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Oral Glucose Tolerance Testing After Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT02082301
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : February 25, 2020
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Loyola University
Information provided by (Responsible Party):
Ted Waters, MetroHealth Medical Center

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
Gestational Diabetes Pregnancy Obesity

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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 : October 2012
Actual Primary Completion Date : May 4, 2016
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Gestational diabetes
Primary cohort is women with diagnosis of gestational diabetes without evidence of overt diabetes



Primary Outcome Measures :
  1. Primary outcome: sensitivity of immediate post partum screen [ Time Frame: 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 [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Serum for measurements of insulin, markers of inflammation


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary cohort is obtained from a pregnant population at two academic medical centers.
Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • Gestational diabetes

Exclusion Criteria:

  • Multiple gestations
  • pre-pregnancy diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082301


Locations
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United States, Ohio
University Hospital
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
Centers for Disease Control and Prevention
Loyola University
Investigators
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Principal Investigator: Thaddeus Waters, MD Loyola University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ted Waters, Principal Investigator, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT02082301    
Other Study ID Numbers: IRB12-00581
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications