Gestational Diabetes Mellitus (GDM) in Pregnant Women

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

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

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Gestational Diabetes Mellitus
• Intervention / Treatment: Behavioral: Recommended Diet

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.

• Study Type: Observational
• Enrollment (Anticipated): 65
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Nini Fan, MS,MBA; Phone Number: 6469458999; Email: nini.fan@mamome.io

Study Locations

• United States
  • New York
    • New York, New York, United States, 11201
      • Recruiting
      • Long Island University
      • Contact: Nini Fan, MS MBA; Phone Number: 646-945-8999; Email: nini.fan@my.liu.edu
      • Contact: Joseph Morin, PHD; Phone Number: 19292904244; Email: joseph.morin@liu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Asian-American women who are patients of OBGYN, Dr. Xuebin Yin

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
ArmA_Pregnant No Gestational Diabetes Mellitus; 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; 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; 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?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Number of Participants With live Birth	Up to approximately GA Week 37
Gestational age at Delivery	Up to approximately GA Week 37
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 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

Collaborators and Investigators

• Sponsor: Long Island University
• Collaborators: BROOKLYN INNOSEQ INC.
• Investigators: Study Chair: Joseph Morin, PhD, Long Island University; Principal Investigator: Jeanmaire Molina, PhD, Long Island University; Principal Investigator: Xuebin Yin, MD, BROOKLYN INNOSEQ INC.

Publications and helpful links

General Publications

• 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.
• 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.13252.
• 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.

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Anticipated): February 10, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Gestational Diabetes Mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: Mamome-GDM-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No