Procedure of predicting type 2 diabetes development through analysis of N-glycans attached to the plasma proteins of a healthy person

A procedure for predicting type 2 diabetes development through quantitative analysis of N-glycans attached to the human plasma proteins, where said quantitative analysis comprises:

• (i) collection of a blood sample from a healthy person;
• (ii) isolation of plasma from the blood sample;
• (iii) release of the total plasma N-glycans by enzymatic hydrolysis using N-glycosidase;
• (iv) optionally, derivatization of the N-glycan mixture, using a reagent suitable to increase the detection sensitivity of such labeled N-glycans;
• (v) purification of the N-glycan mixture or labeled N-glycan mixture;
• (vi) separation and quantification of N-glycans or labeled N-glycans using a quantitative analytical technique;
• and
• (vii) obtained quantitative percentages of all N-glycans determined in step (vi) are used as input variables of a model:
• F(GP1,GP2, . . . ,GPX;D,S)
• where X, D and S are parameters of the model F with following meaning:
• X=total number of analyzed N-glycans from GP1 to GPX;
• D=age of the investigated person;
• S=sex of the investigated person;
• male=1, female=0;
• where the model constants are obtained by statistical data processing from analyzed population;
• and
• (viii) where the result F obtained in step (vii) for the investigated person is compared with a threshold T, which is statistically determined on the same population and which defines increased risk for type 2 diabetes (T2D) development in the future.