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Maternal Abdominal Morphology Assessment (MAMA)

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Enrolling

Conditions

Diabetes
Pregnancy Related
Pancreas
Infant Development

Treatments

Other: No intervention

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT06784674
STUDY00005491

Details and patient eligibility

About

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.

Full 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).

Enrollment

87 estimated patients

Sex

Female

Ages

18 to 54 years old

Volunteers

Accepts Healthy Volunteers

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 ≥ 38.0 or maximum width less than 48 cm (necessary to fit within the MRI field of view)

Trial design

87 participants in 1 patient group

MAMA Study Participants
Description:
Approximately 87 pregnant women, aged 18-54, living in the Greater Austin area, will participate in the MAMA study. The MAMA study is an observational study.
Treatment:
Other: No intervention

Trial contacts and locations

1

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Central trial contact

Ingrid Harris, MPH; Jack Virostko, Ph.D.

Data sourced from clinicaltrials.gov

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