Gestational Diabetes
Conditions
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.
Interventions
DIAGNOSTIC_TEST2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor
All women enrolled in this study will have a 2-hour 75-g oral glucose tolerance test performed immediately postpartum (within 4 days of delivery), at 4-6 weeks postpartum, and at 6 months postpartum. Enrolled women will also wear a continuous glucose monitor for 10 days at each of these time periods. Both women and their infants will have skin fold thickness measured at each of these 3 study visits to estimate body fat composition. Additionally umbilical cord blood and placental biopsies will be collected at delivery and stored for future research.
Sponsors
University of North Carolina, Chapel Hill
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
for early GDM women: * Live singleton gestation with no fetal anomalies at 34-40 weeks gestation * Gestational diabetes mellitus identified at \< 20 weeks' gestation requiring pharmacologic treatment (class A2)
Exclusion criteria
for early GDM women: * History of prediabetes or polycystic ovarian syndrome * History of pregestational type 2 diabetes mellitus * Skin conditions which prevent wearing a continuous glucose monitor Inclusion Criteria for 3rd trimester GDM women: * Live singleton gestation with no fetal anomalies at 34-40 weeks gestation * Gestational diabetes mellitus identified at \>= 24 weeks' gestation requiring pharmacologic treatment (class A2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 glycemia measured by CGM | 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery | % time in range |
| 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 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. |
| 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. |
Countries
United States
Outcome results
None listed