Methods, products and treatments for diabetes

Abstract

The invention involves assays, diagnostics, kits, and assay components for determining levels of K41-glycated CD59 in subjects. Treatments for subjects based upon levels of K41-glycated CD59 also are provided.

We Claim: 
     
         1 . A fragment of K41-glycated CD59, wherein the fragment comprises at least 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 contiguous amino acids having a consecutive sequence found in CD59 and including K41, wherein K41 is glycated. 
     
     
         2 . The fragment of  claim 1 , wherein the consecutive sequence begins at any one of amino acids 22-36 of K41-glycated CD59 and ends at any one of amino acids 50-60 of K41-glycated CD59. 
     
     
         3 . The fragment of  claim 1 , wherein the fragment comprises at least 15 contiguous amino acids. 
     
     
         4 . The fragment of  claim 1 , wherein the fragment is pure or isolated. 
     
     
         5 . The fragment of  claim 1 , wherein CD59 is human CD59. 
     
     
         6 . A peptide comprising the sequence: YNKAWKFEHANFNDC (SEQ ID NO: 1). 
     
     
         7 . The peptide of  claim 6 , wherein the peptide comprises SEQ ID NO: 1, wherein:
 the N-terminus of SEQ ID NO: 1 is blocked to prevent glycation thereon; and   the amino acid of SEQ ID NO: 1 corresponding to K38 of CD59 is blocked to prevent glycation thereon.   
     
     
         8 . A method of evaluating a treatment for regulating blood sugar levels, the method comprising:
 obtaining a first level of K41-glycated CD59 from a first sample obtained from a subject undergoing treatment for regulating blood sugar levels;   obtaining a second level of K41-glycated CD59 from a second sample obtained from the subject after obtaining the first level; and   comparing the first level to the second level as an indication of evaluation of the treatment.   
     
     
         9 . The method of  claim 8 , wherein the subject is a human. 
     
     
         10 . The method of  claim 8 , wherein the first and second samples are body fluid samples. 
     
     
         11 . The method of  claim 8 , wherein the first and second samples are urine, saliva, sweat, or blood. 
     
     
         12 . The method of  claim 8 , wherein the first and second levels are obtained using an immunoassay. 
     
     
         13 . The method of  claim 12 , wherein the immunoassay is selected from the group consisting of sandwich-type assays, competitive binding assays, one-step direct tests, and two-step tests. 
     
     
         14 . The method of  claim 12 , wherein the immunoassay employs an antibody, or antigen-binding fragment thereof, that specifically binds K41-glycated CD59. 
     
     
         15 . The method of  claim 12 , wherein the immunoassay employs a first antibody or antigen-binding fragment thereof that binds both K41-glycated and K41-nonglycated CD59 and a second antibody or antigen-binding fragment thereof that binds only one of K41-glycated and K41-nonglycated CD59. 
     
     
         16 . The method of  claim 8 , wherein:
 the first level is obtained as a percentage of the total CD59 in the first sample; and   the second level is obtained as a percentage of the total CD59 in the second sample.   
     
     
         17 . The method of  claim 8 , wherein:
 the first level is the level of K41-glycated CD59 relative to the level of K41-nonglycated CD59 in the first sample; and   the second level is the level of K41-glycated CD59 relative to the level of K41-nonglycated CD59 in the second sample.   
     
     
         18 . The method of  claim 8 , wherein the treatment is an oral blood sugar regulating agent, an insulin therapy, or insulin analog therapy. 
     
     
         19 . A method of selecting a treatment for regulating blood sugar levels in a subject, the method comprising:
 obtaining a level of the amount of K41-glycated CD59 from a sample obtained from the subject; and   selecting the treatment for regulating blood sugar levels in the subject based at least in part on the level obtained.   
     
     
         20 . The method of  claim 19 , wherein the subject has not received and is not undergoing a therapy for regulating blood sugar levels.