CN-120703380-B - Gestational diabetes diagnosis marker combination and application thereof, kit, device and assessment model

Abstract

The invention belongs to the field of marker detection, and particularly relates to a gestational diabetes diagnosis marker combination and application, a kit, a device and an evaluation model thereof. It is an object of the present invention to provide the use of a detection marker comprising fructosyl glycine and/or lysophosphatidylethanolamine LysoPE (20:5 (5Z, 8Z,11Z,14Z, 17Z)/0:0) in the prediction of gestational diabetes. Applications include detecting gestational diabetes or related diseases, predicting the risk of developing gestational diabetes or related diseases, or predicting the prognostic effect of developing gestational diabetes or related diseases. The diagnosis marker constructed by the invention is beneficial to identifying high-risk GDM populations in clinic and provides important clinical early warning for preventing and treating gestational diabetes patients.

Inventors

• CHEN CHANG
• Yuan Rongfei
• ZHANG FENGJING
• LIU JIALE
• ZHANG HUA

Assignees

• 重庆医科大学

Dates

Publication Date

20260512

Application Date

20250609

Claims (4)

1. 1. Use of a gestational diabetes diagnostic marker in combination with the preparation of a reagent for detecting gestational diabetes, characterized in that the gestational diabetes diagnostic marker comprises fructosyl glycine and lysophosphatidylethanolamine LysoPE (20:5 (5 z,8z,11z,14z,17 z)/0:0).
2. 2. The use according to claim 1, wherein the diagnostic marker of gestational diabetes is derived from one or more of plasma, serum, whole blood.
3. 3. A gestational diabetes diagnosis apparatus, comprising: An information acquisition module for obtaining an abundance of diagnostic markers of a subject sample, wherein the diagnostic markers comprise fructosyl glycine and lysophosphatidylethanolamine LysoPE (20:5 (5 z,8z,11z,14z,17 z)/0:0); and an information processing module for providing a prognosis of gestational diabetes based on the abundance of the diagnostic marker.
4. 4. A gestational diabetes diagnosis apparatus according to claim 3, wherein when present The signal intensity of the fructosyl glycine, namely the area under the curve of the liquid chromatography-mass spectrum signal is higher than 5600; LysoPE (20:5 (5Z, 8Z,11Z,14Z, 17Z)/0:0), i.e., area under the curve of the liquid chromatography-mass spectrometry signal, is higher than 54000, and/or When the calculated value based on the combined predictive factor is higher than 350000, the information processing module gives an evaluation result of predicting that the risk of the gestational diabetes mellitus is high, wherein, The calculation formula is as follows: Calculated value of joint predictor = signal intensity of fructosyl glycine 2.708 Signal strength of + LysoPE (20:5 (5Z, 8Z,11Z,14Z, 17Z)/0:0) 6.059-9.088。

Description

Gestational diabetes diagnosis marker combination and application thereof, kit, device and assessment model Technical Field The invention belongs to the field of marker detection, and particularly relates to a gestational diabetes diagnosis marker combination and application, a kit, a device and an evaluation model thereof. Background Gestational diabetes mellitus (gestational diabetes mellitus, GDM) refers to a pathological state of abnormal glucose metabolism that first occurs or is found during pregnancy, and is diagnosed with fasting and/or postprandial blood glucose levels exceeding a gestational threshold. As the pregnancy complication with highest global morbidity, the GDM morbidity reaches 14%, is closely related to perinatal risks such as fetal growth limitation, megaly, premature birth and the like, and can also increase the distant metabolism abnormality of offspring and the incidence risk of puerperal type 2 diabetes (T2 DM) and cardiovascular diseases, thereby forming a great public health challenge. Epidemiological studies have shown that with changes in dietary structure, lifestyle statics and rising proportion of advanced gestations, the incidence of GDM has increased significantly in the last decade, further exacerbating the burden on medical systems. At the clinical practice level, the oral glucose tolerance test (oral glucose tolerance test, OGTT) remains a central basis for current GDM screening and diagnosis. The test requires that the pregnant woman takes 75g of glucose solution within 5 minutes after being strictly fasted for 8-12 hours, and three times of intravenous blood sampling are respectively carried out on a fasting state, 1 hour and 2 hours after taking sugar. Although the standardized flow ensures the detection accuracy, the defects of hunger stress, gastrointestinal reaction, multiple blood sampling and the like existing in the operation process obviously reduce the compliance of pregnant women. It is noted that, although the measurement of glycosylated hemoglobin (HbA 1 c) widely used by non-pregnant women can reflect blood glucose levels of approximately 3 months through a single random blood sampling, the measurement value is systematically low due to the change of the metabolic dynamics of pregnant erythrocytes and the blood dilution effect, so that the measurement value cannot meet the clinical requirement of GDM screening. This technical bottleneck highlights the need to develop new biomarkers, especially requiring the establishment of accurate detection systems based on a single random blood sample to achieve early risk prediction. Furthermore, since the inventors herein have studied numerous documents and patents, on the one hand, and have not set forth in detail all the details and content of the invention for the purpose of understanding the differences to those skilled in the art, on the other hand, the invention is by no means lacking in the features of the prior art, but rather the invention has all the features of the prior art, and the applicant retains the right of the prior art in the background of this invention. Disclosure of Invention Based on the technical problems, the invention provides a gestational diabetes diagnosis marker combination and application thereof, a kit, a device and an evaluation model, and belongs to the field of marker detection. It is an object of the present invention to provide a gestational diabetes diagnostic marker combination comprising fructosyl glycine and/or lysophosphatidylethanolamine LysoPE (20:5 (5Z, 8Z,11Z,14Z, 17Z)/0:0). It is also an object of the present invention to provide the use of a gestational diabetes diagnostic marker combination comprising fructosyl glycine and/or lysophosphatidylethanolamine LysoPE (20:5 (5Z, 8Z,11Z,14Z, 17Z)/0:0) in the prediction of gestational diabetes. According to a preferred embodiment, the application comprises: Detecting gestational diabetes or related diseases; Predicting the risk of developing gestational diabetes or related diseases, or Predicting the prognostic effect of gestational diabetes or related diseases. According to a preferred embodiment, the diagnostic marker for gestational diabetes is derived from one or more of plasma, serum, whole blood. It is also an object of the present invention to provide an assessment model for predicting gestational diabetes mellitus, which uses fructosyl glycine and/or lysophosphatidylethanolamine LysoPE (20:5 (5Z, 8Z,11Z,14Z, 17Z)/0:0) abundance as input variables for predicting gestational diabetes mellitus risk. According to a preferred embodiment, a high risk of gestational diabetes is predicted when the signal intensity of fructoglycine, i.e. the area under the curve of the liquid chromatography-mass spectrometry signal, is higher than 5600, the signal intensity of lysope (20:5 (5 z,8z,11z,14z,17 z)/0:0), i.e. the area under the curve of the liquid chromatography-mass spectrometry signal, is higher than 54000, and/or the calculated v