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OpenTrials
Completed

NCT Number: NCT04521712

Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pancreatic beta cell function

    Time frame: 4-6 weeks after delivery

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

Secondary outcomes

  1. Maternal glycemia measured by CGM

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

    % time in range

  2. Maternal hyperglycemia measured by CGM

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

    % time above range

  3. Maternal glucose variability

    Time frame: 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)

  4. Pancreatic beta cell function

    Time frame: 0-4 days and 6 months after delivery

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

  5. Maternal and infant body fat composition

    Time frame: 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.

  6. Maternal diabetes mellitus

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2020
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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