Recruiting

Observational Study

Sponsor:

University of Texas at Austin

Code:

NCT06784674

Conditions

Pregnancy Related

Infant Development

Pancreas

Diabetes

Eligibility Criteria

Sex: Female

Age: 18 - 54

Healthy Volunteers: Accepted

Interventions

No intervention

Study Details

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.

Conditions

Pregnancy Related

Infant Development

Pancreas

Diabetes

Study ID

NCT06784674

Start date

May 6, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 54

Healthy Volunteers: Accepted

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 Design

Enrollment

87 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

No intervention

Observational study

Primary outcome measure

  • 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. ]
  • Fetal Pancreatic Volume [ Time Frame: 15-18 weeks gestation, 24-28 weeks gestation, and 34-38 weeks gestation. ]

Central Contacts and Locations

Central contacts

Jack Virostko, Ph.D.

512-495-5126jack.virostko@austin.utexas.edu

Ingrid Harris, MPH

512-471-0999ingrid.harris@austin.utexas.edu

Locations

Dell Medical School Health Discovery Building

Recruiting

Austin, Texas, United States, 78701

Contacts

Ingrid Harris, MPH

5124710999ingrid.harris@austin.utexas.edu

More Information

Sponsor

University of Texas at Austin

Last update posted

Oct 22, 2025

Last verified

Oct, 2025

Keywords

  • Pregnancy
  • Pancreas
  • Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2025-10-22.