Gestational Diabetes Mellitus (GDM) in Pregnant Women

Last updated: April 11, 2023
Sponsor: Long Island University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Diabetes And Hypertension

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT05265741
Mamome-GDM-05
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 firsttrimester Subgroups A2 and B2 are pregnant women in their second trimester Subgroups A3 andB3 are pregnant women in their third trimester

Exclusion

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 samplecollection (The participant will be informed of the collection procedure by the recruiterand will be made aware of this requirement, we will also confirm when the first sample istaken through a phone call if for any reason the participant still made a mistake, will askher to collect another sample to replace it) Development of any serious pregnancycomplication during the participation period (e.g preeclampsia, preterm birth, miscarriage,etc) Excessive vomiting, diarrhea, or gastrointestinal symptoms for more than 5 consecutivedays during the participation period. This will be confirmed through a weekly check-up callby the on-site recruiter or by Dr.Yin if the patient seeks treatment

Study Design

Total Participants: 65
Study Start date:
November 09, 2021
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Long Island University

    New York, New York 11201
    United States

    Active - Recruiting

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