Intensive Management for Gestational Diabetes

Completed · Not applicable

Conditions studied: Gestational Diabetes

In brief

This is a randomized clinical pilot trial designed to assess the feasibility of randomizing obese women with GDM to lower glycemic thresholds compared to standard care. Maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration will also be compared between groups.

Key facts

Study ID

NCT02530866

Run by

University of Oklahoma

People needed

60

Starts

2015-11-01

Expected to finish

2018-03-01

Last updated by the study team

2020-03-06

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• maternal age between 18-45 years
• singleton birth
• planned delivery at OU Medical Center
• GDM diagnosed between 12-32 weeks' gestation by either a 50 gram
• one hour GCT >200 mg/dL or two or more abnormal values on a 100 gram OGTT using the Carpenter-Coustan criteria
• pre-pregnancy BMI ≥26 kg/m2.

You may not qualify if…

• maternal tobacco use
• planned delivery prior to 34 weeks of gestation
• significant fetal anomalies
• chronic hypertension requiring medication
• other vascular disease
• known renal disease with a baseline serum creatinine >1.5 mg/dL
• maternal rheumatologic disorders requiring medication
• maternal human immunodeficiency virus (HIV) or hepatitis
• as the specimen storage facility is not accredited to handle such samples
• steroid use within 7 days.

Where it is running

• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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