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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Genders
Female
Accepts 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) 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Postpartum GDM 		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).
  • Diagnostic Test: 2-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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Ashley N Battarbww, MD, MSCR

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Ashley N Battarbee, MD, MSCR
205-975-2361
anbattarbee@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.