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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Winthrop University Hospital
Sponsor:
Collaborator:
Stony Brook University
Information provided by (Responsible Party):
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01988987
First received: November 14, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes, Gestational
Prediabetic State
Glucose Metabolism Disorders
Diabetes Mellitus
Other: Inpatient Postpartum GTT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating for Type-2 Diabetes in the Very Early Post-Partum Period

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • The comparability of oral glucose tolerance tests (GTT) obtained 2-4 days postpartum and 6-12 weeks postpartum. [ Time Frame: 2-4 days postpartum and 6-12 weeks postpartum. ] [ Designated as safety issue: No ]
    The GTT results obtained 2-4 days postpartum will be categorized as normal or abnormal, and compared to the GTT results (also categorized as normal or abnormal) obtained 6-12 weeks postpartum using the McNemar test for paired proportions.


Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned 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
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:
  • Glucose tolerance test
  • Oral glucose tolerance test
  • OGTT

Detailed Description:

This will be a prospective cohort study conducted at Winthrop-University Hospital and Stony Brook 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women hospitalized for delivery at a teaching hospital.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988987

Contacts
Contact: Corinne Yeh, M.D. (631) 444-7650 corinne.yeh@sbumed.org
Contact: Corinne Yeh, M.D. (516) 663-8661 cyeh@winthrop.org

Locations
United States, New York
Winthrop-University Hospital Not yet recruiting
Mineola, New York, United States, 11501
Contact: Corinne Yeh, M.D.       cyeh@winthrop.org   
Contact: Jolene Muscat, M.D.       jmuscat@winthrop.org   
Principal Investigator: Jolene Muscat, M.D.         
Sub-Investigator: Corinne Yeh, M.D.         
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Corinne Yeh, M.D.    631-444-7650    corinne.yeh@sbumed.org   
Contact: Elizabeth Roemer    (631) 444-9211    elizabeth.roemer@sbumed.org   
Principal Investigator: James Bernasko, M.D.         
Sub-Investigator: Corinne Yeh, M.D.         
Sponsors and Collaborators
Winthrop University Hospital
Stony Brook University
Investigators
Principal Investigator: Jolene Muscat, M.D. Winthrop University Hospital
Principal Investigator: James Bernasko, M.D. Stony Brook Medicine
  More Information

No publications provided

Responsible Party: Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01988987     History of Changes
Other Study ID Numbers: 12318
Study First Received: November 14, 2013
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
Gestational diabetes
Postpartum glucose testing
Impaired glucose metabolism
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Prediabetic State
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on October 22, 2014