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Biomarkers and assays for diabetes

A biomarker, diabetes technology, used in assays and data evaluation for the detection and monitoring of diabetes, detection and monitoring of diseases or disorders, and can solve problems such as different assay protocols

Inactive Publication Date: 2011-08-31
兰德尔·W·尼尔森 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Both markers can be measured using a single clinical assay platform (eg, Beckman Coulter SYNCHRON), but each requires a different assay protocol

Method used

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  • Biomarkers and assays for diabetes
  • Biomarkers and assays for diabetes
  • Biomarkers and assays for diabetes

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0056] Subjects with disease: healthy, type 2 diabetes mellitus (T2DM) and insulin-dependent Type 2 diabetes mellitus (id T2DM )

[0057] Given below is a comparison of healthy individuals (not known to have the disease; n=50), T2DM individuals (diagnosed with T2DM and treated with usual diet, exercise, and non-insulin medications; n=37) and id-T2DM individuals (dependent Examples of genetic variants, post-translational modifications, and metabolic changes obtained from primary screening of a population diagnosed with T2DM and treated with insulin administration; n=15) based on insulin. EDTA-plasma samples (with informed consent and IRB approval) were collected from these individuals after an 8-hour fast and stored at -70°C until analysis using the method described below. Records of gender, race, BMI, medication history, and current treatment were also obtained from each diabetic patient.

example 2

[0059] Population proteomics and T2DM

[0060] Table 1 shows an exemplary list of 15 bloodborne markers (proteins & protein variants), each capable of distinguishing healthy from T2DM subjects. It is important to note that markers are due to the relative modulation of PTMs associated with physiological pathways known to be affected in T2DM diagnosis or treatment.

[0061]

[0062]

[0063] Hemoglobin MSIA detects HbAlc and the second PTM of the hemoglobin B-chain (at +120 Da) and glycation of the A-chain (+162 Da). Differences in the degree of oxidation were detected as depletion of the native form versus all variant forms (eg, cysteinated at +119 Da). This assay was also used to monitor (simultaneous) glycation differences. The difference in oxidation is the increased sulfonation (+80Da) that occurs at cys10. Oxidation occurs at methionine (+16Da to +48Da). Percentages reflect total oxidative capacity. Apo C1 has two forms, intact and truncated at the n-terminal ...

example 3

[0069] Gc-globulin (also known as vitamin D-binding protein): genetic variation and post-translational modify

[0070] Gc-globulin or GcG (also known as the vitamin D binding protein) is a plasma protein with a nominal molecular weight of ~51 kDa and its estimated concentration in plasma is 200-600 mg / L. It is known that there are three high-frequency allelic variants, Gc-1F, Gc-1S and Gc-2, and other low-frequency variants in the human population. For GcG, major physiological roles include vitamin D metabolite transport, fatty acid transport, actin sequestration, and macrophage activation. Variations in this protein can thus constitute physiological events resulting in Widesweeping.

[0071] During the study, genetic and dominant variants were analyzed from blood plasma using immunoassay extraction followed by electrospray mass spectrometry (ESI-MS). Human plasma samples (125 μL) were diluted two-fold in HEPES buffered saline (HBS) and placed into 96-well titer plates. ...

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Abstract

The present invention is directed to novel biomarkers and combinations thereof. The present invention also provides assays and data evaluation methods related to the detection and monitoring of diseases, particularly, diabetes. In particular, the biomarkers in accordance with the present invention include, but are not limited to, modified forms of nominally wild-type proteins, such as Gc-Globulin or GcG (also known as Vitamin D binding protein), beta-2-microglobulin (b2m), cystatin C (cysC), Albumin and Hem A&B. Particular forms of diabetes contemplated by the methods of the present invention include, but are not limited to, type 1 diabetes (T1D), type 2 diabetes (T2DM), pre-T1D and pre-T2DM. The present invention also provides methods of detecting multiple biomarkers in a single assay and to employ data evaluation methods that is able to accurately use these data in the determination and monitoring of diseases, such as diabetes.

Description

Background of the invention [0001] It is estimated that nearly 24 million Americans have diabetes (type 1 and type 2 overall), and approximately one-third of these individuals do not know they have the disease. Diabetes is conservatively estimated to be the sixth leading cause of death in the United States and is found to be disproportionately prevalent (with a larger percentage) in a minority population. Increasing at a rate of approximately 50% over the decade from 1990 to 2000, diabetes is estimated to double in prevalence over the next forty years and is considered in part to be a global threat to race, leading to increased mortality , decreased quality of life and increased health care costs. In 2007, the total cost of diabetes care was estimated to be $174 billion, with medical expenditures alone accounting for the majority of the total. Diabetes causes 12,000-24,000 new cases of blindness each year and is an inducer of renal failure, resulting in approximately 150,000...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/50
CPCG01N2333/775G01N2800/042G01N2333/8139G01N33/6893G01N2333/4713G01N2333/76G01N2333/62G01N2333/805
Inventor 兰德尔·W·尼尔森查德·R·博格斯
Owner 兰德尔·W·尼尔森