Clinical trial NCT04860336: Glycemic Observation and Metabolic Outcomes in Mothers and Offspring
Official title: Glycemic Observation and Metabolic Outcomes in Mothers and Offspring / Glycemic Profile of Pregnancy Consortium
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gestational Diabetes
Pregnancy Related
Keywords: gestational diabetes
continuous glucose monitor
oral glucose tolerance test
gestational diabetes mellitus
GDM
OGTT
CGM
glucose tolerance test
glycemic regulation
pregnancy
large for gestational age
observational
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Yale University
name: Women and Infants Hospital of Rhode Island
name: University of Pittsburgh
name: Massachusetts General Hospital
name: Tufts Medical Center
name: Columbia University
name: Kaiser Permanente
First posted: 2021-04-26
Enrollment: 2179
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant adults who enroll prior to 10w0d-14w0d gestation.

Brief summary: The overarching goal of Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs) is to perform a comprehensive, longitudinal description of maternal glycemia over the course of pregnancy and to evaluate how glucose levels throughout pregnancy relate to traditional third trimester gestational diabetes mellitus (GDM) screening and perinatal outcomes.

Detailed description: GO MOMs is an observational study designed to characterize the glycemic profile of pregnancy using continuous glucose monitoring (CGM) technology in order to develop criteria using CGM measurements and/or early pregnancy oral glucose tolerance testing (OGTT) at 10w0d-14w0d gestation that are predictive, along with clinical factors, of adverse pregnancy outcomes in mothers and their newborns. GO MOMs involves multiple institutions and an anticipated 2179 participants. Participants will attend 4 research study visits: Visit 1 (10w0d-14w0d gestation), Visit 2 (16w0d-20w0d gestation), Visit 3 (24w0d-28w0d gestation), and Visit 4 (32w0d-36w0d gestation). Additional data will be collected at a Delivery Visit and via chart abstraction. Mothers will have a Remote Follow-up call after delivery to collect additional data. At Visits 1-4, a blinded CGM sensor will be placed. Participants will be instructed to wear the sensor for 10 days after which time they will follow instructions to return it to their study site. At Visit 1 (10w0d-14w0d gestation), participants will undergo a 75 g 2-hour (hr) OGTT. At Visit 3 (24w0d-28w0d gestation), participants will undergo a 100 g 3 hr OGTT. Visit 1 will include an extended maternal interview to collect social and demographic, medical history, obstetrical history, surgical history, family medical history, current health and pregnancy, and lifestyle (sleep, alcohol, tobacco use) data. Medical history, alcohol and tobacco use data will be updated at each study visit. Sleep data will be updated at Visit 3 (24w0d-28w0d gestation). Blood and urine samples will also be obtained at each visit for additional laboratory testing and some will be stored for ancillary investigations. At the Delivery Visit, newborn physical measurements including weight, length and skinfolds will be performed. Birthweight at delivery will also be obtained through chart abstraction. Primary statistical analyses will be performed to develop predictive criteria based on CGM and/or OGTT measures at Visit 1 (10w0d-14w0d gestation) along with clinical factors for primary maternal and newborn outcomes. Secondary analyses will further refine predictive models and will evaluate associations of maternal glucose with secondary outcomes and longitudinal modeling of maternal glycemia over the course of pregnancy.

GO MOMs Nutrition Substudy: The GO MOMs Nutrition Study is an observational substudy nested within the GO MOMs parent study. The goal of the study is to describe self-reported dietary components in a diverse cohort of pregnant individuals and to study the relationship between maternal diet and outcomes including maternal glycemia, maternal insulin physiology, infant birth weight, and infant fat mass. Participants will complete 6 dietary recalls via the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool during their pregnancies (Figure). Two will occur at visits and four will be unannounced, meaning they are completed on a random day without advance notice, during CGM wear. In addition, stored samples from all GO MOMs participants at visit 1 and 3 will be assayed for other nutritional markers. Primary statistical analyses will be used to identify associations between dietary carbohydrate content at \<22 weeks' gestation and maternal glycemia 24-28 weeks' gestation and neonatal birthweight.

Eligibility criteria: Inclusion Criteria:

* Maternal age \>=18 at consent
* Singleton gestation
* 10w0d-14w0d gestation at the time of the Visit 1 OGTT and CGM placement according to study dating criteria
* Conceived using own oocyte
* Willing and able to wear CGM as directed and adhere to CGM instructions
* Planning to deliver at GO MOMs-affiliated hospital (see list of accrual sites in the protocol section "Key Roles and Contact Information").

Exclusion Criteria:

* Pre-existing diabetes at enrollment
* Currently self-monitoring blood glucose
* Current use of medication with glycemic effects
* Fetal malformation evident at or before enrollment that is likely lethal. This includes, but is not limited to, malformations such as anencephaly, hydrops, diffuse subcutaneous edema or cystic hygroma, ectopic cordis, and encephalocele
* Known fetal aneuploidy based on chorionic villus sampling
* Participation in other research study that may modify glycemic profile or study outcomes
* History of bariatric surgery
* Extensive skin changes or diseases making CGM sensor use problematic
* Significant allergy to adhesive
* Previous participation in GO MOMs
* Current bulimia or anorexia nervosa
* Overnight shift work that alters the sleep/wake periods
* Hemoglobin A1c \>= 6.5%, fasting glucose \>= 126 mg/dL or 2 hr glucose \>= 200 mg/dL noted during OGTT at 10w0d-14w0d gestation
* Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the site investigator

Primary outcomes:
measure: Gestational diabetes (GDM)
timeFrame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
measure: Large for gestational age (LGA)
timeFrame: Delivery
Secondary outcomes:
measure: Hypertension
timeFrame: Evaluated 30-90 days after delivery through chart abstraction for any events occurring during pregnancy
measure: Cesarean delivery
timeFrame: Delivery
measure: Sum of skinfolds
timeFrame: Within 72 hours after delivery
measure: Small for gestational age (SGA)
timeFrame: Delivery
measure: Preterm birth
timeFrame: Delivery
measure: Shoulder dystocia
timeFrame: Delivery
measure: Neonatal birth injury
timeFrame: Delivery
measure: Neonatal hypoglycemia
timeFrame: Within 30 days after delivery
measure: Neonatal respiratory morbidity
timeFrame: Within 30 days after delivery
measure: Neonatal hyperbilirubinemia
timeFrame: Within 30 days after delivery
measure: Nutrition Substudy: Mean CGM glucose in mothers
timeFrame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
measure: Nutrition Substudy: Percent time above various glycemic thresholds at 24-28 weeks
timeFrame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
measure: Nutrition Substudy: Mean nocturnal glucose
timeFrame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
measure: Nutrition Substudy: Percent time above various glycemic thresholds at 16-36 weeks
timeFrame: When participants are between 16 weeks 0 days pregnant to 36 weeks 0 days pregnant
measure: Nutrition Substudy: Insulin resistance
timeFrame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
measure: Nutrition Substudy: Insulin secretory response
timeFrame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
measure: Nutrition Substudy: gestational diabetes mellitus diagnosis
timeFrame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
measure: Nutrition Substudy: Neonatal fat mass
timeFrame: Within 72 hours of delivery
measure: Nutrition Substudy: large for gestational age birthweight
timeFrame: Delivery
measure: Nutrition Substudy: Birthweight for gestational age percentile
timeFrame: Delivery
Other outcomes:
measure: Neonatal intensive care unit (NICU) admissions
timeFrame: Within 30 days after delivery
measure: Length of hospital admission
timeFrame: Within 30 days after delivery
measure: Spontaneous abortion
timeFrame: Prior to 20 weeks' gestation
measure: Stillbirth
timeFrame: Delivery
measure: Neonatal death
timeFrame: Within 30 days after delivery
measure: Major congenital malformation
timeFrame: Within 30 days after delivery
measure: Antepartum admissions or maternal readmissions
timeFrame: Within 30 days after delivery
measure: Apgar score <7 at 5 minutes
timeFrame: Delivery
measure: Nutrition Substudy: Maternal fasting triglycerides
timeFrame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
measure: Nutrition Substudy: Maternal fasting free fatty acids
timeFrame: When participants are between 24 weeks 0 days pregnant to 28 weeks 0 days pregnant
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Honolulu
country: United States
facility: Kaiser Permanente - Hawaii
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Columbia University
state: New York
city: Portland
country: United States
facility: Kaiser Permanente - Northwest
state: Oregon
city: Pittsburgh
country: United States
facility: Magee Womens Research Institute & Foundation
state: Pennsylvania
city: Providence
country: United States
facility: Women and Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Northwestern University
name: Denise Scholtens, PhD
role: PRINCIPAL_INVESTIGATOR
References: