Gestational Diabetes Mellitus (GDM) in Pregnant Women

Pregnancy Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05265741
• Other study ID #: Mamome-GDM-05
• Status: Recruiting
• Start date: November 9, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Long Island University
• Contact: Nini Fan, MS,MBA
• Phone: 6469458999
• Email: nini.fan[@]mamome.io
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 31, 2024
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Pregnancy Complications

Locations

Country	Name	City	State
United States	Long Island University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Long Island University	BROOKLYN INNOSEQ INC.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hasan S, Aho V, Pereira P, Paulin L, Koivusalo SB, Auvinen P, Eriksson JG. Gut microbiome in gestational diabetes: a cross-sectional study of mothers and offspring 5 years postpartum. Acta Obstet Gynecol Scand. 2018 Jan;97(1):38-46. doi: 10.1111/aogs.1325 — View Citation

Moses RG. The recurrence rate of gestational diabetes in subsequent pregnancies. Diabetes Care. 1996 Dec;19(12):1348-50. doi: 10.2337/diacare.19.12.1348. — View Citation

Su M, Nie Y, Shao R, Duan S, Jiang Y, Wang M, Xing Z, Sun Q, Liu X, Xu W. Diversified gut microbiota in newborns of mothers with gestational diabetes mellitus. PLoS One. 2018 Oct 17;13(10):e0205695. doi: 10.1371/journal.pone.0205695. eCollection 2018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Gestational Diabetes Mellitus (GDM) Week 8 to post-delivery throughout their entire pregnancy		Up to approximately GA Week 37
Secondary	Global Clinical Outcome (GCO) Rank Score (GCO Rank)		Up to approximately GA Week 37; up to approximately 12 weeks post birth
Secondary	Number of Participants With OGTT Oral Glucose Intolerance Test		Up to approximately GA Week 37
Secondary	Number of Participants With live Birth		Up to approximately GA Week 37
Secondary	Number of Participants With Preterm Birth		Up to approximately GA Week 37
Secondary	Number of Participants at GA Week 24 Without an OGTT		GA Week 24-28
Secondary	Gestational age at First GDM		Up to approximately GA Week 37
Secondary	Gestational age at First Preeclampsia		Up to approximately GA Week 37
Secondary	Gestational age at Delivery		Up to approximately GA Week 37

External Links

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