Gut and Oral Microbiome of GDM Patients During Pregnancy

Completed

• Conditions: Pregnancy Related; Gestational Diabetes

• Registration Number: NCT04420507
• Lead Sponsor: Peking Union Medical College Hospital

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.

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 9\~14,24\~28 and 32\~37 gestational weeks separately. The investigators will also perform oral examination between 24\~28 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 Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2018-09-10
• Primary Completion: 2019-04-30
• Status Verified: 2020-03
• Study Completion: 2020-04-30
• Study First Submitted QC: 2020-06-05
• Last Update Submitted: 2020-06-05
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 163

Inclusion Criteria

• pregnant women
• gestational age: before 13+6 weeks
• regular prenatal care in PUMCH

Exclusion Criteria

• have medical history or current conditions： Gastrointestinal disorders, for example: Gastritis, gastric ulcer, inflammatory bowel disease; Hypertension; Diabetes; SLE or other severe CTD;
• pregnant, combine with malignancy diseases;
• pregnant, can't ensure regular prenatal check.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).
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).

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China