Study on Serum Metabolomics of GDM
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| GDM group Pregnant women aged 20-40 with positive oral glucose tolerance test (OGTT) results at 24-28 weeks. |
Other: Specimen samples and baseline data collection
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.
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| non-GDM group Pregnant women aged 20-40 with negative OGTT results at 24-28 weeks. |
Other: Specimen samples and baseline data collection
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.
|
| Control group Healthy non-pregnant women aged 20-40. |
Other: Specimen samples and baseline data collection
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.
|
Outcome Measures
Primary Outcome Measures
- Content of serum metabolomics [Second trimester (24-28 gestational weeks)]
Use high-resolution mass spectrometry to identify serum metabolites and then quantitatively detect the content of these metabolites to find differential metabolites with predictive ability for diseases.
Eligibility Criteria
Criteria
Inclusion Criteria:
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No obvious abnormalities in all inspection items
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No history of diabetes
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No particular dietary habits
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No previous history of other mental illnesses
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No history of drug abuse or allergies
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No history of smoking or drinking
Exclusion Criteria:
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Pregnancy complications such as uterine fibroids, hyperthyroidism/hypothyroidism, and antiphospholipid antibody syndrome
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Critical illnesses such as cardiovascular disease or abnormal liver/kidney function
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Personal history of syphilis, HIV positive, and other infectious diseases
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Artificial insemination or IVF pregnancy
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Multiple pregnancy (twins or more)
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Patients participating in other clinical studies
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Other reasons that researchers think are inappropriate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Women's Hospital School Of Medicine Zhejiang University | Hangzhou | Zhejiang | China | 310006 |
Sponsors and Collaborators
- Zhejiang University
- Women's Hospital School Of Medicine Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-20230193-R