Oral Glucose Tolerance Testing After Gestational Diabetes

NCT02082301 | Completed

• 1 other identifier: IRB12-00581
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 2

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.

Conditions

Gestational Diabetes; Pregnancy; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary outcome: physiology

  3 time points: antepatum, immediate postpartum, 6 weeks post partum

Study Arms (1)

Gestational diabetes

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary cohort is obtained from a pregnant population at two academic medical centers.

You may qualify if:

• Singleton pregnancy
• Gestational diabetes

You may not qualify if:

• Multiple gestations
• pre-pregnancy diabetes

Sponsors & Collaborators

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

Study Sites (2)

University Hospital

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (1)

• 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.

  PMID: 31820038 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum for measurements of insulin, markers of inflammation

MeSH Terms

Conditions

Diabetes, Gestational; Obesity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thaddeus Waters, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: October 1, 2012
• Primary Completion: May 4, 2016
• Study Completion: December 31, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

US (2)