Gestational Diabetes Mellitus (GDM) in Pregnant Women

Study Overview
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Brief Summary
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The purpose of the trial is to discover and predict the development of GDM of pregnant women in their first trimester.

Detailed Description
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Gestational Diabetes Mellitus (GDM) is a type of diabetes that affects pregnant women and often develops in the middle and later stages of pregnancy. GDM can lead to adverse maternal outcomes such as preeclampsia, and postpartum hemorrhage, and undesirable infant outcomes such as macrosomia and neonatal hypoglycemia. GDM also increases the risk of long-term consequences such as the development of type 2 diabetes in mothers, metabolic syndrome, and cardiovascular diseases. Gut microbiota has been shown to play a significant role in the etiology of metabolic illnesses, and recent studies have demonstrated that the gut microbiota of GDM women is altered compared to those of healthy women. This trial aims to identify biomarkers during the first trimester (week 8-week 12) that can predict the likelihood of developing GDM while also examining potential links between GDM and gut microbiota. To achieve these objectives, the investigators have designed a trial that involves the collection of fecal samples from pregnant women for microbiome analysis at different stages of pregnancy. Although GDM is diagnosed at or after 24 weeks, the investigators will collect samples at the first, second, and third trimesters to determine if any alterations in the microbiome occur prior to symptom onset.

Official Title
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A Single Site, Observational, Administered to Pregnant Women at High Risk for Gestational Diabetes Mellitus

Conditions
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Gestational Diabetes Mellitus, Pregnancy Complications

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between the age of 18-45 Groups A and B have to be confirmed pregnant by blood test (confirmed by medical records) Subgroups A1 and B1 are pregnant women in their first trimester Subgroups A2 and B2 are pregnant women in their second trimester Subgroups A3 and B3 are pregnant women in their third trimester Exclusion Criteria: History of smoking or drinking during the pregnancy History of chronic diseases (cardiac, kidney, diabetes, hypertension, IBD,etc). Laxative use within 2 days prior to sample collection (The participant will be informed of the collection procedure by the recruiter and will be made aware of this requirement, we will also confirm when the first sample is taken through a phone call if for any reason the participant still made a mistake, will ask her to collect another sample to replace it) Development of any serious pregnancy complication during the participation period (e.g preeclampsia, preterm birth, miscarriage, etc) Excessive vomiting, diarrhea, or gastrointestinal symptoms for more than 5 consecutive days during the participation period. This will be confirmed through a weekly check-up call by the on-site recruiter or by Dr.Yin if the patient seeks treatment

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

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 |
| --- | --- |
| ArmA_Pregnant No Gestational Diabetes Mellitus<br>This group is composed of pregnant women divided into 3 subgroups, one of each trimester. This arm will be required to provide 2 fecal samples. One at the start of recruitment, and one at the end of a 4-week period of the trimester. | |
| ArmB_Pregnant with Gestational Diabetes Mellitus<br>This group is composed of pregnant women divided into 3 subgroups, one of each trimester. This arm will be required to provide 2 fecal samples. One at the start of recruitment, and one at the end of a 4-week period of the trimester. | |
| ArmC_Non- Pregnant Control<br>This group is composed of non-pregnant women. This arm will be required to provide 1 or more fecal samples. It will be used as a baseline for comparison of the microbiome | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Gestational Diabetes Mellitus (GDM) Week 8 to post-delivery throughout their entire pregnancy |  | Up to approximately GA Week 37 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Clinical Outcome (GCO) Rank Score (GCO Rank) |  | Up to approximately GA Week 37; up to approximately 12 weeks post birth | 
| Number of Participants With OGTT Oral Glucose Intolerance Test |  | Up to approximately GA Week 37 | 
| Number of Participants With live Birth |  | Up to approximately GA Week 37 | 
| Number of Participants With Preterm Birth |  | Up to approximately GA Week 37 | 
| Number of Participants at GA Week 24 Without an OGTT |  | GA Week 24-28 | 
| Gestational age at First GDM |  | Up to approximately GA Week 37 | 
| Gestational age at First Preeclampsia |  | Up to approximately GA Week 37 | 
| Gestational age at Delivery |  | Up to approximately GA Week 37 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational Diabetes Mellitus