Gut and Oral Microbiome of GDM Patients During Pregnancy
Study Details
Study Description
Brief Summary
The study aimed to clarify the characteristics of the intestinal and oral microbiome of Gestational Diabetes Mellitus(GDM) patients during the whole pregnancy, try to clarify the relationship between the microbiome and GDM.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The aims of the study are to reveal the possibly natural change of the gut and oral microbiome of GDM patients during pregnancy, and to explorer whether GDM happened during pregnancy are associated with the maternal gut and oral microbiomes. As a perspective cohort study, the researchers will recruit pregnant women in early pregnancy（before 13 gestational weeks）and following the pregnancies till delivery. The stool samples and saliva samples of the recruits will be collected in 914,2428 and 3237 gestational weeks separately. The investigators will also perform oral examination between 2428 weeks and sample subgingival plaque for test. Overall, all samples will be examined use 16S rRNA gene sequencing to analyze microbiome. And part of the samples of GDM patients will be analyzed using metagenomics. Combine with the pregnancy outcomes, the differences of gut and oral microbiome between GDM patients and healthy women will be expected, as well as the natural change during pregnancy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| GDM group pregnant women who are diagnosed after 75g OGTT test between 24~27+6 gestational weeks |
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| health group pregnant women who pass the 75g OGTT test and aren't diagnosed as GDM, and also don't have any other conditions, like hypertensive disorders, IBD, gastrointestinal ulcer, and so on. |
Outcome Measures
Primary Outcome Measures
- the gut and oral microbiome of GDM patients during pregnancy [the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)]
The composition and species of gut and oral microbiome of GDM patients,separately in the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks).
- the gut and oral microbiome of healthy pregnant women [the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)]
The composition and species of gut and oral microbiome of healthy pregnant women ,separately in the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks).
Secondary Outcome Measures
- The glucose level during pregnancy [the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)]
The fasting blood glucose level and the glycosylated albumin level in the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks). And the result of 75gOGTT test.
Eligibility Criteria
Criteria
Inclusion Criteria:
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pregnant women
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gestational age: before 13+6 weeks
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regular prenatal care in PUMCH
Exclusion Criteria:
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have medical history or current conditions： Gastrointestinal disorders, for example: Gastritis, gastric ulcer, inflammatory bowel disease; Hypertension; Diabetes; SLE or other severe CTD;
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pregnant, combine with malignancy diseases;
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pregnant, can't ensure regular prenatal check.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
- Chinese Academy of Medical Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Gut and oral microbiome of GDM