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Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia

Primary Purpose

Gestational Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gestational Diabetes

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • University of North Carolina at Chapel HillRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Postpartum GDM

Arm Description

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).

Outcomes

Primary Outcome Measures

Pancreatic beta cell function
Insulin secretion will be estimated using the Stomvall index and insulin sensitivity using the Matsuda index.

Secondary Outcome Measures

Maternal glycemia measured by CGM
% time in range
Maternal hyperglycemia measured by CGM
% time above range
Maternal glucose variability
Coefficient of variation (glucose standard deviation/mean glucose)
Pancreatic beta cell function
Insulin secretion will be estimated using the Stomvall index and insulin sensitivity using the Matsuda index.
Maternal and infant body fat composition
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
Fasting blood glucose >= 126mg/dL or 2-hour blood glucose >=200 mg/dL after 75g oral glucose load.

Full Information

First Posted
August 18, 2020
Last Updated
June 20, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT04521712
Brief Title
Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia
Official Title
Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Postpartum GDM
Arm Type
Experimental
Arm Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor
Intervention Description
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 Outcome Measure Information:
Title
Pancreatic beta cell function
Description
Insulin secretion will be estimated using the Stomvall index and insulin sensitivity using the Matsuda index.
Time Frame
4-6 weeks after delivery
Secondary Outcome Measure Information:
Title
Maternal glycemia measured by CGM
Description
% time in range
Time Frame
10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
Title
Maternal hyperglycemia measured by CGM
Description
% time above range
Time Frame
10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
Title
Maternal glucose variability
Description
Coefficient of variation (glucose standard deviation/mean glucose)
Time Frame
10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
Title
Pancreatic beta cell function
Description
Insulin secretion will be estimated using the Stomvall index and insulin sensitivity using the Matsuda index.
Time Frame
0-4 days and 6 months after delivery
Title
Maternal and infant body fat composition
Description
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.
Time Frame
0-4 days, 4-6 weeks, and 6 months after delivery
Title
Maternal diabetes mellitus
Description
Fasting blood glucose >= 126mg/dL or 2-hour blood glucose >=200 mg/dL after 75g oral glucose load.
Time Frame
4-6 weeks and 6 months after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley N Battarbee, MD, MSCR
Phone
205-975-2361
Email
anbattarbee@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Boggess, MD
Email
kim_boggess@med.unc.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley N Battarbww, MD, MSCR
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Boggess, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia

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