Protein biopolymer markers predictive of type II diabetes

Abstract

The instant invention involves the use of a combination of preparatory steps in conjunction with mass spectroscopy and time-of-flight detection procedures to maximize the diversity of biopolymers which are verifiable within a particular sample. The cohort of biopolymers verified within such a sample is then viewed with reference to their ability to evidence at least one particular disease state; thereby enabling a diagnostician to gain the ability to characterize either the presence or absence of said at least one disease state relative to recognition of the presence and/or the absence of said biopolymer, predict disease risk assessment, and develop therapeutic avenues against said disease.

1 . A method for diagnosing Type II diabetes comprising: 
 (a) providing a sample; and    (b) determining the presence of a biopolymer marker consisting of SEQ ID NO:4 in said sample;    wherein the presence of said biopolymer marker consisting of SEQ ID NO:4 is diagnostic for Type II diabetes.    
     
     
         2 . The method of  claim 1 , wherein said sample is an-unfractionated body fluid or a tissue sample.  
     
     
         3 . The method of  claim 1 , wherein said sample is selected from the group consisting of blood, blood products, urine, saliva, cerebrospinal fluid, and lymph.  
     
     
         4 . The method of  claim 1 , wherein said sample is obtained from a human patient.  
     
     
         5 . A method for screening for efficacy of disease process modulating agents for Type II diabetes comprising: 
 (a) providing a sample of bodily fluid containing a biopolymer marker consisting of SEQ ID NO:4;    (b) adding a quantity of said agent sufficient to interact with said biopolymer marker consisting of SEQ ID NO:4; and    (c) determining the presence of an interaction between said agent and said biopolymer marker consisting of SEQ ID NO:4;    wherein said interaction is determinative of efficacy of said disease process modulating agent.    
     
     
         6 . A method for diagnosing Type II diabetes by determining the presence of a biopolymer marker consisting of SEQ ID NO:4 comprising: 
 (a) conducting mass spectrometric analysis on a sample obtained from a patient in a manner effective to maximize analysis of peptide fragments contained therein;    (b) comparing a mass spectral profile of said biopolymer marker consisting of SEQ ID NO:4 to mass spectral profiles of peptides obtained and analyzed from said sample; and    (c) confirming the presence of said biopolymer marker consisting of SEQ ID NO:4 in said sample by identifying a mass spectral profile having an ion peak at about 1353 daltons; wherein the presence of said biopolymer marker consisting of SEQ ID NO:4 is diagnostic for Type II diabetes.    
     
     
         7 . The method of  claim 6 , wherein said sample is an unfractionated body fluid or a tissue sample.  
     
     
         8 . The method of  claim 6 , wherein said sample is selected from the group consisting of blood, blood products, urine, saliva, cerebrospinal fluid, and lymph.  
     
     
         9 . The method of  claim 6 , wherein said mass spectrometric analysis is selected from the group consisting of Surface Enhanced Laser Desorption Ionization (SELDI) mass spectrometry, Maldi Qq TOF, MS/MS, TOF-TOF, ESI-Q-TOF and ION-TRAP.  
     
     
         10 . The method of  claim 6 , wherein said patient is a human.