Clinical trial NCT06784674: Maternal Abdominal Morphology Assessment
Official title: Diabetes Prediction During Pregnancy Using Pancreas MRI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Infant Development
Pancreas
Diabetes
Keywords: Pregnancy
Pancreas
Diabetes
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2025-01-20
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators intend to enroll 87 total participants. The study population will consist of women who are under 14 weeks pregnant with a singleton gestation, aged 18-54, living in the Greater Austin Area.

Brief summary: Previous studies have shown that pancreas size tends to be smaller in individuals with diabetes compared to those without diabetes. The investigators have recently found that pancreas size increases during pregnancy. The MAMA study aims to examine changes in the pancreas that occur during pregnancy, in both pregnant mothers and their babies, and find out how they are affected by maternal diabetes.

The MAMA study is a prospective cohort study that will follow women and their babies through pregnancy and one year postpartum. Women aged 18-54, who are under 14 weeks pregnant are being recruited to participate in the MAMA study.

Detailed description: As pancreas size is thought to reflect pancreatic insulin production and/or islet mass, monitoring pancreas size during and after pregnancy may advance the investigators' understanding of gestational diabetes mellitus (GDM) incidence and progression. Information on pancreas size changes during pregnancy, typical fetal pancreatic development, the relationship between pancreas size and GDM risk, and the relationship between pancreas size and neonatal hypoglycemia are largely unknown. Through this project, magnetic resonance imaging (MRI) will be used to measure changes in pancreas size during pregnancy and the effect of maternal diabetes on these measures.

This prospective cohort study is observational and will include up to 87 pregnant women who are between 18-54 years old. Study visits will take place at approximately 15-18 weeks gestation, 24-28 weeks gestation, 34-38 weeks gestation, and 1 year-1 year and 2 months postpartum. At each study visit, participants will self-report their height and weight, have their blood pressure measured, have their blood drawn, have an HbA1c finger stick test, participate in oral glucose tolerance testing (OGTT), complete an MRI scan, and undergo continuous glucose monitoring (CGM).

Eligibility criteria: Inclusion Criteria:

* Pregnant women, with a singleton gestation
* Age 18 - 54 years at screening
* Gestational age \< 14 weeks
* Willing to commit to 1 year postpartum follow up
* Planning to remain in geographical vicinity of Austin for 1 year after delivery

Exclusion Criteria:

* Presence of any mechanically or magnetically activated implants
* Claustrophobia
* Other contraindication for MRI
* BMI ≥ 35.0 or maximum width less than 48 cm (necessary to fit within the MRI field of view)

Primary outcomes:
measure: Maternal Pancreatic Volume
timeFrame: 15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation as well as 1 year-1 year and 2 months postpartum.
measure: Fetal Pancreatic Volume
timeFrame: 15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation.
Secondary outcomes:
measure: Plasma Insulin
timeFrame: 15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation as well as 1 year-1 year and 2 months postpartum.
measure: Plasma Glucose
timeFrame: 15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation as well as 1 year-1 year and 2 months postpartum.
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Medical School Health Discovery Building
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Jack Virostko, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: