NCT05265741

Gestational Diabetes Mellitus (GDM) in Pregnant Women

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 65 (estimated)
• Sponsor: Long Island University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Gestational Diabetes Mellitus
• Pregnancy Complications

Timeline

• Start date: 2021-11-09
• Primary completion: 2024-02-10
• Completion: 2024-12-31
• First posted: 2022-03-03
• Last updated: 2023-04-13

Locations

1 site across 1 country: United States