Clinical trial NCT05265741: Gestational Diabetes Mellitus (GDM) in Pregnant Women
Official title: A Single Site, Observational, Administered to Pregnant Women at High Risk for Gestational Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes Mellitus
Pregnancy Complications
Keywords: Gestational Diabetes Mellitus
Lead sponsor: Long Island University
Sponsor class: OTHER
Collaborators: name: BROOKLYN INNOSEQ INC.
First posted: 2022-03-03
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asian-American women who are patients of OBGYN, Dr. Xuebin Yin

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Gestational Diabetes Mellitus (GDM) Week 8 to post-delivery throughout their entire pregnancy
timeFrame: Up to approximately GA Week 37
Secondary outcomes:
measure: Global Clinical Outcome (GCO) Rank Score (GCO Rank)
timeFrame: Up to approximately GA Week 37; up to approximately 12 weeks post birth
measure: Number of Participants With OGTT Oral Glucose Intolerance Test
timeFrame: Up to approximately GA Week 37
measure: Number of Participants With live Birth
timeFrame: Up to approximately GA Week 37
measure: Number of Participants With Preterm Birth
timeFrame: Up to approximately GA Week 37
measure: Number of Participants at GA Week 24 Without an OGTT
timeFrame: GA Week 24-28
measure: Gestational age at First GDM
timeFrame: Up to approximately GA Week 37
measure: Gestational age at First Preeclampsia
timeFrame: Up to approximately GA Week 37
measure: Gestational age at Delivery
timeFrame: Up to approximately GA Week 37
Other outcomes:
Locations:
city: New York
country: United States
facility: Long Island University
state: New York
Study officials:
affiliation: Long Island University
name: Joseph Morin, PhD
role: STUDY_CHAIR
affiliation: Long Island University
name: Jeanmaire Molina, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: BROOKLYN INNOSEQ INC.
name: Xuebin Yin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.