Gestational Diabetes Mellitus (GDM) in Pregnant Women

NCT05265741 | Unknown

• 1 other identifier: Mamome-GDM-05
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gestational Diabetes Mellitus; Pregnancy Complications

Keywords

Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Gestational Diabetes Mellitus (GDM) Week 8 to post-delivery throughout their entire pregnancy

  Up to approximately GA Week 37

Secondary Outcomes (8)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Long Island University: lead
• BROOKLYN INNOSEQ INC.: collaborator

Study Sites (1)

Long Island University

New York, New York, 11201, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 30332459 RESULT

• 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.

  PMID: 29077989 RESULT

• 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.

  PMID: 8941462 RESULT

Related Links

• Related Info
• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Gut Microbiome (Fecal Sample)

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Joseph Morin, PhD

  Long Island University

  STUDY CHAIR

• Jeanmaire Molina, PhD

  Long Island University

  PRINCIPAL INVESTIGATOR

• Xuebin Yin, MD

  BROOKLYN INNOSEQ INC.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nini Fan, MS,MBA

CONTACT

6469458999; nini.fan@mamome.io

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 3, 2022
• Study Start: November 9, 2021
• Primary Completion: February 10, 2024
• Study Completion: December 31, 2024
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

US (1)