Maternal Abdominal Morphology Assessment

Recruiting

• Conditions: Pregnancy Related; Infant Development; Pancreas; Diabetes

• Registration Number: NCT06784674
• Lead Sponsor: University of Texas at Austin

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.

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 Timeline

• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Status Verified: 2025-05
• Study Start: 2025-05-06
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-30
• Primary Completion: 2030-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 87

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 ≥ 35.0 or maximum width less than 48 cm (necessary to fit within the MRI field of view)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal Pancreatic Volume	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.
Fetal Pancreatic Volume	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 Outcome Measures

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

Trial Locations

Locations (1)

Dell Medical School Health Discovery Building; 🇺🇸 Austin, Texas, United States