Gestational Diabetes MellitusNCT05265741
Gestational Diabetes Mellitus (GDM) in Pregnant Women
An observational study of Gestational Diabetes Mellitus and Pregnancy Complications, run by Long Island University at 1 site in United States.
Trial summary
The purpose of the trial is to discover and predict the development of GDM of pregnant women in their first trimester. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus, Pregnancy Complications
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Asian-American women who are patients of OBGYN, Dr. Xuebin Yin
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Long Island University
New York, New York, 11201
Nini Fan, MS MBA, 646-945-8999, nini.fan@my.liu.edu
Joseph Morin, PHD, 19292904244, joseph.morin@liu.edu
About this study
Official title: 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.
Read the 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.
- Keywords
- Gestational Diabetes Mellitus
- Medical subject headings
- Diabetes, Gestational, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Gestational Diabetes Mellitus (GDM) Week 8 to post-delivery throughout their entire pregnancy
Measured: Up to approximately GA Week 37
Secondary outcomes (8)
Global Clinical Outcome (GCO) Rank Score (GCO Rank)
Measured: Up to approximately GA Week 37; up to approximately 12 weeks post birth
Number of Participants With OGTT Oral Glucose Intolerance Test
Measured: Up to approximately GA Week 37
Number of Participants With live Birth
Measured: Up to approximately GA Week 37
Number of Participants With Preterm Birth
Measured: Up to approximately GA Week 37
Number of Participants at GA Week 24 Without an OGTT
Measured: GA Week 24-28
Gestational age at First GDM
Measured: Up to approximately GA Week 37
Gestational age at First Preeclampsia
Measured: Up to approximately GA Week 37
Gestational age at Delivery
Measured: Up to approximately GA Week 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start9 Nov 2021
- Primary completion10 Feb 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Long Island University
- Sponsor type
- University, hospital or other
- Collaborators
- BROOKLYN INNOSEQ INC.
- Responsible party
- Principal investigator, Nini Fan, Long Island University
- Investigators
- Joseph Morin, PhD, Study chair, Long Island UniversityJeanmaire Molina, PhD, Principal investigator, Long Island UniversityXuebin Yin, MD, Principal investigator, BROOKLYN INNOSEQ INC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265741
- Sponsor's protocol ID
- Mamome-GDM-05
- Status last verified
- Apr 2023
- First submitted
- 23 Feb 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30332459Hasan 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.
PubMed 29077989Moses 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.
PubMed 8941462
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Site, Observational, Administered to Pregnant Women at High Risk for Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05265741
- Acronym / sponsor ID
- Mamome-GDM-05
- Keywords
- Gestational Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Long Island UniversityUniversity, hospital or other
- Collaborators
- BROOKLYN INNOSEQ INC.
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 10 Feb 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial is to discover and predict the development of GDM of pregnant women in their first trimester.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Asian-American women who are patients of OBGYN, Dr. Xuebin Yin
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Results publication: PubMed 30332459Su 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.
- Results publication: PubMed 29077989Hasan 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.
- Results publication: PubMed 8941462Moses 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Morin, PhD study chair
Long Island University
Jeanmaire Molina, PhD principal investigator
Long Island University
Xuebin Yin, MD principal investigator
BROOKLYN INNOSEQ INC.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus and Pregnancy Complications, run by Long Island University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nini Fan, MS,MBA (6469458999, nini.fan@mamome.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05265741, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.