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Gestational Diabetes Mellitus (GDM) in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05265741
Recruitment Status : Recruiting
First Posted : March 3, 2022
Last Update Posted : March 3, 2022
Sponsor:
Collaborator:
BROOKLYN INNOSEQ INC.
Information provided by (Responsible Party):
Nini Fan, Long Island University

Study Description
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Brief Summary:
The purpose of this trial is to investigate the effects of diet on the naturally occurring bacterial population (the microbiome) inhabiting the gut of pregnant women and their connection to development of gestational diabetes mellitus (GDM).

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Pregnancy Complications Behavioral: Recommended Diet Phase 1

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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Arm Intervention/treatment
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.
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
 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
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Global Clinical Outcome (GCO) Rank Score (GCO Rank) [ Time Frame: Up to approximately GA Week 37; up to approximately 12 weeks post birth ]
  2. Number of Participants With OGTT Oral Glucose Intolerance Test [ Time Frame: Up to approximately GA Week 37 ]
  3. Number of Participants With live Birth [ Time Frame: Up to approximately GA Week 37 ]
  4. Number of Participants With Preterm Birth [ Time Frame: Up to approximately GA Week 37 ]
  5. Number of Participants at GA Week 24 Without an OGTT [ Time Frame: GA Week 24-28 ]
  6. Gestational age at First GDM [ Time Frame: Up to approximately GA Week 37 ]
  7. Gestational age at First Preeclampsia [ Time Frame: Up to approximately GA Week 37 ]
  8. Gestational age at Delivery [ Time Frame: Up to approximately GA Week 37 ]

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Nini Fan, MS,MBA 6469458999 nini.fan@mamome.io

Locations
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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   
Sponsors and Collaborators
Long Island University
BROOKLYN INNOSEQ INC.
Investigators
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Study Chair: Joseph Morin, PhD Long Island University
Principal Investigator: Jeanmaire Molina, PhD Long Island University
Principal Investigator: Xuebin Yin, MD BROOKLYN INNOSEQ INC.
More Information
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Additional Information:

Publications of Results:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nini Fan, Long Island University:
Gestational Diabetes Mellitus
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases