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

NCT ID: NCT01988987

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 123 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-22
• Study Completion Date: 2018-11-30

Brief Summary

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.

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.

Conditions

Diabetes, Gestational; Prediabetic State; Glucose Metabolism Disorders; Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Inpatient Postpartum GTT

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Glucose tolerance test; Oral glucose tolerance test; OGTT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jolene Muscat, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYU Winthrop Hospital

Locations

NYU Winthrop Hospital

Mineola, New York, United States

Countries

United States

Other Identifiers

18-01705

Identifier Type: OTHER

Identifier Source: secondary_id

WUH 12318

Identifier Type: -

Identifier Source: org_study_id