Gestational Diabetes Mellitus (GDM) in Pregnant Women
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ClinicalTrials.gov Identifier: NCT05265741 |
Recruitment Status :
Recruiting
First Posted : March 3, 2022
Last Update Posted : March 3, 2022
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Condition or disease | Intervention/treatment | Phase |
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Gestational Diabetes Mellitus Pregnancy Complications | Behavioral: Recommended Diet | Phase 1 |
The first line of management of GDM in the current healthcare system is diet. Women diagnosed through Oral Glucose Tolerance Tests at week 24-28 of gestation are prescribed a low carbohydrate diet to regulate glucose. If it fails, management is through insulin and pharmaceutical agents. The microbiome is dynamic and slowly changes depending upon the diet and gut environment. Literature also shows that GDM is a factor in microbiome alterations. Our trial is trying to find associations between diet, GDM, and the microbiome.
In order to achieve this, we have designed a trial that involves collection of fecal samples from pregnant women for microbiome analysis at different stages of pregnancy. We will also collect the nutritional data from the participants for a period of 4 weeks. Although GDM is diagnosed at or after 24 weeks, we will collect samples at first, second, and third trimesters to identify if the microbiome changes that happen before the appearance of symptoms.
Lastly, we will provide a 4 week diet for our interventional group designed by a Registered Dietician to reduce variables and confirm the validity of nutrition as a means of prevention of GDM.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 65 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Single Site, Interventional, Administered to Pregnant Women at High Risk for Gestational Diabetes Mellitus |
Actual Study Start Date : | February 11, 2022 |
Estimated Primary Completion Date : | February 11, 2023 |
Estimated Study Completion Date : | February 11, 2023 |

Arm | Intervention/treatment |
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No Intervention: ArmA_Random Diet Control
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 where they log the food items they consume. Their diet will not be altered as they are required to log their regular diet.
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Experimental: ArmB_Recommended Diet Experimental
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. Their diet will be altered and they will received pre-selected food items to consume during this period. The Recommended Diet is designed by a Registered Dietician to provide caloric and nutritional intake
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Behavioral: Recommended Diet
A diet designed by a Registered Dietician to fit the participants caloric and nutritional needs depending on the trimester |
No Intervention: ArmC_Non- Pregnant Control
This group is composed of non-pregnant women. This arm will be required to provide 1 fecal sample. It will be used as a baseline for comparison of the microbiome
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No Intervention: ArmD_Post-diagnosis Gestational Diabetes Control
This group is composed of pregnant women diagnosed with GDM in their current pregnancy through Oral Glucose Tolerance Test. This arm will be required to provide 1 fecal sample. It will be used as comparison of the microbiome of GDM women.
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- 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 ]
- Global Clinical Outcome (GCO) Rank Score (GCO Rank) [ Time Frame: Up to approximately GA Week 37; up to approximately 12 weeks post birth ]
- Number of Participants With OGTT Oral Glucose Intolerance Test [ Time Frame: Up to approximately GA Week 37 ]
- Number of Participants With live Birth [ Time Frame: Up to approximately GA Week 37 ]
- Number of Participants With Preterm Birth [ Time Frame: Up to approximately GA Week 37 ]
- Number of Participants at GA Week 24 Without an OGTT [ Time Frame: GA Week 24-28 ]
- Gestational age at First GDM [ Time Frame: Up to approximately GA Week 37 ]
- Gestational age at First Preeclampsia [ Time Frame: Up to approximately GA Week 37 ]
- Gestational age at Delivery [ Time Frame: Up to approximately GA Week 37 ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women between the age of 18-45 Groups A, B, and D have to be confirmed pregnant by blood test (confirmed from 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 Group D is women that fail their OGTT at routine testing on or after week 24 of pregnancy, but before they give birth (confirmed by medical records)
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05265741
Contact: Nini Fan, MS,MBA | 6469458999 | nini.fan@mamome.io |
United States, New York | |
Long Island University | Recruiting |
New York, New York, United States, 11201 | |
Contact: Nini Fan, MS MBA 646-945-8999 nini.fan@my.liu.edu | |
Contact: Joseph Morin, PHD 19292904244 joseph.morin@liu.edu |
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 of Results:
Responsible Party: | Nini Fan, Principal Investigator, Long Island University |
ClinicalTrials.gov Identifier: | NCT05265741 |
Other Study ID Numbers: |
Mamome-GDM-05 |
First Posted: | March 3, 2022 Key Record Dates |
Last Update Posted: | March 3, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gestational Diabetes Mellitus |
Diabetes, Gestational Pregnancy Complications Diabetes Mellitus |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |