Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia
- Conditions
- Gestational Diabetes
- Interventions
- Diagnostic Test: 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor
- Registration Number
- NCT04521712
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
GDM is characterized by decreased insulin sensitivity, decreased insulin secretion, or a combination of both. Women with GDM are at significant risk for overt T2DM later in life, and postpartum insulin sensitivity and secretion in women with GDM has not been quantified, limiting our ability to optimize screening for overt T2DM. In addition, compliance with currently recommended postpartum T2DM screening by OGTT is poor. Quantification of postpartum insulin sensitivity and secretion in women at high risk for T2DM will inform strategies to improve diagnostic strategies. Continuous glucose monitoring (CGM) is a new technology that may be useful to identify women with persistent hyperglycemia. Understanding maternal glycemia and physiology that drives glycemia in the postpartum period is limited. Completion of this study will define postpartum maternal glycemia, quantify insulin secretion versus insulin sensitivity defects, and demonstrate the feasiblity of using continuous glucose monitoring to identify women most at risk for overt T2DM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Postpartum GDM 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor Women with GDM diagnosed early (\< 20 weeks gestation) or with routine 3rd trimester screening (\>=24 weeks) will be enrolled in this longitudinal study. All enrolled women will complete a oral glucose tolerance test and wear a continuous glucose monitor for 10 days at the 3 designated study time points (0-4 days, 4-6 weeks, and 6 months after delivery).
- Primary Outcome Measures
Name Time Method Pancreatic beta cell function 4-6 weeks after delivery Insulin secretion will be estimated using the Stomvall index and insulin sensitivity using the Matsuda index.
- Secondary Outcome Measures
Name Time Method Maternal glycemia measured by CGM 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery % time in range
Pancreatic beta cell function 0-4 days and 6 months after delivery Insulin secretion will be estimated using the Stomvall index and insulin sensitivity using the Matsuda index.
Maternal diabetes mellitus 4-6 weeks and 6 months after delivery Fasting blood glucose \>= 126mg/dL or 2-hour blood glucose \>=200 mg/dL after 75g oral glucose load.
Maternal glucose variability 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery Coefficient of variation (glucose standard deviation/mean glucose)
Maternal and infant body fat composition 0-4 days, 4-6 weeks, and 6 months after delivery Percentage body fat calculated from skin fold thickness measurements of upper mid-arm, triceps, subscapular, and flank along with height and weight for the mother and length, birthweight and head circumference for the infant.
Maternal hyperglycemia measured by CGM 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery % time above range
Trial Locations
- Locations (2)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States