Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia

NCT04521712 | Completed

• 1 other identifier: 300005510
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Pancreatic beta cell function

  Insulin secretion will be estimated using the Stomvall index and insulin sensitivity using the Matsuda index.

  4-6 weeks after delivery

Secondary Outcomes (6)

• Maternal glycemia measured by CGM

  10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery

• Maternal hyperglycemia measured by CGM

  10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery

• Maternal glucose variability

  10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery

• Pancreatic beta cell function

  0-4 days and 6 months after delivery

• Maternal and infant body fat composition

  0-4 days, 4-6 weeks, and 6 months after delivery

Study Arms (1)

Postpartum GDM

EXPERIMENTAL

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

Interventions

2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor DIAGNOSTIC_TEST

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.

Postpartum GDM

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• History of prediabetes or polycystic ovarian syndrome
• History of pregestational type 2 diabetes mellitus
• Skin conditions which prevent wearing a continuous glucose monitor
• 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)
• History of prediabetes or polycystic ovarian syndrome
• History of pregestational type 2 diabetes mellitus
• Skin conditions which prevent wearing a continuous glucose monitor

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (20)

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MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 20, 2020
• Study Start: September 17, 2021
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)