrosis factor, tyrosine, uric acid, vitamin B9, and zinc.

7. The method of claim 5, wherein said bioprofile further comprises a weighted score for at least one analyte selected from a third priority layer of analytes.

8. The method of claim 7, wherein said third priority layer of analytes comprises ABCA7, Akt, PCSK9, PCYTIA, PEBP4, Epi-androsterone, GBP5, LG11, NFκ

B, NPC1, PI3K, PPP1R13L, RETNLB, SLC12A4, SLC12A7, TRAFD, and UCN3.

9. The method of claim 3 wherein the weighting values of the analytes with said first priority layer of analytes are within a predetermined range.

10. The method of claim 1, wherein the step of preparing the Type II diabetes molecular profile includes calculating a Type II diabetes unified score using the weighted scores.

11. A method of using a Type II diabetes molecular bioprofile comprising the steps of:

(a) analyzing a biological sample from a subject at risk for Type II diabetes, and

(b) preparing a Type II diabetes molecular bioprofile of said subject, wherein said Type II diabetes molecular bioprofile comprises a weighted score for each analyte in a core group of analytes, wherein the weighting value of each analyte in said core group of analytes is in a predetermined range.

12. The method of claim 11, wherein said core group of analytes comprises D-glucose, glycated hemoglobin, and insulin.

13. The method of claim 11, wherein said bioprofile further comprises at least one weighted score for at least one analyte selected from a first priority layer of analytes, wherein the weighting value of each analyte in said first priority layer of analytes is in a predetermined range.

14. The method of claim 13, wherein said first priority layer group of analytes comprises cholesterol, HDL, LDL, VLDL, and triglycerides.

15. The method of claim 11, wherein said bioprofile further comprises at least one weighted score for at least one analyte selected from a second priority layer of analytes, wherein the weighting value of each analyte in said second priority layer of analytes is in a predetermined range.

16. The method of claim 15, wherein said second priority layer of analytes comprises alanine, APOA1, APOB, APOE, arginine, chromium, creatinine, CR, ferritin, glycine, IL-6, iron, lactic acid, LEP, lysine, magnesium, phenylalanine, proline, tumor necrosis factor, tyrosine, uric acid, vitamin B9, and zinc.

17. The method of claim 15, wherein said bioprofile further comprises at least one weighted score for at least one analyte selected from a third priority layer of analytes wherein the weighting value of each analyte in said third priority layer of analytes is in a predetermined range.

18. The method of claim 17, wherein said third priority layer of analytes comprises ABCA7, Akt, PCSK9, PCYTIA, PEBP4, androsterone, GBP5, IL1, LG11, NFκ

B, NPC1, PI3K, PPP1R13L, RETNLB, SLC12A4, SLC12A7, TRAFD, and UCN3.

19-20. -20. (canceled)

21. A method of monitoring Type II diabetes in a subject at risk for Type II diabetes comprising the steps of:

(a) analyzing a first biological sample from a subject at risk for Type II diabetes;

(b) preparing a first Type II diabetes molecular bioprofile of said subject, wherein said first Type II diabetes molecular bioprofile comprises a first weighted score for each analyte in a core group of analytes, wherein each of said first weighted scores is derived from a measurement obtained from said first biological sample and a respective weighting value;

(c) analyzing a second biological sample from said subject;

(d) preparing a second Type II diabetes molecular bioprofile of said subject, wherein said second Type II diabetes molecular bioprofile comprises a second weighted score for each analyte in the core group of analytes, wherein each of said second weighted scores is derived from a measurement obtained from said second biological sample and the respective weighting value; and

(e) monitoring Type II diabetes in said subject as function of said first and second Type II diabetes molecular bioprofiles.

22. The method of claim 21, wherein the step of preparing said first Type II diabetes molecular bioprofile includes calculating a first Type II diabetes unified score using said first weighted scores;

and wherein the step of preparing said second Type II diabetes molecular bioprofile includes calculating a second Type II diabetes unified score using said second weighted scores.

23-29. -29. (canceled)