Methods for prediction and early detection of diabetes
AssigneesZora Biosciences Oy, Baker Heart and Diabetes Institute
InventorsKevin HUYNH, Dianna MAGLIANO, Jonathan SHAW, Mika HILVO, Reijo LAAKSONEN, Peter MEIKLE
Life of this patent
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Abstract
The present disclosure is related to the field of diabetes diagnostics. It introduces novel biomarkers that can be used to predict diabetes and detect presence of the disease. In addition, novel fatty acid biomarkers are presented.
Claims150
An in vitro method for assessing whether a subject is at risk to develop or is suffering from type 2 diabetes comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- (c) determining that the subject is suffering from or is at an increased risk of developing type 2 diabetes, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
An in vitro method for assessing whether a subject is at risk to develop or is suffering from type 2 diabetes comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- (c) determining that the subject is suffering from or is at an increased risk of developing type 2 diabetes, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D, when compared to a control.
An in vitro method for assessing whether a subject undergoing statin treatment is at risk to develop or is suffering from type 2 diabetes comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- and
- (c) determining that the subject is suffering from or is at an increased risk of developing type 2 diabetes, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
An in vitro method for assessing whether a subject undergoing statin treatment is at risk to develop or is suffering from type 2 diabetes comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- (c) determining that the subject is suffering from or is at an increased risk of developing type 2 diabetes, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D, when compared to a control.
An in vitro method of evaluating the effectiveness of a diabetes therapy in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- and
- (c) determining that the therapy is effective, if said sample contains a decreased combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
An in vitro method of evaluating the effectiveness of a diabetes therapy in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- (c) determining that the therapy is effective, if said sample contains a decreased combination biomarker value of the at least one diabetes biomarker from Group C and the at least one diabetes biomarker from Group D, when compared to a control.
An in vitro method for assessing whether a subject is at risk to develop type 2 diabetes, wherein the risk to develop type 2 diabetes is determined according to the following formula:
- r=intercept+a×Cer(d18:1/18:0)/Cer(d18:1/16:0)+b×BMI+c×glucose+d×HbA1c+e×age+f×LDL-cholesterol+g×HDL-cholesterol+h×triglycerides+i×systolic blood pressure+j×insulin+k×CRP+l×gender,
- wherein a, b, c, d, e, f, g, h, i, j, k and l are real numbers and logistic transformation (risk=(exp(r)/1+exp(r))*100) is optionally performed for the formula.
A method of detecting in a sample from a subject a concentration of at least one diabetes biomarker from Group A and a concentration of at least one diabetes biomarker from Group B comprising:
- (a) assaying the sample from said subject to determine the concentration of the at least one diabetes biomarker from Group A;
- (b) assaying the sample from said subject to determine the concentration of the at least one diabetes biomarker from Group B;
- and optionally
- (c) comparing a combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B to a control.
A method of detecting in a sample from a subject a concentration of at least one diabetes biomarker from Group C and a concentration of a diabetes biomarker from Group D comprising:
- (a) assaying the sample from said subject to determine the concentration of the at least one diabetes biomarker from Group C;
- (b) assaying the sample from said subject to determine the concentration of the at least one diabetes biomarker from Group D;
- and optionally
- (c) comparing a combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D to a control.
An in vitro method for assessing the progression of diabetes in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- (c) determining that diabetes has progressed, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
An in vitro method for assessing the progression of diabetes in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- (c) determining that diabetes has progressed, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D, when compared to a control.
An in vitro method for assessing whether a subject is at risk to develop or is suffering from diabetes complication(s) comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- (c) determining that the subject is suffering from or is at an increased risk of developing diabetes complication(s), if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
An in vitro method for assessing whether a subject is at risk to develop or is suffering from diabetes complication(s) comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- (c) determining that the subject is suffering from or is at an increased risk of developing diabetes complication(s), if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D, when compared to a control.
A method of collecting data for assessing whether a subject is at risk to develop or is suffering from type 2 diabetes comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- and
- (c) determining that the subject is suffering from or is at an increased risk of developing type 2 diabetes, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
A method of collecting data for assessing whether a subject is at risk to develop or is suffering from type 2 diabetes comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- and
- (c) determining that the subject is suffering from or is at an increased risk of developing type 2 diabetes, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D, when compared to a control.
A method of collecting data for assessing whether a subject undergoing statin treatment is at risk to develop or is suffering from type 2 diabetes comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- and
- (c) determining that the subject is suffering from or is at an increased risk of developing type 2 diabetes, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
A method of collecting data for assessing whether a subject undergoing statin treatment is at risk to develop or is suffering from type 2 diabetes comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- and
- (c) determining that the subject is suffering from or is at an increased risk of developing type 2 diabetes, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D, when compared to a control.
A method of collecting data for evaluating the effectiveness of a diabetes therapy in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- and
- (c) determining that the therapy is effective, if said sample contains a decreased combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
A method of collecting data for evaluating the effectiveness of a diabetes therapy in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- and
- (c) determining that the therapy is effective, if said sample contains a decreased combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D, when compared to a control.
A method of collecting data for assessing the progression of diabetes in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- (c) determining that diabetes has progressed, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
A method of collecting data for assessing the progression of diabetes in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- (c) determining that diabetes has progressed, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D, when compared to a control.
A method of collecting data for assessing whether a subject is at risk to develop or is suffering from diabetes complication(s) comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- (c) determining that the subject is suffering from or is at an increased risk of developing diabetes complication(s), if said sample contains an increased biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
A method of collecting data for assessing whether a subject is at risk to develop or is suffering from diabetes complication(s) comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- (c) determining that the subject is suffering from or is at an increased risk of developing diabetes complication(s), if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D, when compared to a control.
A method of collecting data for assessing whether a subject is at risk to develop type 2 diabetes, wherein the risk to develop type 2 diabetes is determined according to the following formula:
- r=intercept+a×Cer(d18:1/18:0)/Cer(d18:1/16:0)+b×BMI+c×glucose+d×HbA1c+e×age+f×LDL-cholesterol+g×HDL-cholesterol+h×triglycerides+i×systolic blood pressure+j×insulin+k×CRP+l×gender,
- wherein a, b, c, d, e, f, g, h, i, j, k and l are real numbers and logistic transformation (risk=(exp(r)/1+exp(r))*100) is optionally performed for the formula.
A composition or kit for predicting, diagnosing or detecting diabetes or for performing the methods or uses according to any one of the preceding claims, wherein the composition or kit comprises at least one diabetes biomarker from Group A and at least one diabetes biomarker from Group B.
A composition or kit for predicting, diagnosing or detecting diabetes or for performing the methods or uses according to any one of the preceding claims, wherein the composition or kit comprises at least one diabetes biomarker from Group C and a diabetes biomarker from Group D.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or medicament for assessing whether a subject is at risk to develop or is suffering from type 2 diabetes comprising:
- (a) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- and
- (c) determining that the subject is suffering from or is at an increased risk of developing type 2 diabetes, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or medicament for assessing whether a subject is at risk to develop or is suffering from type 2 diabetes comprising:
- (a) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) a reagent for assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- and
- (c) determining that the subject is suffering from or is at an increased risk of developing type 2 diabetes, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D, when compared to a control.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or medicament for assessing whether a subject undergoing statin treatment is at risk to develop or is suffering from type 2 diabetes comprising:
- (a) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- and
- (c) determining that the subject is suffering from or is at an increased risk of developing type 2 diabetes, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or medicament for assessing whether a subject undergoing statin treatment is at risk to develop or is suffering from type 2 diabetes comprising:
- (a) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) a reagent for assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- and
- (c) determining that the subject is suffering from or is at an increased risk of developing type 2 diabetes, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D, when compared to a control.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or medicament for evaluating the effectiveness of diabetes therapy in a subject comprising:
- (a) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- and
- (c) determining that the therapy is effective, if said sample contains a decreased combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or medicament for evaluating the effectiveness of diabetes therapy in a subject comprising:
- (a) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) a reagent for assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- and
- (c) determining that the therapy is effective, if said sample contains a decreased combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D, when compared to a control.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or medicament for assessing the progression of diabetes in a subject comprising:
- (a) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- (c) determining that diabetes has progressed, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or medicament for assessing the progression of diabetes in a subject comprising:
- (a) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) a reagent for assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- (c) determining that diabetes has progressed, if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D, when compared to a control.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or medicament for assessing whether a subject is at risk to develop or is suffering from diabetes complication(s) comprising:
- (a) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group A;
- (b) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group B;
- (c) determining that the subject is suffering from or is at an increased risk of developing diabetes complication(s), if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group A and the at least one diabetes biomarker from Group B, when compared to a control.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or medicament for assessing whether a subject is at risk to develop or is suffering from diabetes complication(s) comprising:
- (a) a reagent for assaying a sample from said subject to determine a concentration of at least one diabetes biomarker from Group C;
- (b) a reagent for assaying a sample from said subject to determine a concentration of a diabetes biomarker from Group D;
- (c) determining that the subject is suffering from or is at an increased risk of developing diabetes complication(s), if said sample contains an increased combination biomarker value of the at least one diabetes biomarker from Group C and the diabetes biomarker from Group D, when compared to a control.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or medicament for assessing whether a subject is at risk to develop type 2 diabetes, wherein the risk to develop type 2 diabetes is determined according to the following formula:
- r=intercept+a×Cer(d18:1/18:0)/Cer(d18:1/16:0)+b×BMI+c×glucose+d×HbA1c+e×age+f×LDL-cholesterol+g×HDL-cholesterol+h×triglycerides+i×systolic blood pressure+j×insulin+k×CRP+l×gender,
- wherein a, b, c, d, e, f, g, h, i, j, k and l are real numbers and logistic transformation (risk=(exp(r)/1+exp(r))*100) is optionally performed for the formula.
An in vitro method for assessing whether a subject is at risk to develop type 2 diabetes, wherein the risk to develop type 2 diabetes is determined according to the following formula:
- r=intercept+a×Cer(d18:1/18:0)/Cer(d18:1/16:0)+b×BMI+e×age,
- wherein a, b and e are real numbers and logistic transformation (risk=(exp(r)/1+exp(r))*100) is optionally performed for the formula.
An in vitro method for assessing whether a subject is at risk to develop type 2 diabetes, wherein the risk to develop type 2 diabetes is determined according to the following formula:
- r=intercept+a×Cer(d18:1/18:0)/Cer(d18:1/16:0)+b×BMI+c×glucose,
- wherein a, b and c are real numbers and logistic transformation (risk=(exp(r)/1+exp(r))*100) is optionally performed for the formula.
An in vitro method for assessing whether a subject is at risk to develop type 2 diabetes, wherein the risk to develop type 2 diabetes is determined according to the following formula:
- r=a×Cer(d18:1/18:0)/Cer(d18:1/16:0)+b×BMI,
- wherein a and b are real numbers and logistic transformation (risk=(exp(r)/1+exp(r))*100) is optionally performed for the formula.
An in vitro method for assessing whether a subject is at risk to develop type 2 diabetes, wherein the risk to develop type 2 diabetes is determined according to the following formula:
- r=a×Cer(d18:1/18:0)/Cer(d18:1/16:0)+c×glucose,
- wherein a and c are real numbers and logistic transformation (risk=(exp(r)/1+exp(r))*100) is optionally performed for the formula.
An in vitro method for assessing whether a subject is at risk to develop type 2 diabetes, wherein the risk to develop type 2 diabetes is determined according to the following formula:
- r=a×Cer(d18:1/18:0)/Cer(d18:1/16:0)+d×HbA1c,
- wherein a and d are real numbers and logistic transformation (risk=(exp(r)/1+exp(r))*100) is optionally performed for the formula
An in vitro method for assessing whether a subject is at risk to develop or is suffering from fatty liver disease comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group E;
- (b) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group F;
- (c) determining that the subject is suffering from or is at an increased risk of developing fatty liver disease, if said sample contains an increased combination biomarker value of the at least one fatty liver biomarker from Group E and the at least one fatty liver biomarker from Group F, when compared to a control.
An in vitro method of evaluating the effectiveness of a fatty liver disease therapy in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group E;
- (b) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group F;
- and
- (c) determining that the therapy is effective, if said sample contains a decreased combination biomarker value of the at least one fatty liver biomarker from Group E and the at least one fatty liver biomarker from Group F, when compared to a control.
A method of detecting in a sample from a subject a concentration of at least one fatty liver biomarker from Group E and a concentration of at least one fatty liver biomarker from Group F comprising:
- (a) assaying the sample from said subject to determine the concentration of the at least one fatty liver biomarker from Group E;
- (b) assaying the sample from said subject to determine the concentration of the at least one fatty liver biomarker from Group F;
- and optionally
- (c) comparing a combination biomarker value of the at least one fatty liver biomarker from Group E and the at least one fatty liver biomarker from Group F to a control.
An in vitro method for assessing the progression of fatty liver disease in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group E;
- (b) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group F;
- (c) determining that fatty liver disease has progressed, if said sample contains an increased combination biomarker value of the at least one fatty liver biomarker from Group E and the at least one fatty liver biomarker from Group F, when compared to a control.
A method of collecting data for assessing whether a subject is at risk to develop or is suffering from fatty liver disease comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group E;
- (b) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group F;
- and
- (c) determining that the subject is suffering from or is at an increased risk of developing fatty liver disease, if said sample contains an increased combination biomarker value of the at least one fatty liver biomarker from Group E and the at least one fatty liver biomarker from Group F, when compared to a control.
A method of collecting data for evaluating the effectiveness of a fatty liver disease therapy in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group E;
- (b) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group F;
- and
- (c) determining that the therapy is effective, if said sample contains a decreased combination biomarker value of the at least one fatty liver biomarker from Group E and the at least one fatty liver biomarker from Group F, when compared to a control.
A method of collecting data for assessing the progression of fatty liver disease in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group E;
- (b) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group F;
- (c) determining that fatty liver disease has progressed, if said sample contains an increased combination biomarker value of the at least one fatty liver biomarker from Group E and the at least one fatty liver biomarker from Group F, when compared to a control.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or reagent for assessing whether a subject is at risk to develop or is suffering from fatty liver disease comprising:
- (a) a reagent for assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group E;
- (b) a reagent for assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group F;
- and
- (c) determining that the subject is suffering from or is at an increased risk of developing fatty liver disease, if said sample contains an increased combination biomarker value of the at least one fatty liver biomarker from Group E and the at least one fatty liver biomarker from Group F, when compared to a control.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or reagent for evaluating the effectiveness of fatty liver disease therapy in a subject comprising:
- (a) a reagent for assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group E;
- (b) a reagent for assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group F;
- and
- (c) determining that the therapy is effective, if said sample contains a decreased combination biomarker value of the at least one fatty liver biomarker from Group E and the at least one fatty liver biomarker from Group F, when compared to a control.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or reagent for assessing the progression of fatty liver disease in a subject comprising:
- (a) a reagent for assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group E;
- (b) a reagent for assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group F;
- (c) determining that fatty liver disease has progressed, if said sample contains an increased combination biomarker value of the at least one fatty liver biomarker from Group E and the at least one fatty liver biomarker from Group F, when compared to a control.
A use of one or more reagent(s) in the manufacture of a kit, composition, preparation or reagent for detecting in a sample from a subject a concentration of at least one fatty liver biomarker from Group E and a concentration of at least one fatty liver biomarker from Group F comprising:
- (a) a reagent for assaying the sample from said subject to determine the concentration of the at least one fatty liver biomarker from Group E;
- (b) a reagent for assaying the sample from said subject to determine the concentration of the at least one fatty liver biomarker from Group F;
- and optionally
- (c) comparing a combination biomarker value of the at least one fatty liver biomarker from Group E and the at least one fatty liver biomarker from Group F to a control.
An in vitro method for assessing whether a subject is at risk to develop or is suffering from fatty liver disease comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group A;
- (b) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group B;
- (c) determining that the subject is suffering from or is at an increased risk of developing fatty liver disease, if said sample contains an increased combination biomarker value of the at least one fatty liver biomarker from Group A and the at least one fatty liver biomarker from Group B, when compared to a control.
An in vitro method for assessing whether a subject is at risk to develop or is suffering from fatty liver disease comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group C;
- (b) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group D;
- (c) determining that the subject is suffering from or is at an increased risk of developing fatty liver disease, if said sample contains an increased combination biomarker value of the at least one fatty liver biomarker from Group C and the at least one fatty liver biomarker from Group D, when compared to a control.
An in vitro method of evaluating the effectiveness of a fatty liver disease therapy in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group A;
- (b) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group B;
- and
- (c) determining that the therapy is effective, if said sample contains a decreased combination biomarker value of the at least one fatty liver biomarker from Group A and the at least one fatty liver biomarker from Group B, when compared to a control.
An in vitro method of evaluating the effectiveness of a fatty liver disease therapy in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group C;
- (b) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group D;
- and
- (c) determining that the therapy is effective, if said sample contains a decreased combination biomarker value of the at least one fatty liver biomarker from Group C and the at least one fatty liver biomarker from Group D, when compared to a control.
A method of detecting in a sample from a subject a concentration of at least one fatty liver biomarker from Group A and a concentration of at least one fatty liver biomarker from Group B comprising:
- (a) assaying the sample from said subject to determine the concentration of the at least one fatty liver biomarker from Group A;
- (b) assaying the sample from said subject to determine the concentration of the at least one fatty liver biomarker from Group B;
- and optionally
- (c) comparing a combination biomarker value of the at least one fatty liver biomarker from Group A and the at least one fatty liver biomarker from Group B to a control.
A method of detecting in a sample from a subject a concentration of at least one fatty liver biomarker from Group C and a concentration of at least one fatty liver biomarker from Group D comprising:
- (a) assaying the sample from said subject to determine the concentration of the at least one fatty liver biomarker from Group C;
- (b) assaying the sample from said subject to determine the concentration of the at least one fatty liver biomarker from Group D;
- and optionally
- (c) comparing a combination biomarker value of the at least one fatty liver biomarker from Group C and the at least one fatty liver biomarker from Group D to a control.
An in vitro method for assessing the progression of fatty liver disease in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group A;
- (b) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group B;
- (c) determining that fatty liver disease has progressed, if said sample contains an increased combination biomarker value of the at least one fatty liver biomarker from Group A and the at least one fatty liver biomarker from Group B, when compared to a control.
An in vitro method for assessing the progression of fatty liver disease in a subject comprising:
- (a) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group C;
- (b) assaying a sample from said subject to determine a concentration of at least one fatty liver biomarker from Group D;
- (c) determining that fatty liver disease has progressed, if said sample contains an increased combination biomarker value of the at least one fatty liver biomarker from Group C and the at least one fatty liver biomarker from Group D, when compared to a control.
The method of any one of the preceding claims, wherein the fatty liver biomarker is selected from any one of Group A, Group B, Group C, Group D, Group E and Group F biomarkers.
The method of any one of the preceding claims, wherein the progression of the subject's condition from a healthy condition to a fatty liver phase, to NASH and/or to fibrosis, cirrhosis, liver failure and/or liver cancer is assessed.
The method of any one of the preceding claims, wherein the progression from a fatty liver stage or NASH to fibrosis, cirrhosis, liver failure and/or liver cancer is assessed.
The method of any one of the preceding claims, wherein the severity of fatty liver disease is assessed.
The method of any one of the preceding claims, wherein the progression of the subject's condition from a healthy condition to NAFLD is assessed.
The method of any one of the preceding claims, wherein the progression from NAFLD to NASH is assessed.
The method of any one of the preceding claims, wherein the progression from NAFLD to severe fatty liver stages is assessed.
The method of any one of the preceding claims, wherein the progression from NAFLD to fibrosis, cirrhosis, liver failure and/or liver cancer is assessed.
The method of any one of the preceding claims, wherein the progress of fatty liver disease is monitored to assess if an administered treatment has affected to the progress of the disease.
The method of any one of the preceding claims, wherein the combination of the concentrations of the at least one fatty liver biomarker from Group E and the at least one fatty liver biomarker from Group F is (are) selected from Table 7.
The method of any one of the preceding claims, wherein the at least one fatty liver biomarker from Group F is LPC(MHDA) [sn1] and/or LPC(MHDA) [sn2].
The method of any one of the preceding claims, wherein determining that the subject is suffering from or is at an increased risk of developing diabetes and/or fatty liver disease is determined by one assay.
The method of any one of the preceding claims, wherein the same biomarkers are used for predicting and diagnosing diabetes and fatty liver.
The method of any one of the preceding claims, wherein the same biomarker combinations are used for predicting and diagnosing diabetes and fatty liver.
The method of any one of the preceding claims, wherein the diabetes and fatty liver biomarkers are selected from Table 6 or Table 7.
An in vitro method for assessing whether a subject is at risk to develop type 2 diabetes, wherein the risk to develop type 2 diabetes is determined according to the following formula:
- r=a×Cer(d18:1/18:0)/Cer(d18:1/16:0)+b×BMI,
- wherein a and b are real numbers and transformation to logistic (risk=(exp(r)/1+exp(r))*100) or time-to-event model is optionally performed for the formula.
An in vitro method for assessing whether a subject is at risk to develop type 2 diabetes, wherein the risk to develop type 2 diabetes is determined according to the following formula:
- r=intercept+a×Cer(d18:1/18:0)/Cer(d18:1/16:0)+b×BMI+e×age,
- wherein a, b and e are real numbers and transformation to logistic (risk=(exp(r)/1+exp(r))*100) or time-to-event model is optionally performed for the formula.
An in vitro method for assessing whether a subject is at risk to develop type 2 diabetes, wherein the risk to develop type 2 diabetes is determined according to the following formula:
- r=a×Cer(d18:1/18:0)/Cer(d18:1/16:0),
- wherein a is a real number and transformation to logistic (risk=(exp(r)/1+exp(r))*100) or time-to-event model is optionally performed for the formula.
Dependencies are inferred from the claim text.