Identification of Gestational Diabetes Mellitus Related Urinary Biomarkers Along Pregnancy (From Early Pregnancy to Postpartum) by Using Proteomics and Metabolomics Analysis

Study Overview
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Brief Summary
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Gestational diabetes mellitus (GDM) has many adverse effects on pregnant women and fetuses. At present, no prediction marker for GDM in early pregnancy is accepted. There is still a lack of recognized early predictors. This study was designed to identity valuable biomarkers for GDM.This was a prospective observed cohort study. 140 pregnant women were recruited in early pregnancy, and followed up to 6 weeks postpartum. Glucose challenge test and 75g oral glucose tolerance test were performed after 24 weeks of pregnancy, and GDM was diagnosed according to the latest ADA standard. Urinary samples were collected in the first (<12 weeks), second (24 28 weeks) and third (32 weeks) trimester of pregnancy. Urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry. 15 cases of GDM women and 50 cases of control women were used for longitudinal analysis; 15 cases of GDM women and 15 cases of age matched control women were used for difference analysis.

Official Title
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Identification of Gestational Diabetes Mellitus Related Urinary Biomarkers Along Pregnancy (From Early Pregnancy to Postpartum) by Using Proteomics and Metabolomics Analysis

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Other: lifestyle intervention or insulin treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Pregnant women （<12 weeks） Exclusion Criteria: with renal dysfunction urine routine examination abnormalities for twice history of urinary and reproductive system diseases with other chronic diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gestational diabetes mellitus<br>Those women were diagnosed as gestational diabetes mellitus | Other: lifestyle intervention or insulin treatment<br>* Firstly，the gestational diabetes mellitus（GDM） women were treated with lifestyle intervention.Those women were treated with insulin if their blood glucose was not well Controled.<br>|
| Control<br>Those women were diagnosed without gestational diabetes mellitus | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary samples were analyzed | Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry. | in the first (<12 weeks) trimester of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary samples were analyzed | Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry. | in the second (24-28 weeks) trimester of pregnancy | 
| Urinary samples were analyzed | Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry. | in the third (>32 weeks) trimester of pregnancy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proteomics, Metabolomics