Methods for detecting gestational diabetes mellitus

A method for diagnosing gestational diabetes mellitus (GDM) in a pregnant female, said method comprising detecting citrullinated histone H3 in neutrophils isolated from said female, wherein the level of citrullinated histone H3 in the neutrophils is indicative whether the female is suffering from or whether the female is at risk for developing GDM.

A method for diagnosing gestational diabetes mellitus (GDM) in a pregnant female, said method comprising detecting at least one biomarker selected from the group consisting of cell-free DNA, cell-free nucleosomes, myeloperoxidase and alpha-1 antitrypsin in a serum or plasma sample isolated from said female, wherein the level of at least one of said biomarker in the serum or plasma sample is indicative whether the female is suffering from or whether the female is at risk for developing GDM.

A method for diagnosing gestational diabetes mellitus (GDM) in a pregnant female, said method comprising detecting the level of polymorphonuclear neutrophils (PMN) and peripheral blood mononuclear cells (PBMC) in a blood sample isolated from said female, wherein the ratio of PMN to PBMC in the blood sample is indicative whether the female is suffering from or whether the female is at risk for developing GDM.

A method for predicting or monitoring the efficacy of a therapeutic agent for use in treating GDM in a pregnant female, said method comprising detecting the level of at least one biomarker selected from the group consisting of cell-free DNA, cell-free nucleosomes, myeloperoxidase and alpha-1 antitrypsin in a serum or plasma sample isolated from a female pre and post treatment with said therapeutic agent, wherein a change in the level of at least one of said biomarker indicates efficacy of said agent.

A method for differentiating gestational diabetes mellitus (GDM) from auto-immune type I diabetes (T1DM) and/or from non-auto-immune type II diabetes (T2DM) in a pregnant female, said method comprising detecting at least one biomarker selected from the group consisting of cell-free DNA, cell-free nucleosomes, myeloperoxidase, neutrophil elastase, alpha-1 antitrypsin and DNaseI in a serum or plasma sample isolated from said female, wherein the level of at least one of said biomarker in the serum or plasma sample is indicative whether the female is suffering from or whether the female is at risk for developing GDM and/or whether the female is suffering from auto-immune type I diabetes (T1DM) or from non-auto-immune type II diabetes (T2DM).

A method for predicting the risk for developing a disorder selected from the group consisting of preeclampsia, thrombotic events and cardiovascular damage in a pregnant female said method comprising detecting NETosis in a serum or plasma sample isolated from said female, wherein the level of NETosis in the serum or plasma sample is indicative whether said female is at risk for developing preeclampsia, thrombotic events or cardiovascular damage.

A method for the selection of a therapeutic agent for use in treating GDM in a pregnant female, comprising detecting NETosis in a serum or plasma sample isolated from said female, wherein the level of NETosis in the serum or plasma sample is indicative whether circulatory polymorphic neutrophils (PMN) are used as target for the therapeutic agent.

A composition comprising one or more reagents which bind specifically with and/or detects cell-free DNA, cell-free nucleosomes, myeloperoxidase or alpha-1 antitrypsin in a serum or plasma sample isolated from a female for use in diagnosing, predicting, and/or monitoring of GDM and/or for selecting a therapeutic agent for use in treating GDM.

A composition comprising one or more reagents which bind specifically with and/or detects citrullinated histone H3 in neutrophils isolated from a female for use in diagnosing, predicting, and/or monitoring of GDM and/or for selecting a therapeutic agent for use in treating GDM.

Use of cell-free DNA, cell-free nucleosomes, myeloperoxidase, alpha-1 antitrypsin and/or citrullinated histone H3, in diagnosing, predicting, and/or monitoring of GDM and/or in selecting a therapeutic agent for use in treating GDM in a female.