Evaluating for Type-2 Diabetes in the Very Early Postpartum Period

Evaluating for Type-2 Diabetes in the Very Early Post-Partum Period

Pregnancy-associated diabetes, known as gestational diabetes mellitus (GDM), is associated with an increased lifetime risk of developing diabetes mellitus (DM) or pre-diabetes. Up to 30% of women with GDM will continue have abnormal blood glucose tests 6 or more weeks after delivery. Early diagnosis and treatment of continued impaired glucose metabolism or DM is essential because serious health problems can result.

Current guidelines recommend a 75-gram, 2-hour glucose tolerance test (GTT) 6 or more weeks after delivery for women diagnosed with GDM in order to identify those with continued DM or impaired glucose metabolism. However, approximately half of these women do not get glucose testing after delivery. The ability to test women while they are still hospitalized after having a baby could greatly increase diagnosis, care and treatment of women with abnormal glucose metabolism.

Our objective is to determine if a 75-gram, 2-hour GTT administered to women with GDM two to four days after delivery can identify those who will have an abnormal GTT at 6-12 weeks after delivery.

Study Overview

• Status: Completed
• Conditions: Glucose Metabolism Disorders; Diabetes Mellitus; Prediabetic State; Diabetes, Gestational
• Intervention / Treatment: Other: Inpatient Postpartum GTT

Detailed Description

This will be a prospective cohort study conducted at Winthrop-University Hospital. Women 18 years old or older who delivered a child or fetus within the previous 4 days at either hospital who also were diagnosed with GDM during the pregnancy will be eligible for participation. Women will be excluded if they have issues that would interfere with administration of a GTT, are unable /unwilling to provide informed consent, or cannot follow up. Anticipated enrollment will be 250 women at each study site.

While still hospitalized two to four days postpartum, subjects will undergo a 75-gram, 2-hour GTT and have blood tested for hemoglobin A1c and glucose levels. They will be reminded to do the recommended GTT 6-12 weeks after delivery. Maternal, neonatal, and obstetric characteristics will be collected, including the any GTT results. The results of the in-hospital GTT will be compared to the result of the GTT taken 6-12 weeks postpartum and tested for correlation.

• Study Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • NYU Winthrop Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women hospitalized for delivery at a teaching hospital.

Description

Inclusion Criteria:

• Women 18 years old or older
• Delivered a child or fetus within the previous 4 days
• Diagnosed with gestational diabetes during the pregnancy

Exclusion Criteria:

• Unable or unwilling to provide informed consent for the study
• Unable to undergo or complete a 2-hour oral glucose tolerance test 2-4 days postpartum
• Unable or unwilling to have study follow up.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inpatient Postpartum GTT; Women with gestational diabetes will undergo a 75 gram, 2 hour, oral glucose tolerance test 2-4 days postpartum prior to hospital discharge, in addition to undergoing the standard of care, outpatient glucose tolerance test performed 6-12 weeks postpartum	Other: Inpatient Postpartum GTT; Women with gestational diabetes will undergo a 75 gram, 2 hour, oral glucose tolerance test 2-4 days postpartum prior to hospital discharge, in addition to undergoing the standard of care, outpatient glucose tolerance test performed 6-12 weeks postpartum; Other Names: OGTT; Glucose tolerance test; Oral glucose tolerance test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Result of an early postpartum 75-gram oral glucose tolerance test (GTT) result	The GTT result obtained 2-4 days postpartum will be compared to the GTT result obtained 6-12 weeks postpartum using the McNemar test for paired proportions.	2-4 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Result of a postpartum 75-gram oral glucose tolerance test (GTT)	The GTT result obtained 2-4 days postpartum will be compared to the GTT result obtained 6-12 weeks postpartum using the McNemar test for paired proportions.	6 weeks-6 months postpartum

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Jolene Muscat, M.D., NYU Winthrop Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2013
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: November 14, 2013
• First Submitted That Met QC Criteria: November 14, 2013
• First Posted (Estimate): November 20, 2013

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes mellitus; Gestational diabetes; Postpartum glucose testing; Impaired glucose metabolism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Prediabetic State; Metabolic Diseases; Diabetes, Gestational; Glucose Metabolism Disorders
• Other Study ID Numbers: WUH 12318; 18-01705 (Other Identifier: New York Langone Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided