Study on Serum Metabolomics of GDM

Study Overview
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Brief Summary
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This study aims to collect serum samples from healthy non-pregnant women, pregnant women with and without Gestational Diabetes Mellitus (GDM). We will analyze the metabolite changes among the three groups using clinical metabolomics and identify potential biomarkers and metabolic pathways. This study will provide scientific evidence for early clinical diagnosis, prevention, control, and treatment research of GDM.

Official Title
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Serum Metabolomics Analysis for Early Diagnosis and Pathogenesis of Gestational Diabetes Mellitus

Conditions
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GDM, Pathogenesis, Diagnosis

Intervention / Treatment
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* Other: Specimen samples and baseline data collection
* Other: Specimen samples and baseline data collection
* Other: Specimen samples and baseline data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No obvious abnormalities in all inspection items No history of diabetes No particular dietary habits No previous history of other mental illnesses No history of drug abuse or allergies No history of smoking or drinking Exclusion Criteria: Pregnancy complications such as uterine fibroids, hyperthyroidism/hypothyroidism, and antiphospholipid antibody syndrome Critical illnesses such as cardiovascular disease or abnormal liver/kidney function Personal history of syphilis, HIV positive, and other infectious diseases Artificial insemination or IVF pregnancy Multiple pregnancy (twins or more) Patients participating in other clinical studies Other reasons that researchers think are inappropriate

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| GDM group<br>Pregnant women aged 20-40 with positive oral glucose tolerance test (OGTT) results at 24-28 weeks. | Other: Specimen samples and baseline data collection<br>* The remaining serum samples from routine blood tests of subjects will be collected (without additional blood collection), with a serum sample size of approximately 1 mL per subject. The samples will be pre-processed and stored at ultra-low temperatures. At the same time, clinical baseline data of subjects will be collected from outpatient or inpatient medical records, including but not limited to age, height, weight, blood pressure, and gestational age.<br>|
| non-GDM group<br>Pregnant women aged 20-40 with negative OGTT results at 24-28 weeks. | Other: Specimen samples and baseline data collection<br>* The remaining serum samples from routine blood tests of subjects will be collected (without additional blood collection), with a serum sample size of approximately 1 mL per subject. The samples will be pre-processed and stored at ultra-low temperatures. At the same time, clinical baseline data of subjects will be collected from outpatient or inpatient medical records, including but not limited to age, height, weight, blood pressure, and gestational age.<br>|
| Control group<br>Healthy non-pregnant women aged 20-40. | Other: Specimen samples and baseline data collection<br>* The remaining serum samples from routine blood tests of subjects will be collected (without additional blood collection), with a serum sample size of approximately 1 mL per subject. The samples will be pre-processed and stored at ultra-low temperatures. At the same time, clinical baseline data of subjects will be collected from outpatient or inpatient medical records, including but not limited to age, height, weight, blood pressure, and gestational age.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Content of serum metabolomics | Based on non-targeted metabolomics technology, the metabolites in serum were comprehensively detected. Differential metabolites were screened using multivariate statistical analysis. Then quantitatively detect the content of these metabolites to find the differential metabolites with predictive ability for GDM. | Second trimester (24-28 gestational weeks) | 

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