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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

Tracking Information
First Submitted Date March 6, 2014
First Posted Date March 10, 2014
Last Update Posted Date February 25, 2020
Study Start Date October 2012
Actual Primary Completion Date May 4, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 6, 2014)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 6, 2014)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oral Glucose Tolerance Testing After Gestational Diabetes
Official Title Oral Glucose Tolerance Testing After Gestational Diabetes
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum for measurements of insulin, markers of inflammation
Sampling Method Non-Probability Sample
Study Population Primary cohort is obtained from a pregnant population at two academic medical centers.
Condition
  • Gestational Diabetes
  • Pregnancy
  • Obesity
Intervention Not Provided
Study Groups/Cohorts Gestational diabetes
Primary cohort is women with diagnosis of gestational diabetes without evidence of overt diabetes
Publications * Waters TP, Kim SY, Sharma AJ, Schnellinger P, Bobo JK, Woodruff RT, Cubbins LA, Haghiac M, Minium J, Presley L, Wolfe H, Hauguel-de Mouzon S, Adams W, Catalano PM. Longitudinal changes in glucose metabolism in women with gestational diabetes, from late pregnancy to the postpartum period. Diabetologia. 2020 Feb;63(2):385-394. doi: 10.1007/s00125-019-05051-0. Epub 2019 Dec 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 24, 2020)
118
Original Estimated Enrollment
 (submitted: March 6, 2014)
150
Actual Study Completion Date December 31, 2019
Actual Primary Completion Date May 4, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • Gestational diabetes

Exclusion Criteria:

  • Multiple gestations
  • pre-pregnancy diabetes
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02082301
Other Study ID Numbers IRB12-00581
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ted Waters, MetroHealth Medical Center
Study Sponsor MetroHealth Medical Center
Collaborators
  • Centers for Disease Control and Prevention
  • Loyola University
Investigators
Principal Investigator: Thaddeus Waters, MD Loyola University
PRS Account MetroHealth Medical Center
Verification Date February 2020