Dell Medical School Health Discovery Building
Austin, Texas, 78701, United States
Location status: Recruiting
NCT Number: NCT06784674
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.
Interested in participating?
Request Info18 year–54 year
Female
Observational
Austin, Texas, 78701, United States
Location status: Recruiting
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Observational study
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Ingrid Harris, MPH
CONTACT
Jack Virostko, Ph.D.
CONTACT
University of Texas at Austin
Other
Diabetes Prediction During Pregnancy Using Pancreas MRI
Acronym: MAMA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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