Biomarkers for Differentiating Between Type 1 and Type 2 Diabetes

Abstract

Biomarkers that are diagnostic of type 1 diabetes, type 2 diabetes and/or diabetic disorder are identified. Detection of different biomarkers of the invention are also diagnostic of the degree of severity of type 1 diabetes, type 2 diabetes and/or diabetic disorder. An analysis includes the parameters of matching for BMI and Tanner stage. Receiver-operator characteristic (ROC) curves were established to assess association of the biomarkers with a disease.

1 . A method for differentiating between type 1 and type 2 diabetes in a subject, the method comprising the steps of:
 (a) obtaining a sample from the subject;   (b) determining the amount of at least one biomarker in the sample; and   (c) correlating the amount of said biomarker in the sample with the presence of either type 1 and type 2 diabetes in the subject.   
   
   
       2 . The method of  claim 1 , wherein the levels of at least two biomarkers in the sample are determined and extrapolated into a ratio and the ratio is correlated with the presence of either type 1 or type 2 diabetes in the subject. 
   
   
       3 . A method for differentiating between type 1 and type 2 diabetes in a subject, the method comprising the steps of:
 (a) obtaining a sample from the subject;   (b) determining the amount of adiponectin or leptin in the sample; and   (c) correlating the amount of adiponectin or leptin in the sample with the presence of either type 1 or type 2 diabetes in the subject.   
   
   
       4 . The method of  claim 3 , wherein the levels of both adiponectin and leptin in the sample are determined and extrapolated into a ratio of adiponectin:leptin and/or leptin:adiponectin, and the ratio is correlated with the presence of either type 1 or type 2 diabetes in the subject. 
   
   
       5 . A method for detection and diagnosis of type 1 diabetes, type 2 diabetes and/or diabetic disorder comprising:
 detecting at least one or more protein biomarkers in a subject sample, and; correlating the detection of one or more protein biomarkers with a diagnosis of type 1 diabetes, type 2 diabetes and/or diabetic disorder, wherein the correlation takes into account the detection of one or more biomarker in each diagnosis, as compared to normal subjects wherein the one or more protein markers are selected from:   adiponectin, leptin, ghrelin, resistin, autoantibodies to insulin, autoantibodies to glutamic acid decarboxylase, autoantibodies to IL-2, autoantibodies to IA-2, incretins, TNF-α, IL-6, and;   correlating the detection of one or more protein biomarkers with a diagnosis of type 1 diabetes, type 2 diabetes and/or diabetic disorder, wherein the correlation takes into account the detection of one or more protein biomarkers in each diagnosis, as compared to normal subjects.   
   
   
       6 . The method of  claim 5 , wherein one or more protein biomarkers are used to diagnose type 1 diabetes, type 2 diabetes and/or diabetic disorder. 
   
   
       7 . The method of  claim 5 , comprising:
 generating data on immobilized subject samples on a biochip array, by subjecting the biochip array to laser ionization and detecting intensity of signal for mass/charge ratio; and,   transforming the data into computer readable form;   and executing an algorithm that classifies the data according to user input parameters, for detecting signals that represent markers present in patients suffering from type 1 diabetes, type 2 diabetes and/or diabetic disorder and are lacking in formal subject controls.   
   
   
       8 . A method for detection and diagnosis of type 1 diabetes, type 2 diabetes and/or diabetic disorder comprising:
 detecting at least one or more protein biomarkers in a subject sample, and; correlating the detection of one or more protein biomarkers with a diagnosis of type 1 diabetes, type 2 diabetes and/or diabetic disorder, wherein the correlation takes into account the detection of one or more biomarker in each diagnosis, as compared to normal subjects wherein the one or more protein markers are selected from:   adiponectin, leptin, ghrelin, resistin, autoantibodies to insulin, autoantibodies to glutamic acid decarboxylase, autoantibodies to IL-2, autoantibodies to IA-2, incretins, TNF-α, and IL-6, fragments, or variants thereof, and;   correlating the detection of one or more protein biomarkers with a diagnosis of type 1 diabetes, type 2 diabetes and/or diabetic disorder, wherein the correlation takes into account the detection of one or more protein biomarkers in each diagnosis, as compared to normal subjects.   
   
   
       9 . The method  claim 8 , wherein one or more protein biomarkers are used to diagnose type 1 diabetes, type 2 diabetes and/or diabetic disorder. 
   
   
       10 . A kit for diagnosing type 1 diabetes, type 2 diabetes and/or diabetic disorder in a subject, the kit comprising:
 (a) a substrate for holding a biological sample isolated from a human subject suspected of having type 1 diabetes, type 2 diabetes and/or diabetic disorder,   (b) an agent that specifically binds at least one or more of the diabetic proteins; and,   (c) printed instructions for reacting the agent with the biological sample or a portion of the biological sample to detect the presence or amount of at least one marker in the biological sample.