Oral Glucose Tolerance Testing After Gestational Diabetes

Obesity Clinical Trial

Official title:

Oral Glucose Tolerance Testing After Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082301
• Other study ID #: IRB12-00581
• Status: Completed
• Start date: October 2012
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 31, 2019
• Est. primary completion date: May 4, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Singleton pregnancy

• Gestational diabetes

Exclusion Criteria:

• Multiple gestations

• pre-pregnancy diabetes

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Obesity
• Pregnancy

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	University Hospital	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
MetroHealth Medical Center	Centers for Disease Control and Prevention, Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome: sensitivity of immediate post partum screen	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	Immediate post partum
Secondary	Secondary outcome: physiology	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.	3 time points: antepatum, immediate postpartum, 6 weeks post partum