Maternal Abdominal Morphology Assessment (MAMA)

Diabetes Prediction During Pregnancy Using Pancreas MRI

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Pregnancy Related; Infant Development; Pancreas
• Intervention / Treatment: Other: No intervention

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).

• Study Type: Observational
• Enrollment (Estimated): 87

Contacts and Locations

• Study Contact: Name: Jack Virostko, Ph.D.; Phone Number: 512-495-5126; Email: jack.virostko@austin.utexas.edu
• Study Contact Backup: Name: Ingrid Harris, MPH; Phone Number: 512-471-0999; Email: ingrid.harris@austin.utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78701
      • Recruiting
      • Dell Medical School Health Discovery Building
      • Contact: Ingrid Harris, MPH; Phone Number: 5124710999; Email: ingrid.harris@austin.utexas.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MAMA Study Participants; 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.	Other: No intervention; Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Pancreatic Volume	Maternal pancreatic volume will be measured at each study visit. MRI will be utilized to determine maternal pancreatic volume in cm^3.	15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation as well as 1 year-1 year and 2 months postpartum.
Fetal Pancreatic Volume	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.	15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Insulin	Plasma Insulin values (µU/mL or pmol/L) measured via blood draw will be utilized to calculate Glycemic Control and Insulin Sensitivity.	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 Glucose	Plasma Insulin values (mg/dL or mmol/L) measured via blood draw will be utilized to calculate Glycemic Control and Insulin Sensitivity.	15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation as well as 1 year-1 year and 2 months postpartum.

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Jack Virostko, Ph.D., University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; Pregnancy; Pancreas
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: STUDY00005491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No