Maternal Abdominal Morphology Assessment (MAMA)

October 20, 2025 updated by: John Virostko, University of Texas at Austin

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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