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Oklahoma City, Oklahoma 73117


Purpose:

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.


Study summary:

The investigators will randomize 60 obese pregnant women with a new diagnosis of gestational diabetes using the Carpenter-Coustan criteria in a 1:1 fashion to either standard care or intensive therapy. Subjects will be randomized to either standard care or intensive therapy at the first study visit, which will occur between 12-32 weeks of gestation after they have completed their gestational diabetes testing. Neither patients nor their providers will be blinded to patient study group. All women will receive standard nutritional counseling at the time of diagnosis, and they will also be treated with either glyburide or insulin as dictated by standard care. Women will return for a second study visit between 32-36 weeks of gestation to assess the impact of their glycemic target groups on overall glycemic control. The investigators will also collect information on the type and dose of each medication required to maintain glycemic control in women randomized to either standard care or intensive therapy. In addition to standard glucose monitoring 4x/day (fasting and one-hour post breakfast, lunch, and dinner), the investigators will utilize blinded continuous glucose monitors (iPro, Medtronic) at each study visit. Because women with GDM are receiving active management of their blood sugars and dietary counseling, the investigators will assess CGM for 5 consecutive days both at study enrollment and again between 32-36 weeks. Study participants will complete food diaries during their CGM monitoring to correlate food intake with glycemic variation. The investigators will also compare maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration between groups.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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.


NCT ID:

NCT02530866


Primary Contact:

Principal Investigator
Christina Scifres, MD
University of Oklahoma


Backup Contact:

N/A


Location Contact:

Oklahoma City, Oklahoma 73117
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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