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NCT Number: NCT06784674

Maternal Abdominal Morphology Assessment

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.

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Key information

Age range

18 year–54 year

Sex eligibility

Female

Study type

Observational

Primary location

Dell Medical School Health Discovery Building

Austin, Texas, 78701, United States

Location status: Recruiting

Location contact

Ingrid Harris, MPH

CONTACT

[email protected]

5124710999

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

Observational study

Primary outcomes

  1. Maternal Pancreatic Volume

    Time frame: 15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation as well as 1 year-1 year and 2 months postpartum.

    Maternal pancreatic volume will be measured at each study visit. MRI will be utilized to determine maternal pancreatic volume in cm^3.

  2. Fetal Pancreatic Volume

    Time frame: 15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation.

    Fetal pancreatic volume will be measured at each study visit. MRI will be utilized to determine fetal pancreatic volume in utero in cm^3. Fetal pancreatic volume will not be ascertained at the final study visit.

Secondary outcomes

  1. Plasma Insulin

    Time frame: 15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation as well as 1 year-1 year and 2 months postpartum.

    Plasma Insulin values (µU/mL or pmol/L) measured via blood draw will be utilized to calculate Glycemic Control and Insulin Sensitivity.

  2. Plasma Glucose

    Time frame: 15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation as well as 1 year-1 year and 2 months postpartum.

    Plasma Insulin values (mg/dL or mmol/L) measured via blood draw will be utilized to calculate Glycemic Control and Insulin Sensitivity.

Study contacts

Contact information is provided by the study sponsor or research team.

Ingrid Harris, MPH

CONTACT

[email protected]

512-471-0999

Jack Virostko, Ph.D.

CONTACT

[email protected]

512-495-5126

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Diabetes Prediction During Pregnancy Using Pancreas MRI

Acronym: MAMA

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Jan 20, 2025
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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