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Oral Glucose Tolerance Testing After Gestational Diabetes

Sponsor
MetroHealth Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02082301
Collaborator
Centers for Disease Control and Prevention (U.S. Fed), Loyola University (Other)
118
Enrollment
2
Locations
87
Duration (Months)
59
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an observation study of women with gestational diabetes. Subjects recruited undergo immediate postpartum diabetic screening prior to discharge. Post-partum screening for overt diabetes is repeated 6-12 weeks postpartum. The outcome of interest is the utility of an immediate post partum screen for overt diabetes compared to a traditional 6 week test.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    118 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Oral Glucose Tolerance Testing After Gestational Diabetes
    Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    May 4, 2016
    Actual Study Completion Date :
    Dec 31, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Gestational diabetes

    Primary cohort is women with diagnosis of gestational diabetes without evidence of overt diabetes

    Outcome Measures

    Primary Outcome Measures

    1. Primary outcome: sensitivity of immediate post partum screen [Immediate post partum]

      2 hour fasting 75g OGTT immediately post partum. This is compared to a traditional 6 week post partum 75g OGTT for the sensitivity, positive and negative predictive value of the immediate post partum test

    Secondary Outcome Measures

    1. Secondary outcome: physiology [3 time points: antepatum, immediate postpartum, 6 weeks post partum]

      A small sub-cohort of women will undergo an additional 2 hour fasting 75g OGTT in the third trimester with measurements of insulin, cytokines, lipids.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Singleton pregnancy

    • Gestational diabetes

    Exclusion Criteria:

    • Multiple gestations

    • pre-pregnancy diabetes

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Cleveland Ohio United States 44106
    2 MetroHealth Medical Center Cleveland Ohio United States 44109

    Sponsors and Collaborators

    • MetroHealth Medical Center
    • Centers for Disease Control and Prevention
    • Loyola University

    Investigators

    • Principal Investigator: Thaddeus Waters, MD, Loyola University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ted Waters, Principal Investigator, MetroHealth Medical Center
    ClinicalTrials.gov Identifier:
    NCT02082301
    Other Study ID Numbers:
    • IRB12-00581
    First Posted:
    Mar 10, 2014
    Last Update Posted:
    Feb 25, 2020
    Last Verified:
    Feb 1, 2020
    Additional relevant MeSH terms:
    Diabetes, Gestational
    Diabetes Mellitus

    Study Results

    No Results Posted as of Feb 25, 2020