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

NCT01988987 | Completed

• 2 other identifiers: WUH 1231818-01705
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Gestational diabetes; Postpartum glucose testing; Impaired glucose metabolism; Diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Result of a postpartum 75-gram oral glucose tolerance test (GTT)

  6 weeks-6 months postpartum

Study Arms (1)

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

Interventions

Inpatient Postpartum GTT 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

Also known as: Glucose tolerance test, Oral glucose tolerance test, OGTT

Inpatient Postpartum GTT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women hospitalized for delivery at a teaching hospital.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

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

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; 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 Officials

• Jolene Muscat, M.D.

  NYU Winthrop Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 20, 2013
• Study Start: February 22, 2013
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

US (1)