Recruiting

Gestational Diabetes

Sponsor:

Long Island University

Code:

NCT05265741

Conditions

Gestational Diabetes Mellitus

Pregnancy Complications

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT05265741

Start date

Nov 9, 2021

Status verified date

Apr, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Feb 10, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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 Design

Enrollment

65 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Number of Participants with Gestational Diabetes Mellitus (GDM) Week 8 to post-delivery throughout their entire pregnancy [ Time Frame: Up to approximately GA Week 37 ]

Central Contacts and Locations

Central contacts

Locations

Long Island University

Recruiting

New York, New York, United States, 11201

Contacts

More Information

Sponsor

Long Island University

Last update posted

Apr 13, 2023

Last verified

Apr, 2023

Keywords

  • Gestational Diabetes Mellitus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Long Island University on 2023-04-13.