Clinical trial NCT04521712: Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia
Official title: Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2020-08-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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)

Exclusion Criteria for 3rd trimester 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

Primary outcomes:
measure: Pancreatic beta cell function
timeFrame: 4-6 weeks after delivery
Secondary outcomes:
measure: Maternal glycemia measured by CGM
timeFrame: 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
measure: Maternal hyperglycemia measured by CGM
timeFrame: 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
measure: Maternal glucose variability
timeFrame: 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
measure: Pancreatic beta cell function
timeFrame: 0-4 days and 6 months after delivery
measure: Maternal and infant body fat composition
timeFrame: 0-4 days, 4-6 weeks, and 6 months after delivery
measure: Maternal diabetes mellitus
timeFrame: 4-6 weeks and 6 months after delivery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
References:
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