Research on Potential Biomarkers of Prediabetes and Diabetes Based on MALDI-TOF MS Platform.

Study Overview
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Brief Summary
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Through the MALDI-TOF MS platform, explore the proteomics and peptidomics differences of fasting serum/plasma and urine between non pregnant people with normal glucose tolerance test and prediabetes /diabetes patients, pregnant people with normal glucose tolerance test and pregnant diabetes patients respectively; To explore the role of its proteomics and peptidomics differences in the diagnosis of prediabetes and diabetes, and to establish a new method of differential diagnosis by using the omics data and key characteristic peaks to find potential new diagnostic markers.

Detailed Description
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Prediabetes is a stage of abnormal glucose metabolism between normal blood glucose level and diabetes, which is a gray zone between normal and abnormal, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both. It is a very important high-risk group of diabetes. Diabetes is a group of metabolic diseases characterized by hyperglycemia caused by a variety of causes. Gestational diabetes mellitus refers to varying degrees of abnormal glucose metabolism that occur during pregnancy. This project aims to detect differential feature peaks through MALDI-TOF MS technology between non pregnant people with normal glucose tolerance test and prediabetes/diabetes patients, pregnant people with normal glucose tolerance test and pregnant diabetes patients respectively and to establish a clinical predictive diagnostic model based on differences, and to evaluate the model.

Official Title
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Research on Potential Biomarkers of Prediabetes and Diabetes Based on MALDI-TOF MS Platform.

Conditions
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Prediabetes, Diabetes Mellitus, Gestational Diabetes Mellitus, Proteomics

Intervention / Treatment
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* Diagnostic Test: Oral Glucose Tolerance Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for cases: Non pregnant people: the remaining fasting serum/plasma and urine samples of prediabetes/diabetes patients (prediabetes: IFG: FPG 6.1-6.9mmol/L, Blood glucose 2h after meal<7.8mmol/L（WHO）; IGT: FPG<7.0mmol/L, Blood glucose 2h after meal 7.8-11.1mmol/L（WHO）; diabetes: Typical symptoms of diabetes, FPG >= 7.0mmol/L or 75g OGTT 2h blood glucose >= 11.1mmol/L). Pregnant people: the remaining fasting serum/plasma and urine samples of gestational diabetes patients (75g OGTT test FPG >= 5.1mmol/L or 1h blood glucose >= 10.0mmol/L or 2h blood glucose >= 8.5mmol/L（IADPSG; ADA)). Inclusion criteria of the controls were as follows: Non pregnant people: the remaining fasting serum/plasma and urine samples of normal population for glucose tolerance test (FPG 3.9-6.1mmol/L,75g OGTT test 1h blood glucose 6.7-11.1mmol/L,75g OGTT test 2h blood glucose 3.6-7.8mmol/L). Pregnant people: the remaining fasting serum/plasma and urine samples of people who do not meet the diagnostic criteria for gestational diabetes (3.9<=75g OGTT test FPG<5.1mmol/L,6.7 <= 1h blood glucose<10.0mmol/L,3.6<=2h blood glucose<8.5mmol/L). - Exclusion Criteria: Common exclusion criteria for cases and control were as follows: The sample volume of serum/plasma/urine is less than 300ul; Improper storage of samples or repeated freezing and thawing; The serum /plasma has obvious hemolysis, lipemia or jaundice. -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non pregnant people with prediabetes or diabetes<br>Non pregnancy meeting the diagnosis of prediabetes or diabetes. | Diagnostic Test: Oral Glucose Tolerance Test<br>* Grouping based on detected oral glucose tolerance test results without any other intervention.<br>|
| Non pregnant people with normal glucose tolerance<br>Non pregnant population with normal Oral Glucose Tolerance Test results. | Diagnostic Test: Oral Glucose Tolerance Test<br>* Grouping based on detected oral glucose tolerance test results without any other intervention.<br>|
| pregnant people with gestational diabetes mellitus<br>Pregnant people who meet the diagnosis of gestational diabetes. | Diagnostic Test: Oral Glucose Tolerance Test<br>* Grouping based on detected oral glucose tolerance test results without any other intervention.<br>|
| pregnant people with normal glucose tolerance<br>Pregnant people with normal Oral Glucose Tolerance Test results. | Diagnostic Test: Oral Glucose Tolerance Test<br>* Grouping based on detected oral glucose tolerance test results without any other intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and types of proteins/peptides differential characteristic peaks | Obtain the number and types of proteins/peptides differential characteristic peaks between the case group and the control group through data analysis. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROC curve and area under curve AUC of clinical predictive diagnostic model | Construct a clinical predictive diagnostic model based on the obtained proteins/peptides differential feature peaks and calculate the area under the ROC curve AUC to evaluate the predictive effect of the model. | one year |