Maternal Abdominal Morphology Assessment

NCT06784674 | Recruiting DMC

• 1 other identifier: STUDY00005491
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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

Keywords

Pregnancy; Pancreas; Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Plasma Insulin

  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

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

Study Arms (1)

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

Interventions

No intervention OTHER

Observational study

MAMA Study Participants

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Dell Medical School Health Discovery Building

Austin, Texas, 78701, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Maternal blood samples will be collected at study visits.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jack Virostko, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jack Virostko, Ph.D.

CONTACT

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

Ingrid Harris, MPH

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: John Virostko, Associate Professor, Department of Diagnostic Medicine

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)